Chemotherapy With or Without Bevacizumab in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer That Can Be Removed By Surgery

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - 120 Years

Healthy Volunteers

Not accepted

Interventions

• bevacizumab — BIOLOGICAL
  15 mg/kg IV
• capecitabine — DRUG
  825 mg/m2 orally
• cyclophosphamide — DRUG
  600 mg/m2 IV
• docetaxel — DRUG
  100 mg/m2 IV
• doxorubicin hydrochloride (Adriamycin) — DRUG
  60 mg/m2 IV
• gemcitabine hydrochloride — DRUG
  1000 mg/m2 IV

Study Details

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer. PURPOSE: This randomized phase III trial is studying six different chemotherapy regimens to compare how well they work with or without bevacizumab in treating women with stage I, stage II, or stage IIIA breast cancer that can be removed by surgery.

Key Dates

First listed

Dec 7, 2006

Start date

Nov 30, 2006

Status verified

Sep 2017

Primary completion

Mar 31, 2011

Completion

Mar 31, 2018

Study Design

Enrollment

1,206 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1A: Docetaxel then AC
  Patients receive docetaxel IV on day 1 every 3 weeks for up to 4 cycles. Patients then receive AC IV every 3 weeks for up to 4 cycles. Patients then undergo surgery (lumpectomy or mastectomy).
• Experimental: Arm 1B Docetaxel + Bev then AC + Bev
  Patients receive bevacizumab (bev) IV on day 1 and docetaxel every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab IV every 3 weeks for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Arm 2A: Docetaxel + Capecitabine then AC
  Patients receive docetaxel as in Arm 1A and oral capecitabine (cape) twice daily on days 1-14 every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.
• Experimental: Arm 2B: Docetaxel + Cape + Bev then AC + Bev
  Patients receive bevacizumab as in Arm 1B and docetaxel and capecitabine as in Arm III. Treatment repeats every 3 weeks for up to 4 cycles. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1B. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.
• Experimental: Arm 3A: Docetaxel + Gem then AC
  Patients receive docetaxel as in Arm 1A and gemcitabine hydrochloride IV on days 1 and 8 of each cycle every 3 weeks for up to 4 cycles. Patients then receive AC as in Arm 1A. Patients then undergo surgery as in Arm 1A.
• Experimental: Arm 3B: Docetaxel + Gem + Bev then AC + Bev
  Patients receive docetaxel as in Arm 1A, gemcitabine hydrochloride as in Arm 3A, and bevacizumab as in Arm 1B. Patients then receive AC every 3 weeks for up to 4 cycles and 2 additional cycles of bevacizumab concurrent with the first 2 cycles of AC. Patients then undergo surgery as in Arm 1A. At least 4-6 weeks after surgery, patients receive adjuvant bevacizumab as in Arm 1B.

Primary Outcome Measure

Pathologic Complete Response (pCR) of the Primary Tumor in the Breast [ Time Frame: Time of surgery, on average 6 or 13 months ]

Locations (432)

Find similar trials in Little Rock, AR

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