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

Phase 2CompletedNCT00201864

Ohio State University Comprehensive Cancer Center40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

ExemestaneDRUG

25 mg orally per day

FulvestrantDRUG

250 mg IM starting on Day 8 and then every 28 days.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ohio State University

Columbus, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: Every 2 cycles up to 2 years

Secondary Outcomes

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

Time frame: 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.

Time frame: Day 7 and Day 120

Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels

Data from ClinicalTrials.gov

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