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Spots Global Cancer Trial Database for 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

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Trial Identification

Brief Title: 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

Official Title: A Phase II Clinical Trial of Epirubicin Plus Cyclophosphamide Followed by Docetaxel Plus Trastuzumab and Bevacizumab Given as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or Given as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer

Study ID: NCT00464646

Conditions

Breast Cancer

Study Description

Brief Summary: The main purpose is to learn if adding bevacizumab to standard chemotherapy and trastuzumab to treat HER2-positive breast cancer will affect heart function. This study will evaluate: * How bevacizumab, given with chemotherapy, and then bevacizumab given with trastuzumab after surgery, will affect breast tumors * Side effects from adding bevacizumab to chemotherapy and trastuzumab * Whether adding bevacizumab to chemotherapy and trastuzumab for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery

Detailed Description: NSABP FB-5 is a Phase II study for women with HER2-positive invasive breast cancer evaluating a regimen of epirubicin plus cyclophosphamide followed by docetaxel plus trastuzumab and bevacizumab in two patient cohorts: * 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. The primary aims of the study are to determine the rate of cardiac events for all patients and the pCR rate in the breast and axillary lymph nodes for Cohort A. Cardiac events will be defined as NYHA Class III/IV congestive heart failure and cardiac death. For Cohort A, secondary aims of the study include determining the rate of pCR in the breast and the cCR rate following the neoadjuvant therapy. The secondary aims also include determining the value of the regimen in improving 5-year RFS and 5-year OS and determining the non-cardiac toxicities of the regimen in all patients. Patients in Cohort A will receive neoadjuvant therapy consisting of epirubicin plus cyclophosphamide (EC) every 21 days for 4 cycles plus bevacizumab given on Day 1 of Cycle 4 only, followed by docetaxel every 21 days for 4 cycles plus bevacizumab every 21 days for the initial 3 cycles. Patients will also receive weekly trastuzumab beginning with the first cycle of docetaxel and continuing until 1-7 days before surgery. Patients will then have breast surgery (lumpectomy or mastectomy) with axillary staging. Approximately 4-6 weeks following surgery, bevacizumab and trastuzumab will resume and continue every 3 weeks for 13 doses to complete one year of targeted therapy. Patients in Cohort B will receive adjuvant therapy consisting of EC every 21 days for 4 cycles followed by docetaxel every 21 days for 4 cycles. Beginning with the first cycle of docetaxel, patients will also receive bevacizumab every 21 days for 4 cycles and weekly trastuzumab until 3 weeks after the last docetaxel dose. Beginning 3 weeks after the last dose of docetaxel, both bevacizumab and trastuzumab will then be given every 3 weeks for 13 doses to complete 1 year of targeted therapy. Cardiac monitoring will be conducted for both cohorts. For Cohort A, LVEF assessments will be conducted at baseline, post-EC, 2-4 weeks following surgery (about 6 months from study entry), and 9, 12, 15, and 18 months from study entry. For Cohort B, LVEF assessments will be conducted at baseline, post-EC, and 6, 9, 12, 15, and 18 months from study entry. The preferred method for LVEF assessment is 2-D echocardiogram; however, LVEF assessment by MUGA scan is permitted. Patient follow-up will continue for 5 years following study entry. The FB-5 sample size is 105 patients.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Clearview Cancer Institute- Huntsville, Huntsville, Alabama, United States

Kaiser Permanente-San Diego, San Diego, California, United States

Kaiser Permanente-Vallejo, Vallejo, California, United States

CCOP, Colorado Cancer Research Program, Inc., Denver, Colorado, United States

Baptist Regional Cancer Institute, Jacksonville, Florida, United States

Rush University Medical Center, Chicago, Illinois, United States

CCOP, Central Illinois, Springfield, Illinois, United States

CCOP, Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States

University of Iowa, Iowa City, Iowa, United States

NortonHealtcare Inc., Louisville, Kentucky, United States

CCOP, Grand Rapids Clnical Oncology Program, Grand Rapids, Michigan, United States

CCOP, Michigan Cancer Research Consortium, Grosse Pointe Woods, Michigan, United States

CCOP, Kalamazoo, MI, Kalamazoo, Michigan, United States

Michigan State University - Breslin Cancer Center, Lansing, Michigan, United States

CCOP, Metro-Minnesota, Minneapolis, Minnesota, United States

CCOP, Cancer Research for the Ozarks, Springfield, Missouri, United States

Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

University Hospital and Medical Center - SUNY, Stony Brook, New York, United States

CCOP, Southeast Cancer Control Consortium, Charlotte, North Carolina, United States

East Carolina University, Greenville, North Carolina, United States

Aultman Hospital, Canton, Ohio, United States

Case Western Reserve/University Hospitals-Ireland Cancer Cntr., Cleveland, Ohio, United States

CCOP, Dayton, OH, Dayton, Ohio, United States

CCOP, Columbia River Oncology, Portland, Oregon, United States

Kimmel Cancer Center at Jefferson, Philadelphia, Pennsylvania, United States

Albert Einstein Healthcare Network, Philadelphia, Pennsylvania, United States

Allegheny General Hospital/Allegheny-Singer Research Institute, Pittsburgh, Pennsylvania, United States

NSABP Foundation, Inc., Pittsburgh, Pennsylvania, United States

University of Pittsburgh, Pittsburgh, Pennsylvania, United States

Mercy Hospital, Scranton, Pennsylvania, United States

CCOP, Upstate Carolina, Spartanburg, South Carolina, United States

Joe Arrington Cancer Research & Treatment Center, Lubbock, Texas, United States

CCOP, Scott and White Memorial Hospital, Temple, Texas, United States

MBCCOP, Virginia Commonwealth University, Richmond, Virginia, United States

CCOP, Marshfield Clinic, Marshfield, Wisconsin, United States

University of Montreal Hospital Group, Montreal, Quebec, Canada

Contact Details

Name: Norman Wolmark, MD

Affiliation: NSABP Foundation Inc

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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