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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00201864
• Other study ID #: OSU-0494
• Secondary ID: NCI-2011-03154
• Status: Completed
• Phase: Phase 2
• Start date: September 2005
• Est. completion date: February 2014

Study information

• Verified date: June 2018
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Exemestane
25 mg orally per day
• Fulvestrant
250 mg IM starting on Day 8 and then every 28 days.

Locations

Country	Name	City	State
United States	Ohio State University	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

Mrózek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, Shapiro CL. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer. 2012 Apr;12(2):151-6. doi: 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels		Prestudy, Day 7 and Day 120

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