Trial Outcomes & Findings for Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer (NCT NCT01547741)
NCT ID: NCT01547741
Last Updated: 2026-08-06
Results Overview
The time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4242 participants
Primary outcome timeframe
Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.
Results posted on
2026-08-06
Participant Flow
Participant milestones
| Measure |
Arm 1: Anthracycline-based Chemotherapy
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D).
Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles.
Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses.
Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses.
Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Doxorubicin
Cyclophosphamide
Docetaxel
Paclitaxel
|
Arm 2: Docetaxel + Cyclophosphamide
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
Cyclophosphamide
Docetaxel
|
|---|---|---|
|
Overall Study
STARTED
|
2117
|
2125
|
|
Overall Study
COMPLETED
|
2062
|
2094
|
|
Overall Study
NOT COMPLETED
|
55
|
31
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Anthracycline-based Chemotherapy
n=2117 Participants
Anthracycline-based chemotherapy
|
Docetaxel + Cyclophosphamide
n=2125 Participants
docetaxel + cyclophosphamide
|
Total
n=4242 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 10.0 • n=20 Participants
|
55 years
STANDARD_DEVIATION 9.9 • n=20 Participants
|
54 years
STANDARD_DEVIATION 9.9 • n=40 Participants
|
|
Sex: Female, Male
Female
|
2117 Participants
n=20 Participants
|
2125 Participants
n=20 Participants
|
4242 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
White
|
1776 Participants
n=20 Participants
|
1821 Participants
n=20 Participants
|
3597 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Black
|
226 Participants
n=20 Participants
|
240 Participants
n=20 Participants
|
466 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Hawaiian/Pacific
|
9 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Asian
|
50 Participants
n=20 Participants
|
36 Participants
n=20 Participants
|
86 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska
|
10 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
7 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
39 Participants
n=20 Participants
|
20 Participants
n=20 Participants
|
59 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.The time to local recurrence following mastectomy, invasive local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, invasive contralateral breast cancer, second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
Outcome measures
| Measure |
Arm 1: Anthracycline-based Chemotherapy
n=2062 Participants
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D).
Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles.
Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses.
Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses.
Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Doxorubicin
Cyclophosphamide
Docetaxel
Paclitaxel
|
Arm 2: Docetaxel + Cyclophosphamide
n=2094 Participants
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
Cyclophosphamide
Docetaxel
|
|---|---|---|
|
Invasive Disease-free Survival (IDFS)
|
90.7 percentage of participants
Interval 89.2 to 92.2
|
88.2 percentage of participants
Interval 86.6 to 89.9
|
SECONDARY outcome
Timeframe: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.Population: Patients with follow-up
The time to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant recurrence, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer.
Outcome measures
| Measure |
Arm 1: Anthracycline-based Chemotherapy
n=2062 Participants
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D).
Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles.
Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses.
Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses.
Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Doxorubicin
Cyclophosphamide
Docetaxel
Paclitaxel
|
Arm 2: Docetaxel + Cyclophosphamide
n=2094 Participants
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
Cyclophosphamide
Docetaxel
|
|---|---|---|
|
Disease-free Survival (DFS-DCIS)
|
90.6 percentage of participants
Interval 89.1 to 92.1
|
88.0 percentage of participants
Interval 86.3 to 89.7
|
SECONDARY outcome
Timeframe: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.Population: Patients with follow-up
Time from randomization until death from any cause.
Outcome measures
| Measure |
Arm 1: Anthracycline-based Chemotherapy
n=2062 Participants
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D).
Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles.
Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses.
Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses.
Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Doxorubicin
Cyclophosphamide
Docetaxel
Paclitaxel
|
Arm 2: Docetaxel + Cyclophosphamide
n=2094 Participants
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
Cyclophosphamide
Docetaxel
|
|---|---|---|
|
Overall Survival (OS)
|
95.0 percentage of participants
Interval 93.9 to 96.2
|
94.7 percentage of participants
Interval 93.5 to 95.9
|
SECONDARY outcome
Timeframe: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.Population: Patients with follow-up
Time from randomization until local, regional, or distant recurrence.
Outcome measures
| Measure |
Arm 1: Anthracycline-based Chemotherapy
n=2062 Participants
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D).
Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles.
Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses.
Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses.
Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Doxorubicin
Cyclophosphamide
Docetaxel
Paclitaxel
|
Arm 2: Docetaxel + Cyclophosphamide
n=2094 Participants
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
Cyclophosphamide
Docetaxel
|
|---|---|---|
|
Recurrence-free Interval (RFI)
|
93.3 percentage of participants
Interval 91.9 to 94.6
|
90.0 percentage of participants
Interval 88.5 to 91.6
|
SECONDARY outcome
Timeframe: Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly years 6-10.Population: The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.
Adverse events categorized using the NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Outcome measures
| Measure |
Arm 1: Anthracycline-based Chemotherapy
n=913 Participants
4 anthracycline-based chemotherapy regimens (Regimens A, B, C, or D).
