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A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Exemestane Versus Exemestane Alone As Second Line Therapy In Postmenopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Advanced Breast Cancer

Thank you

Trial Information

A Phase 2, Randomized, Open-Label Study Of Bosutinib Administered In Combination With Exemestane Versus Exemestane Alone As Second Line Therapy In Postmenopausal Women With Locally Advanced Or Metastatic ER+/PgR+/ErbB2- Breast Cancer


This study was terminated on 19 Apr 2010 due to unfavorable risk benefit ratio which did not
support continuation in part 2 of the study. Even if the safety profile of the combination
of Bosutinib and Exemestane was acceptable 25% of subjects had treatment related liver
events including 14% of severe liver events.


Inclusion Criteria:



- Woman aged 18 years or older.

- Confirmed pathologic diagnosis of breast cancer.

- Locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to
curative treatment with surgery or radiotherapy.

- Surgically sterile or postmenopausal woman.

- Documented ER+ and/or PgR+ and erbB2- tumor.

- Progression of locally advanced or metastatic disease during treatment with a
nonsteroidal AI or tamoxifen, or progression during treatment with (or within 6
months of discontinuation of) an adjuvant nonsteroidal AI.

Exclusion Criteria:

- Prior exemestane, prior bosutinib, or any other prior anti-Src therapy.

- More than 1 prior endocrine treatment for locally advanced or MBC.

- More than 1 prior cytotoxic chemotherapy regimen in metastatic setting.

- Bone or skin as the only site of disease.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival (PFS) Based on Independent Radiologist

Outcome Description:

Time in weeks from randomization to first documentation of objective tumor progression or death due to any cause. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 7. Tumor progression was determined from oncologic assessment data (where data meet the criteria for progressive disease [PD]), or from adverse event (AE) data (where the outcome was "Death").

Outcome Time Frame:

Part 2 Baseline, every 8 weeks up to 2 to 6 weeks after last dose

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

3160A6-2206

NCT ID:

NCT00793546

Start Date:

February 2009

Completion Date:

June 2010

Related Keywords:

  • Advanced Breast Cancer
  • Bosutinib
  • Exemestane
  • postmenopausal
  • breast cancer
  • Breast Neoplasms

Name

Location
Pfizer Investigational Site Detroit, Michigan  48201
Pfizer Investigational Site Springfield, Illinois  62701-1014
Pfizer Investigational Site Bronx, New York  10461
Pfizer Investigational Site Federal Way, Washington  98003
Pfizer Investigational Site Clearwater, Florida  33761
Pfizer Investigational Site North Adams, Massachusetts  01247
Pfizer Investigational Site Kingston, Pennsylvania  18704-5535
Pfizer Investigational Site Livingston, New Jersey  07039