Phase II Bevacizumab + Tax In Advanced Breast Cancer

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as bevacizumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or deliver cancer-killing substances to them. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This randomized phase II trial is to see if docetaxel with or without bevacizumab followed by surgery, radiation therapy, and combination chemotherapy works better in treating patients who have stage III or stage IV breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Bevacizumab; Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Stage IIIA or IIIB

• Stage IV if patient has clinical evidence of locally advanced breast cancer only

• Inoperable disease

• Prior carcinoma in situ of the breast or bilateral breast cancer is allowed

• No CNS metastases

• Hormone receptor status:

• Estrogen and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female or male

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2 OR

• Karnofsky 60-100%

Life expectancy:

• More than 6 months

Hematopoietic:

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin normal (no greater than 2 times upper limit of normal [ULN] in patients with an inherited disorder)

• AST/ALT no greater than 2.5 times ULN

• INR and PTT normal

Renal:

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

• No proteinuria or clinically significant renal impairment

Cardiovascular:

• LVEF at least 45% by echocardiogram or MUGA scan

• No New York Heart Association class III or IV heart disease

• No symptomatic congestive heart failure

• No unstable angina pectoris

• No cardiac arrhythmia

• No inadequately controlled hypertension

• No history of deep vein thrombosis or other thromboses

• No clinically significant peripheral artery disease

• No arterial thromboembolic event within the past 6 months including the following:

• Transient ischemic attack

• Cerebrovascular accident

• Myocardial infarction

Other:

• No other prior or concurrent malignancy within the past 10 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix

• No other uncontrolled concurrent illness

• No ongoing or active infection

• No non-healing wounds

• No psychiatric illness or social situation that would preclude study participation

• No prior allergic reaction to compounds of similar chemical or biological composition to bevacizumab, docetaxel, polysorbate 80 (Tween) formulations, or other agents used in this study

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No concurrent cytokines during docetaxel/bevacizumab administration

• Concurrent cytokines during doxorubicin/cyclophosphamide administration allowed at the discretion of the treating physician

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Prior hormonal therapy (e.g., tamoxifen) allowed

Radiotherapy:

• Prior radiotherapy to affected breast allowed

Surgery:

• More than 28 days since prior major surgery

Other:

• At least 10 days since prior thrombolytic agents

• At least 10 days since prior full-dose oral or parenteral anticoagulants except to maintain patency of permanent indwelling IV catheters

• Concurrent warfarin allowed provided INR is less than 1.5

• Concurrent bisphosphonates allowed for osseous metastases provided they are not initiated on day 1 of cycle 1

• No concurrent combination antiretroviral therapy for HIV-positive patients

• No concurrent full-dose oral or parenteral anticoagulants except to maintain patency of permanent indwelling IV catheters

• No concurrent thrombolytic agents

• No other concurrent anticancer agents or therapies

• No other concurrent investigational agents