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Completed

NCT Number: NCT00201864

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Ohio State University

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exemestane

Drug

25 mg orally per day

Other names: Aromasin

Fulvestrant

Drug

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

Other names: Faslodex

Primary outcomes

  1. Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.

    Time frame: Every 2 cycles up to 2 years

    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

Secondary outcomes

  1. Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)

    Time frame: Every 2 cycles, up to 1 year

    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

  2. Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant

    Time frame: Day 7 and Day 120

    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.

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

    Time frame: Prestudy, Day 7 and Day 120

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2012
Study completion
2014
First posted
Sep 20, 2005
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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