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

Robert H. Lurie Cancer Center

Status and phase

Withdrawn

Phase 2

Conditions

Stage IIIA Breast Cancer

Stage IIIB Breast Cancer

Stage IIIC Breast Cancer

Stage II Breast Cancer

Treatments

Procedure: hormone therapy

Procedure: adjuvant therapy

Procedure: endocrine therapy

Procedure: conventional surgery

Procedure: aromatase inhibition

Procedure: surgery

Drug: exemestane

Procedure: neoadjuvant therapy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00080613

NU-02B4

CDR0000346457 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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