Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Study Overview
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Brief Summary
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The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

Official Title
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Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Exemestane
* Drug: Fulvestrant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Proven breast cancer Metastatic or locally advanced breast cancer Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry) Postmenopausal status No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed ECOG (Eastern Cooperative Oncology Group) performance status 0-2 Adequate organ function Exclusion Criteria: No prior Exemestane or Fulvestrant Uncontrolled intercurrent illness including but not limited to: ongoing or active infection symptomatic congestive heart failure unstable angina pectoris cardiac arrhythmia myocardial infarction within the last 3 months psychiatric illness/social situations that would limit compliance with study Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease. Presence of bleeding diathesis or coagulopathy, patients requiring coumadin

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-arm study<br>Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection | Drug: Exemestane<br>* 25 mg orally per day<br>* Other names: Aromasin;Drug: Fulvestrant<br>* 250 mg IM starting on Day 8 and then every 28 days.<br>* Other names: Faslodex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant. | TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). 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 | Every 2 cycles up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease) | Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria. Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 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; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR | Every 2 cycles, up to 1 year | 
| Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant | 5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points. | Day 7 and Day 120 | 
| Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels |  | Prestudy, Day 7 and Day 120 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postmenopausal, Women