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Completed

NCT Number: NCT00696072

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

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Northern Arizona Hematology & Oncology Associates, Sedona, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dasatinib

Drug

Tablets, Oral, 100 mg once daily, up to 2 years

Other names: Sprycel, BMS-354825

letrozole

Drug

Tablets, Oral, 2.5 mg, once daily, up to 2 years

Other names: Femara

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • US Oncology Research

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2008
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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