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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:
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
History of Changes
  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:

U.S. FDA Resources

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:
  • 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

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

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.

  Show 49 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
US Oncology Research
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
Investigator Inquiry form  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

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 June 13, 2013