Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

NCT ID: NCT01831076

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2022-01-06

Brief Summary

This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

Detailed Description

This study will develop preliminary data regarding the efficacy and safety of exemestane in the preoperative treatment of postmenopausal women with ER+ or PR+ tumors. This trial is also designed to develop a predictive model to correlate expression of the known isoforms of ER and progesterone receptor (PR) and the aromatase enzyme with response to estrogenic deprivation using exemestane.

Conditions

Breast Cancer; Stage II Breast Cancer; Stage III Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (exemestane, surgery)

Patients receive exemestane orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Group Type: ACTIVE_COMPARATOR

Exemestane

Intervention Type: DRUG

Given PO

treatment (exemestane, tamoxifen, surgery)

Patients receive exemestane plus tamoxifen orally daily for 4 months in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Group Type: EXPERIMENTAL

Exemestane and tamoxifen

Intervention Type: DRUG

exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery

Interventions

Exemestane

Given PO

Intervention Type: DRUG

Exemestane and tamoxifen

exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery

Intervention Type: DRUG

Other Intervention Names

107868-30-4,; 6-Methyleneandrosta-1,; 4-diene-3,17-dione,; 713563,; Aromasin,; FCE 24304,; FCE-24304,; PNU 155971

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed breast cancer
• ER positive (+)
• Primary tumor 2-4 regional lymph nodes 0-2 (T2-4N0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated
• Clinical stage II/III
• Postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year
• Newly diagnosed
• Patients with prior non-breast malignancies are eligible if they have been disease free for >= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization
• Serum creatinine =< 1.5 x institutional upper limit of normal (ULN)
• Hemoglobin within normal limits for institution
• Absolute granulocyte count >= 1500
• Platelet count >= 100,000
• Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =< 2.5 x ULN
• Total bilirubin < 2 x ULN for institution
• Alkaline phosphatase < 2 x the ULN

Exclusion Criteria

• Completely resected
• Prior hormone or chemotherapy
• Unable to take oral medication
• Patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy

• Minimum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anthony Elias, M.D

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

University of Colorado Cancer Center

Aurora, Colorado, United States

Countries

United States

Other Identifiers

01-0627.cc

Identifier Type: -

Identifier Source: org_study_id