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

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ClinicalTrials.gov Identifier: NCT00080613
Recruitment Status : Withdrawn
First Posted : April 8, 2004
Last Update Posted : July 10, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment 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 2

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.


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Study Type : Interventional  (Clinical Trial)
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 the National Library of Medicine

Drug Information available for: Exemestane





Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00080613


Locations
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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
National Cancer Institute (NCI)
Investigators
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Principal Investigator: William John Gradishar, MD Robert H. Lurie Cancer Center

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ClinicalTrials.gov Identifier: NCT00080613     History of Changes
Other Study ID Numbers: NU-02B4
CDR0000346457 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: April 8, 2004    Key Record Dates
Last Update Posted: July 10, 2013
Last Verified: December 2006

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Exemestane
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists