Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

NCT00080613 | Withdrawn Phase 2

• 2 other identifiers: NU-02B4CDR0000346457
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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. 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.

Conditions

Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer

Interventions

exemestane DRUG

adjuvant therapy PROCEDURE

aromatase inhibition PROCEDURE

conventional surgery PROCEDURE

endocrine therapy PROCEDURE

hormone therapy PROCEDURE

neoadjuvant therapy PROCEDURE

surgery PROCEDURE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Robert H. Lurie Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Chemotherapy, Adjuvant; Aromatase Inhibitors; Neoadjuvant Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs

Study Officials

• William John Gradishar, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 7, 2004
• First Posted: April 8, 2004
• Last Updated: July 10, 2013

Record last verified: 2006-12

Locations

US (1)