A Study of Dasatinib (BMS-354825) in Patients With Advanced 'Triple-negative' Breast Cancer

NCT00371254 | Completed Phase 2 Results

• 1 other identifier: CA180-059
• Study Type: interventional
• Target: 55
• Locations: 4 countries
• Sites: 10

Brief Summary

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced triple-negative breast cancer.

Conditions

Breast Cancer; Metastasis

Keywords

Recurrent, locally-advanced, or 'triple negative' metastatic breast cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Complete Response (CR) or Partial Response (PR)

  Tumor response was defined as the number of participants whose best response was CR or PR, per the Response Evaluation Criteria in Solid Tumor (RECIST): CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.

  Baseline to end of study drug therapy (up to 65 weeks).

• Percentage of Participants With Complete Response (CR) or Partial Response (PR)

  The percentage of participants whose best response was CR or PR, per the RECIST: CR: disappearance of all target/non-target lesions; PR: \>= 30% decrease in the sum of the LDs of target lesions relative to the baseline sum LD.

  Baseline to end of study drug therapy (up to 65 weeks).

Secondary Outcomes (21)

• Number of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study

  Baseline to 16 weeks.

• Percentage of Participants With Complete Response (CR), Partial Response (PR) or Stable Disease (SD) at or After 16 Weeks on Study

  Baseline to 16 weeks

• Proportion of Participants With Progression-Free Survival (PFS) at Weeks 9, 17, and 25

  Weeks 9, 17, and 25

• Mean Number of Weeks of Complete Response (CR) or Partial Response (PR)

  Baseline to end of study drug therapy (up to 53.86 weeks)

• Mean Plasma Concentration at Week 3

  At pre-dose and 1, 3, 6 and 12 hours after each dose administration

Study Arms (2)

1

EXPERIMENTAL

Drug: Dasatinib

2

EXPERIMENTAL

Drug: Dasatinib

Interventions

Dasatinib DRUG

Tablets, Oral, 100 mg, twice daily as long as the patient benefits (avg \<6 months)

Also known as: Sprycel, BMS-354825

1

Eligibility Criteria

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

You may qualify if:

• females, 18 or older
• recurrent or progressive locally advanced, or 'triple negative' metastatic breast cancer
• paraffin-embedded tissue block must be available
• measurable disease
• prior chemotherapy with an anthracycline, a taxane, or both (neoadjuvant, adjuvant, or metastatic setting)
• , 1 or 2 chemotherapies in the metastatic setting
• adequate organ function

You may not qualify if:

• Metastatic disease confined to bone only
• Symptomatic CNS metastasis
• Concurrent medical condition which may increase the risk of toxicity
• Unable to take oral medication

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (10)

Ucsf-Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224, United States

Location

Dana-Farber Cancer Inst

Boston, Massachusetts, 02115, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

University Of Texas Md Anderson Cancer Ctr

Houston, Texas, 77030, United States

Location

Local Institution

Paris, 75231, France

Location

Local Institution

Toulouse, 31052, France

Location

Local Institution

Modena, 41100, Italy

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Lleida, 25198, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis; Recurrence

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: BMS Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 1, 2006
• First Posted: September 4, 2006
• Study Start: December 1, 2006
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 15, 2011
• Results First Posted: March 15, 2011

Record last verified: 2011-02

Locations

ES (2); US (5); FR (2); IT (1)