Trial Outcomes & Findings for Combination Chemotherapy and Filgrastim Before Surgery in Treating Patients With HER2-Positive Breast Cancer That Can Be Removed By Surgery (NCT NCT00194779)
NCT ID: NCT00194779
Last Updated: 2018-03-12
Results Overview
Microscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer \>= 1 cm. Count of participants with either a pCR or mCR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Up to 16 weeks
Results posted on
2018-03-12
Participant Flow
Participant milestones
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age data is missing from 5 patients
Baseline characteristics by cohort
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=50 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
47 years
n=45 Participants • Age data is missing from 5 patients
|
|
Sex: Female, Male
Female
|
50 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=50 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=50 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=50 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=50 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=50 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Up to 16 weeksMicroscopic pCR: No evidence of microscopic invasive tumor at the primary site or in the regional lymph nodes at the time of definitive surgical resection. mCR: The examining pathologist cannot identify gross residual tumor mass in the surgical specimen. This differs from a pCR where the specimen must also be negative for invasive tumor by microscopy. For this study, we are using a definition of mCR that will make the trial more translatable to other institutions. For this study, mCR will be defined as no focus of invasive cancer \>= 1 cm. Count of participants with either a pCR or mCR.
Outcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=42 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Combined Rate of Microscopic pCR and Macroscopic Pathologic Complete Response (mCR)
|
29 Participants
|
SECONDARY outcome
Timeframe: From the initiation of study treatments to 30 days after the end of neoadjuvant treatment or adjuvant treatment if receivedOutcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=46 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Number and Percent of Patients Reporting Grade 2, 3, 4, or Fatal Toxicities of These Regimens, Need for Dose Reduction, or Treatment Interruption or Discontinuation
|
32 Participants
|
SECONDARY outcome
Timeframe: After completion of neoadjuvant therapyPopulation: Due to lack of funding, none of the tissue specimens from participants were tested for EGFR, AR, P53 and Topo2alpha expression, as originally intended by the protocol.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 8 yearsCount of patients that relapsed.
Outcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=31 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Relapse Rate in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed by Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy
|
7 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsMedian time to progression free survival.
Outcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=31 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Time to Progression
|
NA months
Median progression-free survival time was not reached because there were too few events (relapses/deaths).
|
SECONDARY outcome
Timeframe: 1, 2, and 5 yearsKaplan-Meier estimate of overall survival, assessed at 1, 2, and 5 years.
Outcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=31 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN
1 year
|
1 survival probability
Interval 1.0 to 1.0
|
|
OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN
2 years
|
.94 survival probability
Interval 0.85 to 1.0
|
|
OS in Patients With Operable Breast Cancer Treated With Neoadjuvant Chemotherapy for 12 Weeks Followed Weekly Paclitaxel for 12 Weeks and Adjuvant Chemotherapy With XMN
5 years
|
.90 survival probability
Interval 0.81 to 1.0
|
SECONDARY outcome
Timeframe: 1, 2, and 5 yearsKaplan-Meier estimate of disease-free survival, assessed at 1, 2, and 5 years.
Outcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=31 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Disease-free Survival
1 year
|
.97 disease-free survival probability
Interval 0.91 to 1.0
|
|
Disease-free Survival
2 years
|
.90 disease-free survival probability
Interval 0.81 to 1.0
|
|
Disease-free Survival
5 years
|
.84 disease-free survival probability
Interval 0.72 to 0.98
|
SECONDARY outcome
Timeframe: Up to 12 weeksOutcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=47 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Clinical Response to Neoadjuvant Therapy
CR
|
6 Participants
|
|
Clinical Response to Neoadjuvant Therapy
PR
|
33 Participants
|
|
Clinical Response to Neoadjuvant Therapy
SD
|
6 Participants
|
|
Clinical Response to Neoadjuvant Therapy
ND
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 24 weeksOutcome measures
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=45 Participants
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Clinical Response to Paclitaxel
CR
|
23 Participants
|
|
Clinical Response to Paclitaxel
PR
|
14 Participants
|
|
Clinical Response to Paclitaxel
SD
|
4 Participants
|
|
Clinical Response to Paclitaxel
ND
|
3 Participants
|
|
Clinical Response to Paclitaxel
Progression
|
1 Participants
|
Adverse Events
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
Serious events: 8 serious events
Other events: 40 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=50 participants at risk
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.0%
1/50
|
|
Psychiatric disorders
Depression
|
2.0%
1/50
|
|
Investigations
Neutropenia
|
10.0%
5/50
|
|
General disorders
Death
|
2.0%
1/50
|
Other adverse events
| Measure |
Treatment (Neoadjuvant Therapy, Adjuvant Therapy)
n=50 participants at risk
See Detailed Description.
