Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer

Conditions

• Invasive Breast Carcinoma
• Recurrent Breast Carcinoma
• Stage III Breast Cancer AJCC v6
• Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab — BIOLOGICAL
  Given IV
• Laboratory Biomarker Analysis — OTHER
  Correlative studies
• Letrozole — DRUG
  Given PO
• Questionnaire Administration — OTHER
  Ancillary studies
• Tamoxifen Citrate — DRUG
  Given PO

Study Details

This randomized phase III trial studies tamoxifen citrate or letrozole together with bevacizumab to see how well it works compared with tamoxifen citrate or letrozole alone in treating women with stage IIIB or stage IV breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Immunotherapy with monoclonal antibodies, such as bevacizumab, may induce changes in the body's immune system and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving hormone therapy is more effective with or without bevacizumab in treating advanced breast cancer.

Key Dates

First listed

Jan 28, 2008

Start date

Sep 24, 2008

Status verified

May 2025

Primary completion

Jun 30, 2014

Completion

May 1, 2025

Study Design

Enrollment

394 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm I (endocrine therapy with monoclonal antibody)
  Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
• Active Comparator: Arm II (endocrine therapy)
  Patients receive endocrine therapy\* (tamoxifen citrate\* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Progression-free Survival [ Time Frame: From randomization until disease progression or death whichever occurs first, assessed up to 5 years ]

Locations (521)

Find similar trials in Mobile, AL

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