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Intermittent Exemestane Therapy for Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Intermittent Exemestane Therapy for Metastatic Breast Cancer



- To determine the progression-free survival at 4 months, as measured by RECIST criteria,
in postmenopausal women with stage IV breast cancer treated with exemestane.


- To determine the objective response rate (complete response [CR] and partial response
[PR]) in these patients.

- To determine the clinical benefit of this drug, in terms of CR, PR, and stable disease
for ≥ 6 months, in these patients.

- To assess the toxicity of this drug in these patients.

- To assess patient compliance with medication adherence.

- To assess quality of life of these patients.

- To assess bone health of these patients.


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

- To investigate potential biomarkers of treatment response (e.g. Ki67, mitogen-activated
protein kinase [MAPK], phosphorylated Akt [p-Akt]) and treatment resistance 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 oral exemestane once daily on days 1-14. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.

Patients complete EORTC QLQ-C30 questionnaires on day 1 of each treatment course.

Blood samples are collected on days 1 and 15 of each treatment course for quantitation of
serum estrogen levels (estradiol, estrone, and estrone sulfate).

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

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

- Alkaline phosphatase =< 2.5 times the ULN for patients without bone or liver

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival at 4 months

Outcome Time Frame:

4 months after the start of treatment

Safety Issue:


Principal Investigator

Thehang Luu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



City of Hope Medical Center Duarte, California  91010