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

NCT01831076 | Completed Phase 2 Results DMC

• 1 other identifier: 01-0627.cc
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Breast cancer; estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; Postmenopausal; Exemestane; Tamoxifen

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate as Measured by Clinical Exam, Standard Imaging, and Surgical Pathology Findings

  Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Evaluated using chi-square analysis.

  Up to 6 months

Study Arms (2)

Treatment (exemestane, surgery)

ACTIVE COMPARATOR

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

Drug: Exemestane

treatment (exemestane, tamoxifen, surgery)

EXPERIMENTAL

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

Drug: Exemestane and tamoxifen

Interventions

Exemestane DRUG

Given PO

Also known as: 107868-30-4,, 6-Methyleneandrosta-1,, 4-diene-3,17-dione,, 713563,, Aromasin,, FCE 24304,, FCE-24304,, PNU 155971

Treatment (exemestane, surgery)

Exemestane and tamoxifen DRUG

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

treatment (exemestane, tamoxifen, surgery)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; 4-phenylthioandrosta-4,6-diene-3,17-dione; Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Anthony Elias
• Organization: University of Colorado

anthony.elias@ucdenver.edu

720-848-0347

Study Officials

• Anthony Elias, M.D

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2013
• First Posted: April 15, 2013
• Study Start: April 1, 2002
• Primary Completion: February 1, 2013
• Study Completion: January 6, 2022
• Last Updated: March 3, 2022
• Results First Posted: November 23, 2018

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)