Trial · 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
NCT00696072, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2016-05-11
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00696072. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00696072
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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
- NCT number
- NCT00696072
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Metastatic Breast Cancer
- Interventions
- Dasatinib, Letrozole
- First posted
- 2008-06-12
- Last updated
- 2016-06-13
- Results first posted
- 2016-05-11
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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 | Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | 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. |
| Secondary | Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population | 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. |
| Secondary | Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib | 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. |
| Secondary | Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population | 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. |
| Secondary | Median Time to Treatment Failure (TTF) - ITT Population | 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. |
| Secondary | Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) | Evaluable Population was defined as all treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of randomized study drug. Participants presented in the treatment arm to which they were originally randomized. | participants | NUMBER |
| SECONDARY | Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) | All treated participants who met the protocol-specified efficacy analyses requirements and who received at least 1 dose of study drug were analyzed. The participants are analyzed as per the treatment arm to which they were originally randomized. | participants | NUMBER |
| SECONDARY | Median Progression Free Survival (PFS) - Intent to Treat (ITT) Population | Day 1 to Study Completion (approximately 6 years) | ITT population includes all participants enrolled in the study. The participants were analyzed as per the treatment arm to which they were originally randomized. | months | MEDIAN |
| SECONDARY | Percentage of Participants Best Overall Response After Change From Letrozole to Letrozole Plus Dasatinib | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) | Participants who changed their treatment regimen from single-agent letrozole to letrozole + dasatinib during the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With PFS At 6 Months and At 12 Months - ITT Population | At 6 months and at 12 months | ITT population=Includes all participants registered on the study. n= number at risk | percentage of participants | NUMBER |
| SECONDARY | Median Time to Treatment Failure (TTF) - ITT Population | First dose of study drug to last dose plus 7 days, up to study completion (approximately 6 years) | ITT population: All participants enrolled in the study. | Months | MEDIAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) Leading to Discontinuation, Serious Adverse Events (SAEs), and Deaths | First dose of study drug to last dose plus 30 days, up to study completion (approximately 6 years) | All participants who received at least one dose of study drug were summarized. The participants were analyzed as per the treatment arm to which they were originally randomized. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Dasatinib Plus Letrozole | CBR (CR+PR+SD) | 40 | participants | |
| 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 | Letrozole | CBR (CR+PR+SD) | 40 | participants | |
| 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 | Dasatinib Plus Letrozole | CBR, DFI <= 2 Years | 20 | participants | |
| 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 | Letrozole | CBR, DFI <= 2 Years | 20 | participants | |
| 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 | Dasatinib Plus Letrozole | CBR, DFI > 2 Years | 20 | participants | |
| 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 | Letrozole | CBR, DFI > 2 Years | 20 | participants | |
| Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | Dasatinib Plus Letrozole | CR | 1 | participants | |
| Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | Letrozole | CR | 0 | participants | |
| Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | Dasatinib Plus Letrozole | PR | 12 | participants | |
| Number of Participants With Complete Response, Partial Response, Stable Disease, and Disease Progression | Letrozole | PR | 15 | participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dasatinib Plus Letrozole | 57 | |
| Overall Study | STARTED | Letrozole | 63 | |
| Overall Study | COMPLETED | Dasatinib Plus Letrozole | 0 | |
| Overall Study | COMPLETED | Letrozole | 0 | |
| Overall Study | NOT COMPLETED | Dasatinib Plus Letrozole | 57 | |
| Overall Study | NOT COMPLETED | Letrozole | 63 |
Source ClinicalTrials.gov
Adverse events242
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal Pain | Gastrointestinal disorders | Dasatinib Plus Letrozole | 5 | 57 | |
| other | Abdominal Pain | Gastrointestinal disorders | Letrozole | 4 | 63 | |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Dasatinib Plus Letrozole | 0 | 57 | |
| other | Abdominal Pain Lower | Gastrointestinal disorders | Letrozole | 3 | 63 | |
| other | Acne | Skin and subcutaneous tissue disorders | Dasatinib Plus Letrozole | 4 | 57 | |
| other | Acne | Skin and subcutaneous tissue disorders | Letrozole | 1 | 63 | |
| other | Allergy | Immune system disorders | Dasatinib Plus Letrozole | 3 | 57 | |
| other | Allergy | Immune system disorders | Letrozole | 1 | 63 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Dasatinib Plus Letrozole | 1 | 57 | |
| other | Alopecia | Skin and subcutaneous tissue disorders | Letrozole | 4 | 63 |
1 to 10 of 242Source ClinicalTrials.gov
See all 242 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib Plus Letrozole | ||
| Total, all-cause mortality | Letrozole | ||
| Total, other adverse events | Dasatinib Plus Letrozole | 56 | 57 |
| Total, other adverse events | Letrozole | 57 | 63 |
| Total, serious adverse events | Dasatinib Plus Letrozole | 14 | 57 |
| Total, serious adverse events | Letrozole | 2 | 63 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Dasatinib Plus Letrozole vs Letrozole: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00696072
GET https://conductscience.org/api/trials/v1/NCT00696072/results?page=2