This trial is active, not recruiting.

Condition breast cancer
Treatments exemestane, laboratory biomarker analysis, quality-of-life assessment, immunohistochemistry staining method
Phase phase 2
Sponsor City of Hope Medical Center
Collaborator National Cancer Institute (NCI)
Start date December 2008
End date July 2017
Trial size 36 participants
Trial identifier NCT00810797, 08063, CDR0000629864, CHNMC-08063, NCI-2010-00761, P30CA033572


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Patients receive oral exemestane once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Given orally
laboratory biomarker analysis
One year after completion of study treatment
quality-of-life assessment
One year after completion of study treatment
immunohistochemistry staining method immunohistochemistry
Correlative studies

Primary Outcomes

Progression-free survival measured by RECIST
time frame: 4 months after the start of treatment

Secondary Outcomes

Objective response
time frame: Assessed up to 1 year
Toxicity as assessed by NCI CTCAE version 3.0
time frame: Assessed up to 1 year
Compliance with medication adherence
time frame: Assessed up to 1 year
Quality of life as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
time frame: On day 1 of each treatment course
Bone health
time frame: 21 days after the start of the last course of treatment
Serum hormone levels
time frame: 21 days after the start of the last course of treatment

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Intermittent Exemestane Therapy for Metastatic Breast Cancer
Principal investigator George Somlo, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by City of Hope Medical Center.