Regimen A (TAC): 75 mg/m2 docetaxel (T) + 50 mg/m2 doxorubicin (A) + 500 mg/m2 cyclophosphamide (C) IV every 3 weeks for 6 cycles.
Regimen B (AC then WP): 60 mg/m2 doxorubicin (A) + 600 mg/m2 cyclophosphamide (C) every 3 weeks for 4 cycles followed by weekly paclitaxel (WP) 80 mg/m2 IV every week for 12 doses.
Regimen C (DD AC then WP): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by weekly paclitaxel 80 mg/m2 IV every week for 12 doses.
Regimen D (DD AC then DD P): 60 mg/m2 doxorubicin + 600 mg/m2 cyclophosphamide every 2 weeks for 4 cycles followed by paclitaxel (P) 175 mg/m2 IV every 2 weeks for 4 cycles.
Doxorubicin
Cyclophosphamide
Docetaxel
Paclitaxel
|
Arm 2: Docetaxel + Cyclophosphamide
n=919 Participants
TC: 75 mg/m2 docetaxel and 600 mg/m2 cyclophosphamide IV every 3 weeks for 6 cycles
Cyclophosphamide
Docetaxel
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
92.0 percentage of participants
|
89.6 percentage of participants
|
Adverse Events
Anthracycline-based Chemotherapy
Serious events: 12 serious events
Other events: 798 other events
Deaths: 102 deaths
Docetaxel + Cyclophosphamide
Serious events: 10 serious events
Other events: 763 other events
Deaths: 111 deaths
Serious adverse events
| Measure |
Anthracycline-based Chemotherapy
n=915 participants at risk
Anthracycline-based chemotherapy
|
Docetaxel + Cyclophosphamide
n=920 participants at risk
docetaxel + cyclophosphamide
|
|---|---|---|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.11%
1/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.00%
0/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Cardiac disorders
Cardiac arrest
|
0.11%
1/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.00%
0/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Investigations
Cardiac troponin I increased
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Investigations
CPK increased
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.11%
1/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.33%
3/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
General disorders
Multi-organ failure
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.22%
2/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.00%
0/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.22%
2/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy, puerperium and perinatal conditions - Other, specify
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Infections and infestations
Sepsis
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
General disorders
Sudden death NOS
|
0.00%
0/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Nervous system disorders
Syncope
|
0.33%
3/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.00%
0/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Vascular disorders
Thromboembolic event
|
0.11%
1/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.00%
0/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukemia secondary to oncology chemotherapy
|
0.22%
2/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.11%
1/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.11%
1/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
0.00%
0/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
Other adverse events
| Measure |
Anthracycline-based Chemotherapy
n=915 participants at risk
Anthracycline-based chemotherapy
|
Docetaxel + Cyclophosphamide
n=920 participants at risk
docetaxel + cyclophosphamide
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
40.3%
369/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
38.5%
354/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Blood and lymphatic system disorders
Anemia
|
21.4%
196/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
12.2%
112/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.8%
126/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
12.0%
110/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.0%
128/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
14.5%
133/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Gastrointestinal disorders
Constipation
|
6.1%
56/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
5.5%
51/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
102/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
9.6%
88/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Gastrointestinal disorders
Diarrhea
|
16.4%
150/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
16.2%
149/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
General disorders
Fatigue
|
40.2%
368/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
35.9%
330/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
39/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
8.6%
79/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Nervous system disorders
Headache
|
10.4%
95/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
5.7%
52/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.3%
67/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
7.8%
72/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Vascular disorders
Hypertension
|
11.5%
105/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
11.2%
103/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Psychiatric disorders
Insomnia
|
4.8%
44/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
5.5%
51/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Investigations
Lymphocyte count decreased
|
10.7%
98/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
8.6%
79/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Gastrointestinal disorders
Mucositis oral
|
19.2%
176/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
9.9%
91/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
14.3%
131/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
12.0%
110/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Gastrointestinal disorders
Nausea
|
22.2%
203/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
13.8%
127/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.2%
231/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
12.9%
119/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.8%
35/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
6.2%
57/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
Gastrointestinal disorders
Vomiting
|
9.7%
89/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
7.9%
73/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
|
General disorders
Edema limbs
|
1.9%
17/915 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
5.9%
54/920 • Assessed before each cycle of chemotherapy, 3-4 weeks after completion of chemotherapy, every 6 months through 5 years and yearly 6-10.
Participants at Risk includes any patient who submitted an AE form. (The toxicity data is only for patients who were randomized to B-49, not to USOR-06-090 or NSABP B-46.) For All Cause Mortality, deaths were assessed for randomized patients with follow-up.
|
Additional Information
Director, Department of Regulatory Affairs
NRG Oncololgy
Phone: 412-339-5261
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60