doxorubicin hydrochloride: Given IV
cyclophosphamide: Given PO
paclitaxel: Given IV
filgrastim: Given SC
capecitabine: Given PO
methotrexate: Given IV
vinorelbine tartrate: Given IV
needle biopsy: Correlative studies
therapeutic conventional surgery: Undergo definitive breast surgery
immunohistochemistry staining method: Correlative studies
trastuzumab: Given IV
tamoxifen citrate: Given PO
letrozole: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Blood and lymphatic system disorders
Leukocytes Decreased
|
64.0%
32/50
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
8.0%
4/50
|
|
Blood and lymphatic system disorders
Numbness (lymphs)
|
64.0%
32/50
|
|
Blood and lymphatic system disorders
Pain (lymphs)
|
58.0%
29/50
|
|
Cardiac disorders
Pain (chest)
|
24.0%
12/50
|
|
Cardiac disorders
Palpitations
|
58.0%
29/50
|
|
Cardiac disorders
Tachycardia
|
22.0%
11/50
|
|
Ear and labyrinth disorders
Clear Drainage (ear)
|
40.0%
20/50
|
|
Eye disorders
Blurred Vision
|
38.0%
19/50
|
|
Eye disorders
Dry Eyes
|
52.0%
26/50
|
|
Eye disorders
Swollen Eyes
|
32.0%
16/50
|
|
Eye disorders
Watery Eyes
|
14.0%
7/50
|
|
Gastrointestinal disorders
Constipation
|
56.0%
28/50
|
|
Gastrointestinal disorders
Cramping
|
6.0%
3/50
|
|
Gastrointestinal disorders
Diarrhea
|
24.0%
12/50
|
|
Gastrointestinal disorders
Dry Mouth
|
40.0%
20/50
|
|
Gastrointestinal disorders
Dysgeusia
|
30.0%
15/50
|
|
Gastrointestinal disorders
Dysphagia
|
20.0%
10/50
|
|
Gastrointestinal disorders
Esophagitis
|
28.0%
14/50
|
|
Gastrointestinal disorders
Flatulence
|
18.0%
9/50
|
|
Gastrointestinal disorders
Bleeding gums (while brushing)
|
8.0%
4/50
|
|
Gastrointestinal disorders
Heartburn
|
24.0%
12/50
|
|
Gastrointestinal disorders
Irritable Bowel Syndrome
|
12.0%
6/50
|
|
Gastrointestinal disorders
Metallic taste
|
20.0%
10/50
|
|
Gastrointestinal disorders
Mucositis (oral/stomatitis)
|
62.0%
31/50
|
|
Gastrointestinal disorders
Nausea
|
18.0%
9/50
|
|
Gastrointestinal disorders
Oral Herpes
|
8.0%
4/50
|
|
Gastrointestinal disorders
Pain (teeth)
|
6.0%
3/50
|
|
Gastrointestinal disorders
Reflux
|
10.0%
5/50
|
|
Gastrointestinal disorders
Stomach Flu
|
26.0%
13/50
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
7/50
|
|
General disorders
Alopecia
|
14.0%
7/50
|
|
General disorders
Fatigue
|
24.0%
12/50
|
|
General disorders
Hot flashes
|
6.0%
3/50
|
|
General disorders
Pain
|
6.0%
3/50
|
|
General disorders
Pain (bone)
|
10.0%
5/50
|
|
General disorders
Swelling (joints)
|
8.0%
4/50
|
|
General disorders
Weight loss
|
8.0%
4/50
|
|
Immune system disorders
Acute infusion allergic reaction
|
6.0%
3/50
|
|
Infections and infestations
Urinary tract infection
|
8.0%
4/50
|
|
Investigations
Hemoglobin decreased
|
6.0%
3/50
|
|
Investigations
Ion gap decreased
|
58.0%
29/50
|
|
Investigations
Lactate dehydrogenase increased
|
72.0%
36/50
|
|
Investigations
Lymphopenia Decreased
|
16.0%
8/50
|
|
Investigations
Neutrophils Decreased
|
60.0%
30/50
|
|
Investigations
Platelets decreased
|
54.0%
27/50
|
|
Investigations
Platelets increased
|
22.0%
11/50
|
|
Investigations
SGOT increased
|
22.0%
11/50
|
|
Investigations
SGPT increased
|
10.0%
5/50
|
|
Investigations
Urea nitrogen decreased
|
38.0%
19/50
|
|
Investigations
Weight gain
|
48.0%
24/50
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
5/50
|
|
Metabolism and nutrition disorders
Calcium decreased
|
8.0%
4/50
|
|
Metabolism and nutrition disorders
Ferritin increased
|
28.0%
14/50
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.0%
11/50
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.0%
4/50
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.0%
6/50
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.0%
14/50
|
|
Musculoskeletal and connective tissue disorders
Athralgia
|
6.0%
3/50
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
30.0%
15/50
|
|
Musculoskeletal and connective tissue disorders
Pain (joint)
|
18.0%
9/50
|
|
Nervous system disorders
Dizziness
|
6.0%
3/50
|
|
Nervous system disorders
Headache
|
30.0%
15/50
|
|
Nervous system disorders
Paresthesia
|
6.0%
3/50
|
|
Nervous system disorders
Vertigo
|
10.0%
5/50
|
|
Psychiatric disorders
Anxiety
|
18.0%
9/50
|
|
Psychiatric disorders
Chemo brain
|
10.0%
5/50
|
|
Psychiatric disorders
Confusion
|
10.0%
5/50
|
|
Psychiatric disorders
Depression
|
6.0%
3/50
|
|
Psychiatric disorders
Insomnia
|
18.0%
9/50
|
|
Psychiatric disorders
Memory loss
|
8.0%
4/50
|
|
Renal and urinary disorders
Incontinence (urinary)
|
6.0%
3/50
|
|
Reproductive system and breast disorders
Vaginal discharge
|
6.0%
3/50
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.0%
3/50
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
6.0%
3/50
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
6.0%
3/50
|
|
Skin and subcutaneous tissue disorders
Dry sweats
|
8.0%
4/50
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.0%
3/50
|
|
Skin and subcutaneous tissue disorders
Hand foot syndrome
|
16.0%
8/50
|
|
Skin and subcutaneous tissue disorders
Hyperpigmintation
|
8.0%
4/50
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
3/50
|
|
Vascular disorders
Hypotension
|
6.0%
3/50
|
Additional Information
Dr. Hannah Linden
University of Washington / Seattle Cancer Care Alliance
Phone: 206-288-6989
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place