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
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| ClinicalTrials.gov Identifier: NCT00696072 |
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Recruitment Status :
Completed
First Posted : June 12, 2008
Results First Posted : May 11, 2016
Last Update Posted : June 13, 2016
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Sponsor:
Bristol-Myers Squibb
Collaborator:
US Oncology Research
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Metastatic Breast Cancer | Drug: Dasatinib Drug: Letrozole | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | August 2008 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | June 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: A1 |
Drug: Dasatinib
Tablets, Oral, 100 mg once daily, up to 2 years
Other Names:
Drug: Letrozole Tablets, Oral, 2.5 mg, once daily, up to 2 years
Other Name: Femara |
| Active Comparator: A2 |
Drug: Letrozole
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Other Name: Femara |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00696072
Locations
Show 27 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
US Oncology Research
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT00696072 |
| Other Study ID Numbers: |
CA180-185 USOR 06-185 |
| First Posted: | June 12, 2008 Key Record Dates |
| Results First Posted: | May 11, 2016 |
| Last Update Posted: | June 13, 2016 |
| Last Verified: | May 2016 |
Additional relevant MeSH terms:
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Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Letrozole Dasatinib Antineoplastic Agents Aromatase Inhibitors |
Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Protein Kinase Inhibitors |