A Phase 2 interventional study of Dasatinib and Letrozole in Metastatic Breast Cancer, sponsored by Bristol-Myers Squibb. Completed at 27 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-13.
Sponsored by Bristol-Myers Squibb · Phase 2, Interventional, and Treatment
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
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 120 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
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Inclusion Criteria:
Exclusion Criteria:
Drug: Dasatinib · Drug: Letrozole
Drug: Letrozole
Tablets, Oral, 100 mg once daily, up to 2 years
Also known as: Sprycel, BMS-354825
Tablets, Oral, 2.5 mg, once daily, up to 2 years
Also known as: Femara
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
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.
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression
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.
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population
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.
Time frame: Day 1 to Study Completion (approximately 6 years)
Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib
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.
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population
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.
Time frame: At 6 months and at 12 months
Median Time to Treatment Failure (TTF) - ITT Population
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.
Time frame: First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years)
Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths
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.
Time frame: First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years)
Study started October 2008 and completed June 2014; 23 participants chose to remain on active treatment after the study completed.
| Milestone | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| Started | 57 | 63 |
| Completed | 0 | 0 |
| Not completed | 57 | 63 |
| Withdrew: Continuing active treatment | 10 | 13 |
| Withdrew: Adverse event | 10 | 6 |
| Withdrew: Patient request | 3 | 7 |
| Withdrew: Investigator request | 1 | 4 |
| Withdrew: Sponsor request | 0 | 1 |
| Withdrew: Disease progression | 32 | 30 |
| Withdrew: Non-specified | 1 | 2 |
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.
| participants | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| CBR (CR+PR+SD) | 40 | 40 |
| CBR, DFI <= 2 Years | 20 | 20 |
| CBR, DFI > 2 Years | 20 | 20 |
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.
| participants | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| CR | 1 | 0 |
| PR | 12 | 15 |
| SD | 32 | 30 |
| SD >=6 months | 27 | 25 |
| PD | 7 | 16 |
| Not Evaluable | 4 | 0 |
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.
| months | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population | 20.1 (10.7 to 28.4) | 9.9 (7.4 to 19.8) |
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 | Crossed Over From Letrozole to Letrozole + Dasatinib |
|---|---|
| Best Response of SD | 34.3 (19.1 to 52.2) |
| Best Response of SD ≥6 months | 22.9 (10.4 to 40.1) |
| Best Response of CBR | 22.9 (10.4 to 40.1) |
| Best Response of PD | 20.0 (8.4 to 36.9) |
| Best Response Not Available | 2.9 (0.1 to 14.9) |
| Best Response Not Evaluable | 2.9 (0.1 to 14.9) |
| Best Response Pending | 40.0 (23.9 to 57.9) |
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.
| percentage of participants | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| 6 Month (n=39, 39) | 77.2 (63.3 to 86.4) | 66.2 (53.0 to 76.5) |
| 12 Month (n=29, 20) | 64.6 (49.8 to 76.1) | 42.9 (29.77 to 55.5) |
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.
| Months | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| Median Time to Treatment Failure (TTF) - ITT Population | 10.2 (5.8 to 18.5) | 9.2 (5.5 to 11.1) |
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.
| participants | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| Deaths | 11 | 16 |
| SAEs | 14 | 2 |
| AEs Leading to Discontinuation | 10 | 6 |
Collected over First dose of study drug to last dose plus 30 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dasatinib Plus Letrozole | — | 14/57 (24.6%) | 56/57 (98.2%) |
| Letrozole | — | 2/63 (3.2%) | 57/63 (90.5%) |
| Event | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| Effusion PleuralRespiratory, thoracic and mediastinal disorders | 3/57 | 0/63 |
| CVABlood and lymphatic system disorders | 2/57 | 0/63 |
| NauseaGastrointestinal disorders | 2/57 | 0/63 |
| CholecystitisHepatobiliary disorders | 2/57 | 0/63 |
| Chest painMusculoskeletal and connective tissue disorders | 2/57 | 0/63 |
| Disease ProgressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/57 | 0/63 |
| Hypersensitivity ReactionImmune system disorders | 1/57 | 0/63 |
| Coronary InsufficiencyCardiac disorders | 1/57 | 0/63 |
| CholelithiasisGastrointestinal disorders | 1/57 | 0/63 |
| DehydrationGastrointestinal disorders | 1/57 | 1/63 |
| Event | Dasatinib Plus Letrozole | Letrozole |
|---|---|---|
| FatigueGeneral disorders | 29/57 | 27/63 |
| PainGeneral disorders | 19/57 | 29/63 |
| NauseaGastrointestinal disorders | 26/57 | 21/63 |
| DiarrheaGastrointestinal disorders | 18/57 | 12/63 |
| Hot FlashesEndocrine disorders | 18/57 | 18/63 |
| AnemiaBlood and lymphatic system disorders | 17/57 | 8/63 |
| RashSkin and subcutaneous tissue disorders | 16/57 | 9/63 |
| VomitingGastrointestinal disorders | 15/57 | 10/63 |
| HeadacheNervous system disorders | 15/57 | 11/63 |
| ConstipationGastrointestinal disorders | 14/57 | 9/63 |
Intent to treat (ITT) population
| Age, Customized(participants) | Dasatinib Plus Letrozole | Letrozole | Total |
|---|---|---|---|
| Less than 65 years | 33 | 34 | 67 |
| Greater than or equal to 65 years | 24 | 29 | 53 |
| Sex: Female, Male(Participants) | Dasatinib Plus Letrozole | Letrozole | Total |
|---|---|---|---|
| Female | 57 | 63 | 120 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Dasatinib Plus Letrozole | Letrozole | Total |
|---|---|---|---|
| United States | 57 | 63 | 120 |
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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