Breast Cancer Clinical Trial
Official title:
Phase II Study Of Herceptin And Exemestane For Treatment Of Postmenopausal Women With Metastatic Hormone-Responsive, HER2/NEU Positive Breast Cancer
Verified date | June 2012 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2004 |
Est. primary completion date | August 2004 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Northwestern University | National Cancer Institute (NCI) |
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