Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
N/A
N/A
Both
Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Trial Information
Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
OBJECTIVES:
Primary
- Determine the clinical response rate in postmenopausal women with locally advanced
hormone receptor-positive breast cancer treated with neoadjuvant and adjuvant
exemestane.
Secondary
- Determine the response rate by mammography, ultrasound, MRI, and positron emission
tomography scan in patients treated with this drug.
- Determine the time to progression in patients treated with this drug.
- Compare the expression of hormone receptors and epidermal growth factor receptors
(including HER2/neu) in patients prior to and after treatment with this drug and
correlate these results with clinical response rates.
OUTLINE: Patients receive oral exemestane once daily for 16 weeks in the absence of disease
progression or unacceptable toxicity. After 16 weeks, patients undergo surgery and then
continue exemestane once daily for a total of 5 years (including the 16 weeks before
surgery).
Patients are followed every 3 months for 2 years after surgery and then every 6 months
thereafter.
PROJECTED ACCRUAL: A total of 16-46 patients will be accrued for this study within 2 years.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
William John Gradishar, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000346457
NCT ID:
NCT00080613
Start Date:
Completion Date:
Related Keywords:
- Stage II Breast Cancer
- Stage IIIA Breast Cancer
- Stage IIIB Breast Cancer
- Stage IIIC Breast Cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
