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

May 10, 2016 updated by: Bristol-Myers Squibb
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: A1
Drug: Dasatinib
Tablets, Oral, 100 mg once daily, up to 2 years
Other Names:
  • BMS-354825
  • Sprycel
Drug: Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Other Names:
  • Femara
Active Comparator: A2
Drug: Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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.
First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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.
First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population
Time Frame: Day 1 to Study Completion (approximately 6 years)
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.
Day 1 to Study Completion (approximately 6 years)
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)
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.
First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population
Time Frame: At 6 months and at 12 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. ITT population: from time of first enrollment to first PD for all ITT participants.
At 6 months and at 12 months
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)
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.
First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
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)
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.
First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
US Oncology Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 12, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 13, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA180-185
  • USOR 06-185

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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