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Home > "T" Clinical Trials Conditions > Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer  Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
For Condition: stage 3C breast cancer,stage 4 breast cancer,stage 3A breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): Robert H. Lurie Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: The monoclonal antibodytrastuzumab 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
VirginiaKaklamani, Principal Investigator, Robert H. Lurie Cancer Center
Silver Cross Hospital *Recruiting*
Joliet, Illinois, 60432
United States
Recruiting Lawrence Schilder 815-740-1400
Marshfield Clinic *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting William Hocking 715-387-5426
Hematology-Oncology Associates of Illinois *Recruiting*
Chicago, Illinois, 60611-2998
United States
Recruiting Claudia Tellez 312-664-5400
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611-3013
United States
Recruiting Virginia Kaklamani 312-695-6180
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting Ruth O'Regan 404-778-5177
Additional Information:
Study ID Numbers: CDR0000285670; NU-01B4,PHARMACIA-NU-01B4
Study Start Date:
Record last reviewed: March 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00057993
Other Stage 4 Breast Cancer Studies:
1. Comparison of Biological Therapies Following Combination Chemotherapy and Bone Marrow or Peripheral Stem Cell Transplantation in Women With Stage II or Stage III Breast Cancer
2. Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
3. Lymph Node Radiation Therapy in Patients with Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed
4. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
5. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
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Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
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