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Neoadjuvant and Adjuvant Exemestane in Treating Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer
This study has been withdrawn prior to enrollment.

First Received on April 7, 2004.   Last Updated on January 11, 2007   History of Changes
Sponsor: Robert H. Lurie Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00080613
  Purpose

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.


Condition Intervention Phase
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IIIC Breast Cancer
Drug: exemestane
Procedure: adjuvant therapy
Procedure: aromatase inhibition
Procedure: conventional surgery
Procedure: endocrine therapy
Procedure: hormone therapy
Procedure: neoadjuvant therapy
Procedure: surgery
Phase II

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant and Adjuvant Exemestane in Postmenopausal Women With Locally Advanced Hormone Receptor-Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00080613

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Robert H. Lurie Cancer Center
Investigators
Principal Investigator: William John Gradishar, MD Robert H. Lurie Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00080613     History of Changes
Other Study ID Numbers: CDR0000346457, NU-02B4
Study First Received: April 7, 2004
Last Updated: January 11, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Hormones
Exemestane
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 12, 2012