Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: The monoclonal antibody trastuzumab can locate breast cancer cells that have HER2 on their surface and either kill them or deliver tumor-killing substances to them without harming normal cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. Combining trastuzumab with exemestane may be an effective treatment for breast cancer with high amounts of HER2. PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab with exemestane in treating postmenopausal women who have metastatic or locally advanced HER2-positive breast cancer.

Detailed Description
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OBJECTIVES: Determine the efficacy of exemestane and trastuzumab (Herceptin), in terms of response rate and time to progression, in postmenopausal women with metastatic or locally advanced hormone-responsive, HER2/neu positive breast cancer. Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on day 1 and oral exemestane once daily. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-60 patients will be accrued for this study.

Official Title
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Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Biological: trastuzumab
* Drug: exemestane


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed breast cancer Stage IV or locally advanced disease Staged by bone scan or CT scan of chest and/or abdomen within the past 6 weeks HER2/neu positive by fluorescent in situ hybridization (if 2+ by immunohistochemistry) or 3+ by immunohistochemistry Measurable disease defined by 1 of the following criteria: At least 1 dimension at least 1 cm by CT scan or other imaging scan At least 1 diameter at least 1 cm by plain x-ray (excluding bone lesions) Palpable lesion with both diameters at least 1 cm with caliper OR Evaluable disease defined by 1 of the following criteria: Positive bone scan Palpable masses with diameter less than 1 cm, masses with margins not clearly defined on CT scan or x-ray, or with both diameters less than 1 cm Bone scan and CA 27.29 if bone scan only evaluable disease Hormone receptor status: Estrogen receptor and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age 18 and over Sex Female Menopausal status Postmenopausal by 1 of the following criteria: 60 years of age and over 45 years of age and over with amenorrhea more than 12 months and an intact uterus Follicle-stimulating hormone levels within postmenopausal range Undergone bilateral oophorectomy Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Not specified Hepatic Bilirubin less than 1.5 times upper limit of normal Renal Creatinine less than 2 mg/dL Cardiovascular Ejection fraction greater than 50% Other Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy No prior trastuzumab (Herceptin) Chemotherapy Prior chemotherapy allowed Endocrine therapy No prior exemestane No other prior hormonal agent (except tamoxifen) Radiotherapy Not specified Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: trastuzumab|nan|
|Drug: exemestane|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer