Trial Outcomes & Findings for Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer (NCT NCT00544167)
NCT ID: NCT00544167
Last Updated: 2013-04-01
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
18 Months
Results posted on
2013-04-01
Participant Flow
Participant milestones
| Measure |
Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib
All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
|
|---|---|
|
Overall Study
STARTED
|
45
|
|
Overall Study
COMPLETED
|
16
|
|
Overall Study
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib
All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
|
|---|---|
|
Overall Study
Adverse Event
|
21
|
|
Overall Study
Physician Decision
|
8
|
Baseline Characteristics
Adjuvant Doxorubicin/Cyclophosphamide and Paclitaxel Plus Sorafenib Breast Cancer
Baseline characteristics by cohort
| Measure |
Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib
n=45 Participants
Doxorubicin 60mg/m2 IV, Cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 12 weeks followed by 12 weeks of paclitaxel (either 175mg/m2 IV every three weeks or 80mg/m2 IV weekly) and sorafenib 400mg twice daily by mouth (up to a maximum of 1 year).
|
|---|---|
|
Age Continuous
|
54 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 18 MonthsOutcome measures
| Measure |
Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib
n=45 Participants
|
|---|---|
|
The Safety and Tolerability of Protocol Treatment, Defined as the Percentage of Patients Experiencing Severe or Life-threatening Side Effects Per CTCAE Version 3.0.
|
40 percentage of patients
|
Adverse Events
Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib
n=45 participants at risk
All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
|
|---|---|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.2%
1/45 • Number of events 1
|
|
Hepatobiliary disorders
Pancreatitis
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Infection - pneumonia
|
2.2%
1/45 • Number of events 1
|
|
Reproductive system and breast disorders
Abcess of Bartholin's cyst
|
2.2%
1/45 • Number of events 1
|
|
Gastrointestinal disorders
Hemmorhage - GI
|
2.2%
1/45 • Number of events 1
|
|
Infections and infestations
Infection - Streptococcus
|
2.2%
1/45 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.2%
1/45 • Number of events 1
|
|
Cardiac disorders
Ventricular arrhythmia - left ventricular systolic dysfunction
|
2.2%
1/45 • Number of events 1
|
Other adverse events
| Measure |
Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib
n=45 participants at risk
All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
|
|---|---|
|
Gastrointestinal disorders
Pain - Abdomen
|
22.2%
10/45 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
68.9%
31/45 • Number of events 158
|
|
Gastrointestinal disorders
Anorexia
|
24.4%
11/45 • Number of events 39
|
|
Psychiatric disorders
Mood Alteration - Anxiety
|
17.8%
8/45 • Number of events 26
|
|
Musculoskeletal and connective tissue disorders
Pain - Joint
|
42.2%
19/45 • Number of events 47
|
|
Cardiac disorders
Superventricular arrhythmia - Atrial Fibrillation
|
15.6%
7/45 • Number of events 12
|
|
Eye disorders
Blurred Vision
|
11.1%
5/45 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
Nasal/Paranasal Reactions
|
6.7%
3/45 • Number of events 3
|
|
Gastrointestinal disorders
Constipation
|
31.1%
14/45 • Number of events 40
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
10/45 • Number of events 19
|
|
Psychiatric disorders
Mood Alteration - Depression
|
11.1%
5/45 • Number of events 18
|
|
Gastrointestinal disorders
Diarrhea
|
37.8%
17/45 • Number of events 55
|
|
Nervous system disorders
Dizziness
|
13.3%
6/45 • Number of events 6
|
|
Gastrointestinal disorders
Dry Mouth
|
6.7%
3/45 • Number of events 8
|
|
Gastrointestinal disorders
Taste Alteration
|
24.4%
11/45 • Number of events 58
|
|
Gastrointestinal disorders
Heartburn
|
8.9%
4/45 • Number of events 10
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
3/45 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.2%
10/45 • Number of events 23
|
|
Blood and lymphatic system disorders
Edema
|
8.9%
4/45 • Number of events 13
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage Pulmonary - Nose
|
13.3%
6/45 • Number of events 12
|
|
Gastrointestinal disorders
Esophagitis
|
6.7%
3/45 • Number of events 11
|
|
General disorders
Fatigue
|
88.9%
40/45 • Number of events 228
|
|
General disorders
Fever
|
24.4%
11/45 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Hand-Foot
|
28.9%
13/45 • Number of events 54
|
|
Blood and lymphatic system disorders
Hemoglobin
|
93.3%
42/45 • Number of events 169
|
|
Endocrine disorders
Hot Flashes
|
17.8%
8/45 • Number of events 13
|
|
Endocrine disorders
Hyperglycemia
|
11.1%
5/45 • Number of events 27
|
|
Cardiac disorders
Hypertension
|
20.0%
9/45 • Number of events 22
|
|
Endocrine disorders
Hypokalemia
|
8.9%
4/45 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Infection - URI
|
8.9%
4/45 • Number of events 4
|
|
Infections and infestations
Infection
|
15.6%
7/45 • Number of events 10
|
|
General disorders
Insomnia
|
15.6%
7/45 • Number of events 10
|
|
Cardiac disorders
Left Ventricular Systolic Dysfunction
|
8.9%
4/45 • Number of events 5
|
|
Eye disorders
Watery Eye
|
8.9%
4/45 • Number of events 28
|
|
Blood and lymphatic system disorders
Leukocytes
|
82.2%
37/45 • Number of events 161
|
|
Gastrointestinal disorders
Mouth Sore
|
8.9%
4/45 • Number of events 9
|
|
Gastrointestinal disorders
Muscositis - Oral Cavity
|
44.4%
20/45 • Number of events 55
|
|
Musculoskeletal and connective tissue disorders
Pain - Muscle
|
48.9%
22/45 • Number of events 47
|
|
Skin and subcutaneous tissue disorders
Nail Changes
|
8.9%
4/45 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
88.9%
40/45 • Number of events 125
|
|
Nervous system disorders
Neuropathy - Peripheral
|
8.9%
4/45 • Number of events 23
|
|
Nervous system disorders
Neuropathy - Sensory
|
62.2%
28/45 • Number of events 89
|
|
Blood and lymphatic system disorders
Neutrophils
|
75.6%
34/45 • Number of events 111
|
|
Musculoskeletal and connective tissue disorders
Pain - Bone
|
22.2%
10/45 • Number of events 16
|
|
Ear and labyrinth disorders
Pain - Ear
|
6.7%
3/45 • Number of events 3
|
|
General disorders
Pain - Headache
|
20.0%
9/45 • Number of events 12
|
|
Infections and infestations
Infection - Pharynx
|
6.7%
3/45 • Number of events 4
|
|
Blood and lymphatic system disorders
Platelets
|
37.8%
17/45 • Number of events 37
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
8.9%
4/45 • Number of events 17
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
20.0%
9/45 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Rash
|
57.8%
26/45 • Number of events 88
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
15.6%
7/45 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
8.9%
4/45 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pain - Throat
|
13.3%
6/45 • Number of events 11
|
|
Cardiac disorders
Tachycardia
|
17.8%
8/45 • Number of events 16
|
|
Gastrointestinal disorders
Vomiting
|
46.7%
21/45 • Number of events 53
|
|
General disorders
Weakness
|
6.7%
3/45 • Number of events 12
|
|
General disorders
Weight Loss
|
8.9%
4/45 • Number of events 9
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review/embargo results communications prior to public release for a period that is \>60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
- Publication restrictions are in place
Restriction type: OTHER