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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

June 10, 2008
June 18, 2012
October 2008
June 2012   (final data collection date for primary outcome measure)
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 ]
Determine the clinical benefit rate with letrozole or with letrozole plus dasatinib [ Time Frame: (CBR equal to CR+PR+SD ≥6 months) ]
Complete list of historical versions of study NCT00696072 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall response rate in patients who receive letrozole plus dasatinib or single-agent letrozole [ Time Frame: at 2 years ]
  • Median PFS in patients in both Arms [ Time Frame: at 6 and 12 months ]
  • Overall response rate & CBR in patients who crossover to either Arm 1b or Arm 2b [ Time Frame: at 2 years ]
  • PFS for both treatment arms [ Time Frame: at 6- and 12-months ]
  • Time to treatment failure (TTF) [ Time Frame: at 6 months and 1 year ]
  • Changes in bone markers [ Time Frame: at 6 months and 1 year ]
  • Toxicity [ Time Frame: at each clinic visit ]
  • Effect on bone pain [ Time Frame: at each clinic visit ]
  • Bone Mineral Density changes [ Time Frame: between baseline and 6 months ]
Not Provided
Not Provided
 
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
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

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
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Dasatinib + Letrozole

    Tablets, Oral, once daily, up to 2 years

    Dasatinib 100 mg + Letrozole 2.5 mg

    Other Names:
    • Sprycel
    • BMS-354825
    • Femara
  • Drug: Letrozole
    Tablets, Oral, 2.5 mg, once daily, up to 2 years
    Other Name: Femara
  • Active Comparator: A1
    Intervention: Drug: Dasatinib + Letrozole
  • Active Comparator: A2
    Intervention: Drug: Letrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
February 2015
June 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
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.
United States
 
NCT00696072
CA180-185, USOR 06-185
Yes
Bristol-Myers Squibb
Bristol-Myers Squibb
US Oncology Research
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP