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Therapy With Bevacizumab (BEV), Epirubicin, and Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and BEV Given as Neoadjuvant or Adjuvant Therapy for Women With Locally Advanced HER2 Positive Invasive Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00464646
Recruitment Status : Completed
First Posted : April 23, 2007
Results First Posted : September 26, 2012
Last Update Posted : July 25, 2014
Sponsor:
Collaborators:
Genentech, Inc.
International Drug Development Institute
Information provided by (Responsible Party):
NSABP Foundation Inc

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Interventions Drug: Epirubicin
Drug: Cyclophosphamide
Drug: Docetaxel
Drug: Trastuzumab
Drug: Bevacizumab
Enrollment 105
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description • Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC) • Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
Period Title: Overall Study
Started 76 29
Completed 76 29
Not Completed 0 0
Arm/Group Title Cohort A Cohort B Total
Hide Arm/Group Description • Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC) • Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer Total of all reporting groups
Overall Number of Baseline Participants 76 29 105
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 76 participants 29 participants 105 participants
48.1  (9.6) 53.8  (11.4) 49.7  (10.4)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 29 participants 105 participants
18 to less than 50 years 39 10 49
>=50 years and <=59 years 27 8 35
> 59 years 10 11 21
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 76 participants 29 participants 105 participants
Female
76
 100.0%
29
 100.0%
105
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 29 participants 105 participants
White 65 26 91
Black or African American 10 3 13
Native Hawaiian or other Pacific Islander 0 0 0
American Indian or Alaskan Native 0 0 0
Asian 1 0 1
Unknown 0 0 0
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 76 participants 29 participants 105 participants
Hispanic or Latino 2 0 2
Not Hispanic or Latino 70 29 99
Unknown 4 0 4
1.Primary Outcome
Title Number of Patients With Pathological Complete Response (pCR) in the Breast and Nodes for Patients With HER2-positive LABC Following Neoadjuvant Treatment (Cohort A)
Hide Description The determination of pCR is performed by the local pathologist following examination of tissue (breast and nodes)removed at the time of surgery. The outcome measure is the number of participants with no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or SNs identified after neoadjuvant chemotherapy.
Time Frame Assessed at time of surgery on average at 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
73 of the 76 patients in Cohort A were analyzed: 2 patients did not have surgery and 1 patient did not have the nodal status determined.
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description:
• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
Overall Number of Participants Analyzed 73 0
Measure Type: Number
Unit of Measure: participants
34
2.Primary Outcome
Title Cardiac Event Rate as Determined by LVEF Assessment
Hide Description [Not Specified]
Time Frame Cohort A: Baseline, post-treatment with EC, 2-4 weeks after surgery, and 9, 12, 15, and 18 months from study entry. Cohort B: Baseline, post-treatment with EC, 2-3 weeks after the last dose of docetaxel, and 6, 9, 12, 15, and 18 months from study entry.
Outcome Measure Data Not Reported
3.Secondary Outcome
Title pCR in the Breast (Cohort A)
Hide Description [Not Specified]
Time Frame Assessed at the time of surgery
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Clinical Complete Response (cCR)
Hide Description [Not Specified]
Time Frame Determined at baseline, between EC and docetaxel, and following docetaxel (before surgery)
