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 currently recruiting participants.
Verified February 2012 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Collaborator:
US Oncology Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00696072
First received: June 10, 2008
Last updated: June 18, 2012
Last verified: February 2012
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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: | June 2012 (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:
|
| 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696072
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Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Hide Study LocationsLocations
| United States, Arizona | |
| Local Institution | Not yet recruiting |
| Phoenix, Arizona, United States, 85012 | |
| Contact: Site 039 | |
| Northern Arizona Hematology & Oncology Associates | Recruiting |
| Sedona, Arizona, United States, 86336 | |
| Contact: Deborah L. Lindquist, Site 021 | |
| Arizona Oncology Associates D.B.A. Hematology Oncology | Recruiting |
| Tucson, Arizona, United States, 85704 | |
| Contact: Donald J. Brooks, Site 017 | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers | Recruiting |
| Denver, Colorado, United States, 80220 | |
| Contact: Dev Paul, Site 042 | |
| United States, Florida | |
| Florida Cancer Institute - New Hope | Recruiting |
| Hudson, Florida, United States, 34667 | |
| Contact: Gail L. Wright, Site 024 | |
| Local Institution | Not yet recruiting |
| Ocala, Florida, United States, 34474 | |
| Contact: Site 008 | |
| United States, Illinois | |
| Local Institution | Not yet recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Site 037 | |
| United States, Indiana | |
| Central Indiana Cancer Centers | Recruiting |
| Carmel, Indiana, United States, 46032 | |
| Contact: Jennifer K. Morgan, Site 010 | |
| United States, Missouri | |
| Local Institution | Not yet recruiting |
| Columbia, Missouri, United States, 65201 | |
| Contact: Site 014 | |
| United States, New Jersey | |
| Local Institution | Not yet recruiting |
| Morristown, New Jersey, United States, NJ | |
| Contact: Site 036 | |
| United States, New York | |
| Local Institution | Not yet recruiting |
| New York, New York, United States, 10016 | |
| Contact: Site 002 | |
| New York Oncology Hematology, Pc | Recruiting |
| Troy, New York, United States, 12180 | |
| Contact: Regina Resta, Site 043 | |
| United States, Ohio | |
| Dayton Oncology And Hematology | Recruiting |
| Kettering, Ohio, United States, 45409 | |
| Contact: Robert Raju, Site 030 | |
| Local Institution | Not yet recruiting |
| Kettering, Ohio, United States, 45429 | |
| Contact: Site 048 | |
| United States, Oregon | |
| Willamette Valley Cancer Center | Recruiting |
| Eugene, Oregon, United States, 97401 | |
| Contact: Glenn S. Buchanan, Site 033 | |
| Northwest Cancer Specialists, Pc | Recruiting |
| Portland, Oregon, United States, 97213 | |
| Contact: John W. Smith,Ii, Site 044 503-297-7403 | |
| United States, Pennsylvania | |
| Medical Oncology Associates | Recruiting |
| Kingston, Pennsylvania, United States, 18704 | |
| Contact: Bruce H. Saidman, Site 045 | |
| United States, Texas | |
| Local Institution | Not yet recruiting |
| Abilene, Texas, United States, 79606 | |
| Contact: Site 035 | |
| Local Institution | Not yet recruiting |
| Amarillo, Texas, United States, 79106 | |
| Contact: Site 032 | |
| Texas Oncology-Central Austin Cancer Center | Recruiting |
| Austin, Texas, United States, 78731 | |
| Contact: Beth Hellerstedt, Site 038 | |
| Local Institution | Not yet recruiting |
| Beaumont, Texas, United States, 77702 | |
| Contact: Site 003 | |
| Texas Oncology | Recruiting |
| Bedord, Texas, United States, 76022 | |
| Contact: Thomas C. Anderson, Site 029 | |
| Texas Cancer Center At Medical City | Recruiting |
| Dallas, Texas, United States, 75230 | |
| Contact: Michael A. Savin, Site 012 972-566-7791 | |
| Texas Oncology Sammons Cancer Center | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Joanne L. Blum, Site 020 | |
| Texas Oncology | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: Kristi J. Mcintyre, Site 027 | |
| Usor | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Contact: Devchand Paul, Site 001 | |
| Local Institution | Not yet recruiting |
| Dallas, Texas, United States, 75237 | |
| Contact: Site 006 | |
| El Paso Cancer Treatment Ctr - East | Recruiting |
| El Paso, Texas, United States, 79915 | |
| Contact: Ragene R. Rivera, Site 034 | |
| Texas Oncology | Recruiting |
| Fort Worth, Texas, United States, 76104 | |
| Contact: Robert Ruxer, Jr., Site 016 | |
| Texas Oncology | Recruiting |
| Garland, Texas, United States, 75942 | |
| Contact: Manish Gupta, Site 028 | |
| Texas Oncology | Recruiting |
| Houston, Texas, United States, 77024 | |
| Contact: Frankie Ann Holmes, Site 026 | |
| Local Institution | Not yet recruiting |
| Lewisville, Texas, United States, 75067 | |
| Contact: Site 009 | |
| Local Institution | Not yet recruiting |
| Mesquite, Texas, United States, 75150 | |
| Contact: Site 041 | |
| Local Institution | Not yet recruiting |
| Odessa, Texas, United States, 79761 | |
| Contact: Site 018 | |
| Local Institution | Not yet recruiting |
| Paris, Texas, United States, 75460 | |
| Contact: Site 015 | |
| Texas Oncology-Plano East | Recruiting |
| Plano, Texas, United States, 75075 | |
| Contact: Christopher Stokoe, Site 049 | |
| Cancer Care Centers Of South Texas | Recruiting |
| San Antonio, Texas, United States, 78217 | |
| Contact: Sharon T. Wilks, Site 019 | |
| Local Institution | Not yet recruiting |
| Sherman, Texas, United States, 75090 | |
| Contact: Site 011 | |
| Local Institution | Not yet recruiting |
| Sugar Land, Texas, United States, 77479 | |
| Contact: Site 004 | |
| Tyler Cancer Center | Recruiting |
| Tyler, Texas, United States, 75702 | |
| Contact: Donald Richards, Site 047 | |
| Texas Oncology Cancer Care And Research Center | Recruiting |
| Waco, Texas, United States, 76712 | |
| Contact: Carlos Encarnacion, Site 025 | |
| Local Institution | Not yet recruiting |
| Webster, Texas, United States, 77598 | |
| Contact: Site 013 | |
| Local Institution | Not yet recruiting |
| Wichita Falls, Texas, United States, 76310 | |
| Contact: Site 031 | |
| Local Institution | Not yet recruiting |
| Wichita Falls, Texas, United States, 76310 | |
| Contact: Site 040 | |
| United States, Virginia | |
| Virginia Oncology Associates | Recruiting |
| Norfolk, Virginia, United States, 23502 | |
| Contact: Michael Danso, Site 046 | |
| Oncology & Hematology Associates Of Southwest Virginia, Inc. | Recruiting |
| Salem, Virginia, United States, 24153 | |
| Contact: Paul D Richards, Site 022 | |
| United States, Washington | |
| Local Institution | Not yet recruiting |
| Edmonds, Washington, United States, 98026 | |
| Contact: Site 007 | |
| Cancer Care Northwest | Recruiting |
| Spokane, Washington, United States, 99202 | |
| Contact: Robert Gersh, Site 005 | |
| Yakima Valley Memorial Hospital/North Star Lodge | Recruiting |
| Yakima, Washington, United States, 98902 | |
| Contact: Vicky E. Jones, Site 023 | |
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: | June 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Dasatinib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Protein Kinase Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013