Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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 has been completed.
Sponsor:
Collaborator:
US Oncology Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00696072
First received: June 10, 2008
Last updated: May 10, 2016
Last verified: May 2016
  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
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:
  • Number of Participants With Clinical Benefit (CBR) and Number of Participants With CBR Having a Disease Free Interval (DFI) Greater Than 2 Years - Evaluable Population [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ] [ Designated as safety issue: No ]
    CBR=participants with complete response (CR) + participants with partial response (PR) + participants with stable disease (SD) for a length of time greater than, equal to 6 months. CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Physical examination,radiological assessment, and bone scans (if applicable) were used to assess outcome.


Secondary Outcome Measures:
  • Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ] [ Designated as safety issue: No ]
    CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. Progression (PD): At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  • Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population [ Time Frame: Day 1 to Study Completion (approximately 6 years) ] [ Designated as safety issue: No ]
    PFS was measured in months. Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Study initiated 2008 and completed 2014.

  • Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ] [ Designated as safety issue: No ]
    Participants in single-agent letrozole treatment arm who developed progressive disease, could continue letrozole, and add dasatinib to their treatment regimen. CBR=participants with CR + participants with partial response (PR) + participants with SD for a length of time ≥6 months divided by the total number of participants (%). CR= Disappearance of all target lesions. No new lesions. PR= At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) taking as reference the smallest sum LD since the treatment started. PD=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

  • Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population [ Time Frame: At 6 months and at 12 months ] [ Designated as safety issue: No ]
    Progression=At least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. ITT population: from time of first enrollment to first PD for all ITT participants.

  • Median Time to Treatment Failure (TTF) - ITT Population [ Time Frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) ] [ Designated as safety issue: No ]
    Time to TTF was measured in months. The number of participants with events (PD or off treatment due to any reason) was evaluated. The first PD was defined as the event for cross over participants in the single- agent letrozole treatment arm to add dasatinib to their regimen.

  • Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths [ Time Frame: First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years) ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.


Enrollment: 120
Study Start Date: August 2008
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A1 Drug: Dasatinib
Tablets, Oral, 100 mg once daily, up to 2 years
Other Names:
  • Sprycel
  • BMS-354825
Drug: Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Other Name: 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   (Adult, Senior)
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 Cancer Center At Medical City
Dallas, Texas, United States, 75230
Texas Oncology
Dallas, Texas, United States, 75231
Texas Oncology Sammons Cancer Center
Dallas, Texas, United States, 75246
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:
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
Results First Received: March 9, 2016
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Letrozole
Dasatinib
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists

ClinicalTrials.gov processed this record on December 08, 2016