OBJECTIVES:

1. Compare the efficacy of bevacizumab with capecitabine vs capecitabine alone in women with previously treated metastatic breast cancer, as measured by time to disease progression, objective response rate, duration of response, 1-year survival, and duration of survival.
2. Compare the safety of these regimens in these patients.
3. Compare the pharmacokinetics of these regimens in a subset of these patients.
4. Determine the pharmacodynamics of bevacizumab with capecitabine in a subset of these patients.
5. Compare the extent of change in quality of life of patients treated with these regimens.

PARTICIPATION CRITERIA

• Age: 18 and over
• Histologically confirmed progressive metastatic breast cancer
• Previously treated with 1-2 conventional chemotherapy regimens for metastatic disease
• Previously treated with both an anthracycline (or anthracenedione) and taxane OR
• No prior chemotherapy for metastatic disease if previously treated with an adjuvant anthracycline (or anthracenedione) and taxane regimen and if relapse occurred within 12 months of completing adjuvant therapy
• Bidimensionally measurable disease
• No HER2-positive disease (3+ by immunohistochemistry or positive by FISH) unless previously relapsed after trastuzumab (Herceptin)

PROTOCOL
Arm I: Oral capecitabine twice daily on days 1-14.
Arm II: Chemotherapy as in Arm I plus bevacizumab IV over 30-90 minutes on day 1.

Treatment repeats in both arms every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity. Patients with progressive disease in arm II may continue to receive bevacizumab alone or in combination with a new chemotherapy regimen or other treatment.

STUDY CONTACT:
Robert Curry, Chair Ph: 650-225-4922
Genentech Inc.

OBJECTIVES:

1. Determine the objective response rate in elderly women with stage IV breast cancer treated with oral vinorelbine.
2. Determine the toxicity profile of this drug in these patients.
3. Determine the time to progression in these patients treated with this drug.
4. Assess these patients’ preferences with re g a rd to this oral drug .
5. Determine the quality of life of these patients treated with this drug.
6. Assess individual variation in responses (toxicity and/or activity), pharmacokinetic parameters, and/or biologic correlates due to genetic differences in enzymes involved in the transport, metabolism, and/or mechanism of action of this drug in these patients.

PARTICIPATION CRITERIA

• Age 65 and over
• Histologically or cytologically confirmed stage IV breast cancer
• Eligible to receive first- or second-line chemotherapy
• Measurable disease: At least 1 lesion that can be accurately measured in at least 1 dimension as at least 20 mm in longest diameter. Must be completely outside prior
  irradiation port unless there is proof of progressive disease after completion of prior radiotherapy

PROTOCOL
Patients receive oral vinorelbine weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

STUDY CONTACT:
Edith A. Perez, Chair Ph: 507-284-5369
North Central Cancer Treatment Group

OBJECTIVES:

1. Compare the objective response rate in elderly women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer.
2. Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens.
3. Compare the safety of these regimens in this patient population.
4. Compare the quality of life of these patients treated with these regimens.

PARTICIPATION CRITERIA

• Age: 65 and over
• Stage IV (M1) disease
• HER2-negative (0,1+, or 2+ by IHC or FISH) or status unknown
• Measurable disease (at least 1 lesion >/= 20 mm in longest diameter or at least 10 mm by spiral CT scan)
• Ineligible if PR or CR to prior hormonal therapy or those with bone-only disease
• More than 6 months since prior adjuvant chemotherapy or taxanes
• Prior taxanes allowed only if administered every 3 weeks

STUDY CONTACTS
Edith A. Perez, Chair Ph: 507-284-5369
Theradex

OBJECTIVES:

1. Compare time to treatment failure in patients with locally recurrent or metastatic breast cancer treated with paclitaxel with or without bevacizumab.
2. Compare the objective response rate, duration of response, and overall survival in patients treated with these regi-mens.
3. Compare the toxicity of these regimens in these patients.
4. Compare the quality of life of patients treated with these regimens.

PARTICIPATION CRITERIA

• Age: 18 and over
• Adenocarcinoma of the breast, locally recurrent disease not amenable to surgical resection, or Metastatic disease • No HER2-overexpressing (3+) breast cancer unless previously treated with trastuzumab
• No CNS metastases
• No prior chemo for locally recurrent or metastatic breast cancer
• At least 12 months since prior adjuvant or neoadjuvant taxane therapy
• At least 3 weeks since prior adjuvant chemotherapy

STUDY CONTACT:
Robert L. Comis, Chair Ph: 215-789-3645
Eastern Cooperative Oncology Group