Status:
WITHDRAWN
Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Lead Sponsor:
Robert H. Lurie Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Stage II Breast Cancer
Stage IIIA Breast Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
RATIONALE: Estrogen and progesterone can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen and progesterone. ...
Detailed Description
OBJECTIVES: Primary * Determine the clinical response rate in postmenopausal women with locally advanced hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant exemestane. Se...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed breast cancer
- Locally advanced disease (stage II or III)
- Not amenable to breast-conserving therapy at the time of diagnosis
- Measurable disease meeting 1 of the following criteria:
- Bidimensionally measurable palpable lesion at least 1 cm by caliper
- Unidimensionally measurable lesion at least 1 cm by a positive mammogram, ultrasound, or MRI
- No evidence of disease outside the breast or chest wall except ipsilateral axillary lymph nodes
- Hormone receptor status:
- Estrogen and/or progesterone receptor positive
- PATIENT CHARACTERISTICS:
- Age
- Postmenopausal
- Sex
- Female
- Menopausal status
- Postmenopausal, defined as any of the following:
- Over 60 years of age
- Over 45 years of age with an intact uterus and amenorrhea for more than 12 months
- Prior hysterectomy with follicle-stimulating hormone levels within the postmenopausal range
- Prior ovarian ablation (i.e., bilateral surgical)
- Performance status
- ECOG 0-3
- Life expectancy
- Not specified
- Hematopoietic
- Not specified
- Hepatic
- Bilirubin less than 1.5 times upper limit of normal (ULN)
- Renal
- Creatinine less than 2 mg/dL
- Other
- No other prior or concurrent cancer except nonmetastatic nonmelanoma skin cancer, carcinoma in situ of the cervix, or cancer cured by surgery within the past 5 years
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- No prior biologic therapy for breast cancer
- Chemotherapy
- No prior chemotherapy for breast cancer
- Endocrine therapy
- No prior hormonal therapy for breast cancer
- Radiotherapy
- No prior radiotherapy for breast cancer
- Surgery
- Not specified
Exclusion
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00080613
Last Update
July 10 2013
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013