NCT00371345

Brief Summary

This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2006

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
7 countries

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

November 5, 2010

Completed
Last Updated

April 26, 2011

Status Verified

April 1, 2011

Enrollment Period

2.2 years

First QC Date

September 1, 2006

Results QC Date

October 6, 2010

Last Update Submit

April 21, 2011

Conditions

Breast CancerMetastasis

Keywords

Recurrent, locally-advanced, or metastatic breast cancer

Outcome Measures

Primary Outcomes (3)

  • Number of Participants With Objective Response

    Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Objective tumor response was defined as a PR or CR.

    From day of first treatment through Week 25 or at time of discontinuation from study treatment.

  • Percentage of Participants With Objective Response

    Tumor response was assessed according RECIST criteria: PR=at least 30% reduction in the sum of the LD of all target lesions in reference to the baseline sum LD, CR=Disappearance of all non-target lesions. Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.

    From day of first treatment through Week 25 or at time of discontinuation from study treatment

  • Best Overall Response

    Response assessed using Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target and non-target lesions; Partial Response (PR)=≥30% decrease in sum of longest diameter (LD) of target lesions; SD=small changes not meeting above criteria; Progressive Disease (PD)=appearance of new lesion(s), ≥ 20% increase in the sum of the LD of target lesions, or progression of existing non-target lesions; Clinical Progression (cPD)=deterioration related to disease requiring treatment without radiographic PD.

    From day of first treatment through Week 25 or at time of discontinuation from study treatment

Secondary Outcomes (16)

  • Number of Response-evaluable Participants With Disease Control (DCR)

    From day of first treatment through Week 25 or at time of discontinuation from study treatment.

  • Percentage of Response-evaluable Participants With Disease Control (DCR)

    From day of first treatment through Week 25 or at time of discontinuation from study treatment.

  • Number of Participants Who Progressed

    From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)

  • Median Progression Free Survival (PFS)

    From Baseline (Week 0) to time of PD or discontinuation of last participant from study treatment (Week 45)

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

    At Weeks 9, 17, and 25

  • +11 more secondary outcomes

Study Arms (1)

Dasatinib

EXPERIMENTAL

Participants with either a Human epidermal growth factor (Her2/neu)-amplified tumor type or ER and/or PgR positive tumor types received oral dasatinib twice daily (BID).

Drug: DasatinibDrug: Dasatinib 100 mg

Interventions

DasatinibDRUG

Tablets, Oral, 70 mg, twice daily, as long as the participant benefits (average \<6 months)

Also known as: Sprycel, BMS-354825
Dasatinib
Dasatinib 100 mgDRUG

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

Also known as: Sprycel, BMS-354825
Dasatinib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • females, 18 or older
  • recurrent, locally advanced, or metastatic breast cancer with expression of ER/PR receptor and/or overexpression of Her2/neu
  • paraffin-embedded tissue block must be available
  • measurable disease
  • prior chemotherapy with an anthracycline and/or a taxane (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 central nervous system (CNS) metastasis
  • Concurrent medical condition which may increase the risk of toxicity
  • Unable to take oral medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Ucsf-Comprehensive Cancer Center

San Francisco, California, 94143, United States

Location

Mayo Clinic Florida

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 North Carolina At Chapel Hill

Chapel Hill, North Carolina, 275997305, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

University Of Texas Md Anderson Cancer Ctr

Houston, Texas, 77030, United States

Location

Local Institution

Buenos Aires, Buenos Aires, 1019, Argentina

Location

Local Institution

Buenos Aires, Buenos Aires, 1185, Argentina

Location

Local Institution

Haedo, Buenos Aires, 1684, Argentina

Location

Local Institution

Brussels, 1000, Belgium

Location

Local Institution

Brussels, 1200, Belgium

Location

Local Institution

Dijon, 21079, France

Location

Local Institution

Paris, 75231, France

Location

Local Institution

Saint-Herblain, 44805, France

Location

Local Institution

Toulouse, 31052, France

Location

Local Institution

Modena, 41100, Italy

Location

Local Institution

Arequipa, Arequipa, Peru

Location

Local Institution

Lima, Lima Province, 34, Peru

Location

Local Institution

Lima, Lima Province, LIMA 11, Peru

Location

Local Institution

Barcelona, 08035, Spain

Location

Local Institution

Lleida, 25198, Spain

Location

Local Institution

Madrid, 28041, Spain

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm MetastasisRecurrence

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

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

March 1, 2009

Study Completion

May 1, 2009

Last Updated

April 26, 2011

Results First Posted

November 5, 2010

Record last verified: 2011-04

Locations

US(7)IT(1)BE(2)AR(3)PE(3)FR(4)ES(3)