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

Primary Purpose

Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
exemestane
adjuvant therapy
aromatase inhibition
conventional surgery
endocrine therapy
hormone therapy
neoadjuvant therapy
surgery
Sponsored by
Robert H. Lurie Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stage II Breast Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2004
Last Updated
July 9, 2013
Sponsor
Robert H. Lurie Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00080613
Brief Title
Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Official Title
Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2006
Overall Recruitment Status
Withdrawn
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Robert H. Lurie Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
exemestane
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
aromatase inhibition
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Type
Procedure
Intervention Name(s)
endocrine therapy
Intervention Type
Procedure
Intervention Name(s)
hormone therapy
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
surgery

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William John Gradishar, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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