Exemestane in Treating Postmenopausal Women With Stage IV Breast Cancer

NCT ID: NCT00810797

Last Updated: 2020-10-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-02
• Study Completion Date: 2019-06-26

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Progression-free survival at 4 months, as measured by Response Evaluation Criteria in Solid Tumors (RECIST).

SECONDARY OBJECTIVES:

I. Objective response rate (complete response [CR] and partial response [PR]).

II. Clinical benefit (CR, PR, and stable disease >= 6 months).

III. Assessment of toxicity.

IV. Assessment of compliance with medication adherence.

V. Assessment of quality of life.

VI. Assessment of bone health.

TERTIARY OBJECTIVES:

I. Serial measurements of serum estradiol, estrone, and estrone sulfate.

II. To investigate treatment resistance (e.g., expression of amphiregulin, epidermal growth factor receptor [EGFR]), using molecular and immunohistochemical analyses of blood and tumor samples of pre- and post- (when available) treatment tissues. Microarray analyses to quantitate the expression of specific estrogen-responsive genes (e.g. thyroid transcription factor 1 [TTF1] and PDZK1) will also be performed.

OUTLINE: Patients receive exemestane orally (PO) once daily (QD) on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 1 year.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (exemestane)

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

Group Type: EXPERIMENTAL

exemestane

Intervention Type: DRUG

Given orally

laboratory biomarker analysis

Intervention Type: OTHER

One year after completion of study treatment

quality-of-life assessment

Intervention Type: PROCEDURE

One year after completion of study treatment

immunohistochemistry staining method

Intervention Type: OTHER

Correlative studies

Interventions

exemestane

Given orally

Intervention Type: DRUG

laboratory biomarker analysis

One year after completion of study treatment

Intervention Type: OTHER

quality-of-life assessment

One year after completion of study treatment

Intervention Type: PROCEDURE

immunohistochemistry staining method

Correlative studies

Intervention Type: OTHER

Other Intervention Names

immunohistochemistry

Eligibility Criteria

Inclusion Criteria

• 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
• Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) levels =< 2.5 x ULN in patients without liver metastases or =< 5 times ULN in patients with liver metastases
• Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver metastases
• Subjects must have an estimated life expectancy of greater than 6 months

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

City of Hope Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George Somlo, MD

Role: PRINCIPAL_INVESTIGATOR

City of Hope Medical Center

Locations

City of Hope Medical Center

Duarte, California, United States

South Pasadena Cancer Center

South Pasadena, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

P30CA033572

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CHNMC-08063

Identifier Type: -

Identifier Source: secondary_id

CDR0000629864

Identifier Type: REGISTRY

Identifier Source: secondary_id

NCI-2010-00761

Identifier Type: REGISTRY

Identifier Source: secondary_id

08063

Identifier Type: -

Identifier Source: org_study_id