Study Evaluating Bosutinib-Exemestane Combination Vs Exemestane Alone in Post Menopausal Women With Breast Cancer

NCT00793546 | Terminated Phase 2 Results

• 2 other identifiers: 3160A6-2206B1871009
• Study Type: interventional
• Target: 42
• Locations: 11 countries
• Sites: 27

Brief Summary

This is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. This is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. Subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. If no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. They will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. Subjects will be followed up for survival after treatment discontinuation.

Conditions

Advanced Breast Cancer

Keywords

Bosutinib; Exemestane; postmenopausal; breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) Based on Independent Radiologist

  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").

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

Secondary Outcomes (11)

• Percentage of Participants With Treatment-Emergent Adverse Events (AEs) And Serious Adverse Events (SAEs)

  Baseline up to 28 days after the last dose

• Progression Free Survival (PFS) Based on Investigator

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

• Percentage of Participants With Objective Response

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

• Overall Survival (OS)

  Part 2 Baseline until death or up to 24 months

• Duration of Response (DR)

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

Study Arms (2)

1

EXPERIMENTAL

combination of bosutinib and exemestane

Drug: Bosutinib; Drug: exemestane

2

ACTIVE COMPARATOR

exemestane

Drug: Exemestane

Interventions

Bosutinib DRUG

300 mg =(3x100mg) tablets once daily during the active phase of treatment until disease progression, unacceptable toxicity or withdrawal of consent occurs

1

Exemestane DRUG

25 mg tablet once daily

1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (28)

Pfizer Investigational Site

Lake Worth, Florida, 33461, United States

Location

Pfizer Investigational Site

Joliet, Illinois, 60435, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02114, United States

Location

Pfizer Investigational Site

Boston, Massachusetts, 02115, United States

Location

Pfizer Investigational Site

Detroit, Michigan, 84202, United States

Location

Pfizer Investigational Site

New Brunswick, New Jersey, 08901, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

Bethlehem, Pennsylvania, 18015, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Pfizer Investigational Site

Philadelphia, Pennsylvania, 19104, United States

Location

Pfizer Investigational Site

Seattle, Washington, 98104, United States

Location

Pfizer Investigational Site

South Brisbane, Queensland, 4101, Australia

Location

Pfizer Investigational Site

Brussels, Brussels Capital, 1000, Belgium

Location

Pfizer Investigational Site

Leuven, Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Liège, Liege, 4000, Belgium

Location

Pfizer Investigational Site

Wilrijk, 2610, Belgium

Location

Pfizer Investigational Site

Kelowna, British Columbia, V1Y 5L3, Canada

Location

Pfizer Investigational Site

Beijing, 100021, China

Location

Pfizer Investigational Site

Hong Kong, Hong Kong

Location

Pfizer Investigational Site

Budapest, 1122, Hungary

Location

Pfizer Investigational Site

Mumbai, Maharashtra, 400012, India

Location

Pfizer Investigational Site

Pune, Maharashtra, 411001, India

Location

Pfizer Investigational Site

Olsztyn, 10-513, Poland

Location

Pfizer Investigational Site

Lynnwood, Gauteng, 0081, South Africa

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Madrid, Madrid, 28040, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46010, Spain

Location

Pfizer Investigational Site

Location

Related Publications (1)

• Moy B, Neven P, Lebrun F, Bellet M, Xu B, Sarosiek T, Chow L, Goss P, Zacharchuk C, Leip E, Turnbull K, Bardy-Bouxin N, Duvillie L, Lang I. Bosutinib in combination with the aromatase inhibitor exemestane: a phase II trial in postmenopausal women with previously treated locally advanced or metastatic hormone receptor-positive/HER2-negative breast cancer. Oncologist. 2014 Apr;19(4):346-7. doi: 10.1634/theoncologist.2014-0022. Epub 2014 Mar 27.

  PMID: 24674873 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bosutinib; exemestane

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

Results are not provided because the study was terminated prior to part 2 due to unfavorable risk benefit ratio of the study treatment.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2008
• First Posted: November 19, 2008
• Study Start: February 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 5, 2012
• Results First Posted: November 5, 2012

Record last verified: 2012-10

Locations

CA (1); HK (1); IN (2); ZA (1); ES (3); PL (1); BE (4); AU (1); HU (1); US (11); CN (1)