Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
US Oncology Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00696072
First received: June 10, 2008
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Dasatinib + Letrozole
Drug: Letrozole
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Determine the clinical benefit rate with letrozole or with letrozole plus dasatinib [ Time Frame: (CBR equal to CR+PR+SD ≥6 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response rate in patients who receive letrozole plus dasatinib or single-agent letrozole [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • Median PFS in patients in both Arms [ Time Frame: at 6 and 12 months ] [ Designated as safety issue: No ]
  • Overall response rate & CBR in patients who crossover to either Arm 1b or Arm 2b [ Time Frame: at 2 years ] [ Designated as safety issue: No ]
  • PFS for both treatment arms [ Time Frame: at 6- and 12-months ] [ Designated as safety issue: No ]
  • Time to treatment failure (TTF) [ Time Frame: at 6 months and 1 year ] [ Designated as safety issue: No ]
  • Changes in bone markers [ Time Frame: at 6 months and 1 year ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: at each clinic visit ] [ Designated as safety issue: Yes ]
  • Effect on bone pain [ Time Frame: at each clinic visit ] [ Designated as safety issue: No ]
  • Bone Mineral Density changes [ Time Frame: between baseline and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: October 2008
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Dasatinib + Letrozole

Tablets, Oral, once daily, up to 2 years

Dasatinib 100 mg + Letrozole 2.5 mg

Other Names:
  • Sprycel
  • BMS-354825
  • Femara
Active Comparator: A2 Drug: Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Other Name: Femara

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Has histologic or cytologic diagnosis of breast cancer; evidence of unresectable locally recurrent or metastatic disease
  • Has measurable or evaluable-only disease
  • Is female, ≥18 yrs of age, post menopausal or surgically sterile
  • HER2 negative, HR+, ER+ and/or PgR+ breast cancer
  • 0-1 prior chemotherapy regimen for metastatic disease.
  • Prior adjuvant or neoadjuvant chemotherapy completed at least 1 month prior
  • Prior tamoxifen therapy is allowed
  • No AI therapy for >1 year without recurrence

Exclusion Criteria:

  • Pregnant or breast feeding
  • Prior hormonal therapy for metastatic or locally recurrent disease
  • >1 chemotherapy regimen for metastatic disease
  • Pleural or pericardial effusion
  • Serious cardiac condition
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00696072

Locations
United States, Arizona
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
Arizona Oncology Associates D.B.A. Hematology Oncology
Tucson, Arizona, United States, 85704
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
United States, Florida
Florida Cancer Institute - New Hope
Hudson, Florida, United States, 34667
United States, Indiana
Central Indiana Cancer Centers
Carmel, Indiana, United States, 46032
United States, New York
New York Oncology Hematology, Pc
Troy, New York, United States, 12180
United States, Ohio
Dayton Oncology And Hematology
Kettering, Ohio, United States, 45409
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
Northwest Cancer Specialists, Pc
Portland, Oregon, United States, 97213
United States, Pennsylvania
Medical Oncology Associates
Kingston, Pennsylvania, United States, 18704
United States, Texas
Texas Oncology-Central Austin Cancer Center
Austin, Texas, United States, 78731
Texas Oncology
Bedord, Texas, United States, 76022
Texas Oncology
Dallas, Texas, United States, 75231
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Cancer Center At Medical City
Dallas, Texas, United States, 75230
El Paso Cancer Treatment Ctr - East
El Paso, Texas, United States, 79915
Texas Oncology
Fort Worth, Texas, United States, 76104
Texas Oncology
Garland, Texas, United States, 75042
Texas Oncology
Houston, Texas, United States, 77024
Texas Oncology-Plano East
Plano, Texas, United States, 75075
Cancer Care Centers Of South Texas
San Antonio, Texas, United States, 78217
Texas Oncology Cancer Center - Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
Texas Oncology Cancer Care And Research Center
Waco, Texas, United States, 76712
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Oncology & Hematology Associates Of Southwest Virginia, Inc.
Salem, Virginia, United States, 24153
United States, Washington
Yakima Valley Memorial Hospital/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
Bristol-Myers Squibb
US Oncology Research
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00696072     History of Changes
Other Study ID Numbers: CA180-185, USOR 06-185
Study First Received: June 10, 2008
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Dasatinib
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014