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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 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

June 10, 2008
May 10, 2016
August 2008
June 2014   (final data collection date for primary outcome measure)
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.
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
  • 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.
  • 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
    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: A1
    Interventions:
    • Drug: Dasatinib
    • Drug: 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.
 
Completed
120
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00696072
CA180-185, USOR 06-185
Yes
Not Provided
Not Provided
Bristol-Myers Squibb
Bristol-Myers Squibb
US Oncology Research
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
May 2016

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