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Grade 3 and 4 Toxicities, Including Toxicities Associated With Radiation Therapy(RT)
Hide Description [Not Specified]
Time Frame Before each cycle of pre-op Rx; 2-4 wks after the last docetaxel dose; 2-4 wks post surgery (Cohort A); every 6 wks during post-op Rx (Cohort A); every 6 wks during targeted therapy alone (Cohort B); RT complications assessed at 12 mos from study entry
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Recurrence-free Survival
Hide Description [Not Specified]
Time Frame From the first dose of study therapy until the date of recurrence or for a maximum of five (5) years from study entry
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame From the first dose of study therapy until the date of death or for a maximum of five (5) years from study entry
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Percentage of Surgical Complications (From Mastectomy, Lumpectomy, and Axillary Staging Procedures) (Cohort A)
Hide Description [Not Specified]
Time Frame 2-4 weeks after surgery and at 9 and 12 months from study entry
Outcome Measure Data Not Reported
Time Frame 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cohort A Cohort B
Hide Arm/Group Description • Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC) • Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
All-Cause Mortality
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   16/76 (21.05%)   5/29 (17.24%) 
Blood and lymphatic system disorders     
Hemoglobin   0/76 (0.00%)  1/29 (3.45%) 
Cardiac disorders     
Left ventricular systolic function   1/76 (1.32%)  0/29 (0.00%) 
Hypertension   0/76 (0.00%)  1/29 (3.45%) 
Gastrointestinal disorders     
Dehydration   1/76 (1.32%)  1/29 (3.45%) 
Diarrhea   1/76 (1.32%)  0/29 (0.00%) 
Hemorrhage, GI - stomach   0/76 (0.00%)  1/29 (3.45%) 
Perforation, GI - colon   1/76 (1.32%)  0/29 (0.00%) 
Ulcer, GI - stomach   0/76 (0.00%)  1/29 (3.45%) 
General disorders     
Pain- head/headache   3/76 (3.95%)  0/29 (0.00%) 
Pain- back   2/76 (2.63%)  0/29 (0.00%) 
Pain- extremity-limb   1/76 (1.32%)  0/29 (0.00%) 
Pain- joint   1/76 (1.32%)  0/29 (0.00%) 
Pain- NOS   1/76 (1.32%)  0/29 (0.00%) 
Pain- chest/thorax   0/76 (0.00%)  1/29 (3.45%) 
Syncope   2/76 (2.63%)  1/29 (3.45%) 
Pain - neck   2/76 (2.63%)  0/29 (0.00%) 
Myositis   1/76 (1.32%)  0/29 (0.00%) 
Infections and infestations     
Infection with normal ANC - skin (cellulites)   2/76 (2.63%)  1/29 (3.45%) 
Infection with Normal ANC - bladder (urinary)   1/76 (1.32%)  0/29 (0.00%) 
Infection documented clinically or micro with grade 4 neutrophils - blood   1/76 (1.32%)  0/29 (0.00%) 
Infection with unknown ANC - wound   1/76 (1.32%)  0/29 (0.00%) 
Infection other - colon   1/76 (1.32%)  0/29 (0.00%) 
Infection other - skin (cellulitis)   1/76 (1.32%)  0/29 (0.00%) 
Investigations     
Hypertriglyceridemia   1/76 (1.32%)  0/29 (0.00%) 
Metabolism and nutrition disorders     
Creatinine   1/76 (1.32%)  0/29 (0.00%) 
Hyponatremia   1/76 (1.32%)  0/29 (0.00%) 
Hypokalemia   0/76 (0.00%)  1/29 (3.45%) 
Musculoskeletal and connective tissue disorders     
Fracture   1/76 (1.32%)  0/29 (0.00%) 
Nervous system disorders     
Neuropathy   1/76 (1.32%)  0/29 (0.00%) 
Neurology - other - loss of consciousness   1/76 (1.32%)  0/29 (0.00%) 
Psychiatric disorders     
Mood alteration - depression   2/76 (2.63%)  0/29 (0.00%) 
Renal and urinary disorders     
Renal failure   1/76 (1.32%)  0/29 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Hemorrhage pulmonary - nose   0/76 (0.00%)  1/29 (3.45%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cohort A Cohort B
Affected / at Risk (%) Affected / at Risk (%)
Total   76/76 (100.00%)   29/29 (100.00%) 
Blood and lymphatic system disorders     
Neutrophils   19/76 (25.00%)  5/29 (17.24%) 
Leucocytes   17/76 (22.37%)  3/29 (10.34%) 
Hemoglobin   10/76 (13.16%)  7/29 (24.14%) 
Lymphopenia   12/76 (15.79%)  7/29 (24.14%) 
Blood - Other (low HCT)   4/76 (5.26%)  0/29 (0.00%) 
Cardiac disorders     
Hypertension   29/76 (38.16%)  12/29 (41.38%) 
Left ventricular systolic function   13/76 (17.11%)  3/29 (10.34%) 
Ear and labyrinth disorders     
Tinnitus   5/76 (6.58%)  1/29 (3.45%) 
Eye disorders     
Watery eye   5/76 (6.58%)  6/29 (20.69%) 
Blurred vision   2/76 (2.63%)  3/29 (10.34%) 
Gastrointestinal disorders     
Mucositis (functional/symptomatic) - oral cavity   31/76 (40.79%)  8/29 (27.59%) 
Vomiting   24/76 (31.58%)  7/29 (24.14%) 
Diarrhea   17/76 (22.37%)  6/29 (20.69%) 
Dehydration   15/76 (19.74%)  7/29 (24.14%) 
Constipation   10/76 (13.16%)  1/29 (3.45%) 
Heartburn   9/76 (11.84%)  2/29 (6.90%) 
Mucositis (clinical exam) - oral cavity   14/76 (18.42%)  5/29 (17.24%) 
Taste alteration   12/76 (15.79%)  4/29 (13.79%) 
Gastritis   6/76 (7.89%)  0/29 (0.00%) 
Esophagitis   4/76 (5.26%)  1/29 (3.45%) 
Hemorhoids   1/76 (1.32%)  5/29 (17.24%) 
General disorders     
Pain - muscle   28/76 (36.84%)  11/29 (37.93%) 
Pain - bone   25/76 (32.89%)  14/29 (48.28%) 
Pain - joint   19/76 (25.00%)  12/29 (41.38%) 
Pain - head/headache   19/76 (25.00%)  6/29 (20.69%) 
Pain - extremity - limb   16/76 (21.05%)  4/29 (13.79%) 
Pain - chest/thorax   11/76 (14.47%)  2/29 (6.90%) 
Pain - breast   9/76 (11.84%)  1/29 (3.45%) 
Pain - back   8/76 (10.53%)  6/29 (20.69%) 
Pain - abdominal NOS   8/76 (10.53%)  2/29 (6.90%) 
Pain - pain NOS   5/76 (6.58%)  6/29 (20.69%) 
Nausea   23/76 (30.26%)  12/29 (41.38%) 
Fatigue   47/76 (61.84%)  20/29 (68.97%) 
Fever   4/76 (5.26%)  1/29 (3.45%) 
Hot flashes   15/76 (19.74%)  4/29 (13.79%) 
Anorexia   12/76 (15.79%)  5/29 (17.24%) 
Insomnia   10/76 (13.16%)  3/29 (10.34%) 
Edema - limb   6/76 (7.89%)  1/29 (3.45%) 
Weight loss   5/76 (6.58%)  3/29 (10.34%) 
Infections and infestations     
Infection with normal ANC - skin (cellulites)   11/76 (14.47%)  1/29 (3.45%) 
Infection with normal ANC - bladder (urinary)   6/76 (7.89%)  6/29 (20.69%) 
Febrile neutropenia   4/76 (5.26%)  3/29 (10.34%) 
Infection with normal ANC - sinus   5/76 (6.58%)  0/29 (0.00%) 
Infection with unknown ANC - sinus   5/76 (6.58%)  0/29 (0.00%) 
Infection with unknown ANC - upper airway NOS   5/76 (6.58%)  0/29 (0.00%) 
Infection with normal ANC - upper airway NOS   3/76 (3.95%)  2/29 (6.90%) 
Infection with unknown ANC - bronchus   3/76 (3.95%)  2/29 (6.90%) 
Infection - other- shingles   1/76 (1.32%)  2/29 (6.90%) 
Investigations     
Hyperglycemia   5/76 (6.58%)  1/29 (3.45%) 
Metabolism and nutrition disorders     
ALT   4/76 (5.26%)  1/29 (3.45%) 
AST, SGOT   4/76 (5.26%)  1/29 (3.45%) 
Hyponatremia   2/76 (2.63%)  2/29 (6.90%) 
Nervous system disorders     
Neuropathy - sensory   18/76 (23.68%)  8/29 (27.59%) 
Dizziness   6/76 (7.89%)  1/29 (3.45%) 
Neuropathy - motor   5/76 (6.58%)  1/29 (3.45%) 
Psychiatric disorders     
Mood alteration - depression   11/76 (14.47%)  5/29 (17.24%) 
Mood alteration - anxiety   9/76 (11.84%)  1/29 (3.45%) 
Reproductive system and breast disorders     
Vaginitis   2/76 (2.63%)  2/29 (6.90%) 
Respiratory, thoracic and mediastinal disorders     
Cough   9/76 (11.84%)  3/29 (10.34%) 
Dyspnea   5/76 (6.58%)  1/29 (3.45%) 
Rhinitis   9/76 (11.84%)  2/29 (6.90%) 
Skin and subcutaneous tissue disorders     
Alopecia   65/76 (85.53%)  24/29 (82.76%) 
Rash   13/76 (17.11%)  9/29 (31.03%) 
Hand - foot   9/76 (11.84%)  2/29 (6.90%) 
Nail Changes   16/76 (21.05%)  9/29 (31.03%) 
Pruritus   4/76 (5.26%)  1/29 (3.45%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Diana Gosik
Organization: NSABP Foundation, Inc.
Phone: 412-339-5333
EMail: diana.gosik@nsabp.org
Layout table for additonal information
Responsible Party: NSABP Foundation Inc
ClinicalTrials.gov Identifier: NCT00464646    
Other Study ID Numbers: NSABP FB-5
First Submitted: April 19, 2007
First Posted: April 23, 2007
Results First Submitted: August 24, 2012
Results First Posted: September 26, 2012
Last Update Posted: July 25, 2014