Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer

NCT00810797 | Completed Phase 2 Results DMC

• 5 other identifiers: 08063P30CA033572CHNMC-08063CDR0000629864NCI-2010-00761
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. PURPOSE: This phase II trial is studying how well exemestane works in treating postmenopausal women with stage IV breast cancer.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

  Until disease progression of death from any cause, up to 3 years

Secondary Outcomes (1)

• Overall Response Rate

  Until disease progression or off treatment, assessed up to 1 year

Study Arms (1)

Treatment (exemestane)

EXPERIMENTAL

Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Drug: exemestane; Other: laboratory biomarker analysis; Procedure: quality-of-life assessment; Other: immunohistochemistry staining method

Interventions

exemestane DRUG

Given orally

Treatment (exemestane)

laboratory biomarker analysis OTHER

One year after completion of study treatment

Treatment (exemestane)

quality-of-life assessment PROCEDURE

One year after completion of study treatment

Treatment (exemestane)

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Treatment (exemestane)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed metastatic carcinoma of the breast
• Hormone receptor (estrogen receptor \[ER\] and/or progesterone receptor \[PR\]) positive disease (defined as: ER and/or PR positivity as \>= 5% staining), as confirmed by immunohistochemistry (IHC) based on primary breast tissue or metastatic tissue
• Postmenopausal, as defined by any of the following:
• Natural menopause, with at least 1 year since last menses
• Chemotherapy-induced menopause with at least 1 year from last menses and serum luteinizing hormone (LH)/follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal range
• History of surgical or radiation-induced ovarian ablation
• For women =\< 56 years old and with a history of hysterectomy but at least one ovary intact, serum LH/FSH and estradiol levels must be within the postmenopausal range
• Postmenopausal women with disease recurrence while receiving either tamoxifen or a non-steroidal aromatase inhibitor (AI) as adjuvant therapy (as long as adjuvant hormonal therapy was taken for 6 months before disease progression) or with disease recurrence following the discontinuation/completion of adjuvant hormonal therapy
• Postmenopausal women with disease progression following either 0, 1 or 2 prior hormonal therapies for metastatic breast cancer, as long as the subject has had no prior exposure to exemestane (EXE)
• Measurable or non-measurable (but evaluable) disease, as defined by RECIST criteria
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Neutrophil count \>= 1.5 X 10\^9 cells/L
• Platelet count \>= 100 X 10\^9 cells/L
• Serum creatinine =\< 1.5 times upper limit of normal (ULN)
• Total serum bilirubin =\< 1.5 times ULN

You may not qualify if:

• Prior exposure to EXE, whether in the adjuvant or metastatic setting
• Prior history of any other cancer with the exception of non-melanoma skin cancer and treated in situ carcinoma of the cervix
• Active or symptomatic central nervous system (CNS) metastasis (stable or treated brain metastasis allowed but patients must be off decadron, if given for CNS disease)
• Hormone-receptor negative or unknown breast cancer
• More than two prior chemotherapy regimen for treatment of metastatic disease (any prior chemotherapy given in the adjuvant setting is permitted)
• Administration of any other anti-cancer therapy within 2 weeks of initiating study treatment; use of bisphosphonates, however, are permitted for patients with known bone metastases
• Treatment with any other concurrent investigational agent or anti-tumor drug (chemotherapy, antibody therapy or other biologic agents), will not be permitted
• Subjects who have had no prior exposure to endocrine therapy
• Any uncontrolled medical co-morbidity or psychiatric disorder which interferes with the ability to provide informed consent or comply with study procedures

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010-3000, United States

Location

South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Immunohistochemistry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• George Somlo, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 17, 2008
• First Posted: December 18, 2008
• Study Start: December 2, 2008
• Primary Completion: June 26, 2019
• Study Completion: June 26, 2019
• Last Updated: October 19, 2020
• Results First Posted: September 23, 2020

Record last verified: 2019-07

Locations

US (2)