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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000346457 | Registry Identifier | PDQ (Physician Data Query) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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. Giving hormone therapy before surgery may shrink the tumor so it can be removed with breast-conserving surgery. Giving hormone therapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of neoadjuvant and adjuvant exemestane in treating postmenopausal women who have locally advancedestrogen and/or progesterone receptor-positive breast cancer.
OBJECTIVES:
Primary
Secondary
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exemestane | Drug | |||
| adjuvant therapy | Procedure | |||
| aromatase inhibition | Procedure | |||
| conventional surgery | Procedure | |||
| endocrine therapy | Procedure | |||
| hormone therapy | Procedure | |||
| neoadjuvant therapy | Procedure | |||
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| William John Gradishar, MD | Robert H. Lurie Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago | Illinois | 60611-3013 | United States |
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| surgery |
| Procedure |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
| D017024 | Chemotherapy, Adjuvant |
| D047072 | Aromatase Inhibitors |
| D020360 | Neoadjuvant Therapy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
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