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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT00464646

Run by

NSABP Foundation Inc

People needed

105

Starts

2007-05-01

Expected to finish

2014-05-01

Last updated by the study team

2021-10-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Conditions for eligibility for patients with LABC (Cohort A):
• The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy.
• Patients must have clinical Stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla that is greater than or equal to 2.0 cm measured by clinical exam, unless the patient has inflammatory breast carcinoma, in which case measurable disease is not required.
• Conditions for eligibility for patients with resected Stage III breast cancer (Cohort B)
• Patients must have undergone either a total mastectomy or a lumpectomy.
• Patients must have completed one of the following procedures for evaluation of pathologic nodal status.
• Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes, or
• Axillary lymphadenectomy without SN isolation procedure.
• The interval between the last surgery (for breast cancer treatment or staging) and study entry must be no more than 84 days.
• By pathologic evaluation, ipsilateral nodes must be pN2 or pN3.
• For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and DCIS as determined by the local pathologist. If pathologic examination demonstrates tumor at the line of resection, additional operative procedures may be performed to obtain clear margins. If tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible. (Patients with margins positive for LCIS are eligible without additional resection.)
• For patients who undergo mastectomy, margins must be free of gross residual tumor. Patients with microscopic positive margins are eligible.
• Conditions for patient eligibility (ALL patients)
• The patient must have consented to participate and must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
• Patients must be female.
• The patient must be greater than or equal to 18 years old.
• The patient's ECOG performance status must be 0 or 1.
• The tumor must be invasive adenocarcinoma of the breast on histologic examination.
• The breast cancer must be determined to be HER2-positive prior to study entry. Assays performed using FISH require gene amplification. Assays using IHC require a strongly positive (3+) staining score.
• At the time of study entry, blood counts must meet the following criteria:
• Absolute neutrophil count (ANC) must be greater than/equal to 1200/mm3.
• Platelet count must be greater than/equal to 100,000/mm3.
• Hemoglobin must be greater than/equal to 10 g/dL.
• The following criteria for evidence of adequate hepatic function must be met:
• total bilirubin must be less than/equal to ULN for the lab unless the patient has a grade 1 bilirubin elevation (greater than ULN to 1.5 x ULN) due to Gilbert's disease or similar syndrome involving slow conjugation of bilirubin; and

You may not qualify if…

• Conditions for patient ineligibility (Cohort A)
• FNA alone to diagnose the primary tumor.
• Surgical axillary staging procedure prior to study entry. (Procedures that are permitted include: 1) FNA or core biopsy of an axillary node for any patient, and 2) although not recommended, a pre-neoadjuvant therapy SN biopsy for patients with clinically negative axillary nodes.
• Condition for patient ineligibility (Cohort B)
• Breast reconstruction using tissue expanders or implants at the time of mastectomy.
• Conditions for patient ineligibility (ALL patients)
• Definitive clinical or radiologic evidence of metastatic disease.
• Synchronous bilateral invasive breast cancer.
• History of ipsilateral or contralateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT.
• History of non-breast malignancies within the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin.
• Prior therapy with anthracyclines, taxanes, trastuzumab, or bevacizumab for any malignancy.
• Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry.
• Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. (Patients are eligible if these medications are discontinued prior to study entry.)
• Any sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy, etc. These patients are eligible if this therapy is discontinued prior to study entry. (Women of reproductive potential must agree to use an effective non-hormonal method of contraception during study therapy and for at least 6 months after completion of targeted therapy.)
• Cardiac disease that would preclude the use of the drugs included in the FB-5 treatment regimen. This includes but is not confined to:
• Active cardiac disease: angina pectoris that requires the use of anti-anginal medication; ventricular arrhythmias except for benign premature ventricular contractions controlled by medication; supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; conduction abnormality requiring a pacemaker; and clinically significant valvular disease.
• History of cardiac disease: myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of LV function; documented CHF; or documented cardiomyopathy.
• Uncontrolled hypertension defined as systolic BP greater than 150 mmHg or diastolic BP greater han 90 mmHg, with or without anti-hypertensive medication. Patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria.
• History of hypertensive crisis or hypertensive encephalopathy.
• History of TIA or CVA.
• History of other arterial thrombotic event within 12 months before study entry.
• Symptomatic peripheral vascular disease.
• Any significant bleeding within 6 months before study entry, exclusive of menorrhagia in premenopausal women.
• Serious or non-healing wound, skin ulcers, or bone fracture.
• Gastroduodenal ulcer(s) determined by endoscopy to be active.

Where it is running

• 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

Full record on ClinicalTrials.gov

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