Trial · NCT00754325
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
NCT00754325, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2016-05-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor. Trials, record NCT00754325. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00754325
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
- NCT number
- NCT00754325
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 100 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Advanced Breast Cancer
- Interventions
- Dasatinib, Fulvestrant
- First posted
- 2008-09-17
- Last updated
- 2016-05-26
- Results first posted
- 2016-05-25
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 Disease Progression (PD) or Death | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization. Participants lost to follow-up were censored at the last date of contact. Participants that had not progressed or died had PFS censored at the date of last follow-up. |
| Secondary | Median Time of Progression-free Survival (PFS) | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Progression free survival (PFS) was defined as the time in months from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. 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. |
| Secondary | Percentage of Participants With Progression Free Survival (PFS) at 6 Months | at 6 months | PFS rate was defined as the percentage of participants experiencing no disease progression or death from any cause at 6 months after randomization. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. 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. Kaplan Meier assessments were used to estimate the percentages. |
| Secondary | Percentage of Participants With Clinical Benefit for At Least 6 Months | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Clinical benefit rate (CBR) was defined as the percentage of participants that had Stable Disease (SD), complete response (CR), or partial response (PR) for greater than or equal to 6 months if there was no evidence of progression at or before assessment performed on or after Study Day 161. 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 (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD) | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Table represents the best response achieved over this time frame. 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 | Number of Participants With Best Overall Response | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Best overall response rate (ORR) = number of participants with measurable lesions by Response Evaluation Criteria in Solid Tumors (RECIST) having a best response of complete response (CR) or partial response (PR) divided by number of randomized participants. RECIST 1.1 response criteria applies. To be recorded as best response, CR or PR had to be confirmed at ≥ 4 weeks interval. An unconfirmed CR was recorded as PR. |
| Secondary | Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. Serious adverse event (SAE) defined: 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 Disease Progression (PD) or Death | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included as non-responders. Censored participants = 15 Fulvestrant and Dasatinib, 9 Fulvestrant | participants | NUMBER |
| SECONDARY | Median Time of Progression-free Survival (PFS) | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | months | MEDIAN |
| SECONDARY | Percentage of Participants With Progression Free Survival (PFS) at 6 Months | at 6 months | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Clinical Benefit for At Least 6 Months | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD) | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Evaluable population on initial treatment; all treated participants with measurable disease at baseline and at least one on-study tumor assessment. Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | participants | NUMBER |
| SECONDARY | Number of Participants With Best Overall Response | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Evaluable population on initial treatment with measurable lesion by RECIST (Response Evaluation Criteria In Solid Tumors). Participants without tumor response assessment due to rapid progression or study drug toxicity included in population as non-responders. | participants | NUMBER |
| SECONDARY | Number of Participants With Serious Adverse Events, Death, and Discontinuation Due to Adverse Events | Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years) | Safety Population on initial treatment; any participants that was randomized to any treatment group in the study and received at least one treatment therapy. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group26
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 Disease Progression (PD) or Death | Fulvestrant and Dasatinib | 35 | participants | ||
| Number of Participants With Disease Progression (PD) or Death | Fulvestrant | 40 | participants | ||
| Median Time of Progression-free Survival (PFS) | Fulvestrant and Dasatinib | 5.6 | 95% Confidence Interval 3.6 to 9.3 | months | |
| Median Time of Progression-free Survival (PFS) | Fulvestrant | 5.3 | 95% Confidence Interval 3.0 to 7.4 | months | |
| Percentage of Participants With Progression Free Survival (PFS) at 6 Months | Fulvestrant and Dasatinib | 48.1 | 95% Confidence Interval 33.0 to 61.7 | percentage of participants | |
| Percentage of Participants With Progression Free Survival (PFS) at 6 Months | Fulvestrant | 44.6 | 95% Confidence Interval 30.1 to 58.1 | percentage of participants | |
| Percentage of Participants With Clinical Benefit for At Least 6 Months | Fulvestrant and Dasatinib | 38.0 | 95% Confidence Interval 24.7 to 52.8 | percentage of participants | |
| Percentage of Participants With Clinical Benefit for At Least 6 Months | Fulvestrant | 42.9 | 95% Confidence Interval 28.8 to 57.8 | percentage of participants | |
| Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD) | Fulvestrant and Dasatinib | Complete Response, CR | 0 | participants | |
| Number of Participants With Complete Response (CR) , Partial Response (PR), Stable Disease (SD), and Disease Progression (PD) | Fulvestrant | Complete Response, CR | 0 | participants |
1 to 10 of 26Source ClinicalTrials.gov
See all 26 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Treatment | STARTED | Fulvestrant and Dasatinib | 50 | |
| Initial Treatment | STARTED | Fulvestrant | 49 | |
| Initial Treatment | COMPLETED | Fulvestrant and Dasatinib | 0 | |
| Initial Treatment | COMPLETED | Fulvestrant | 0 | |
| Initial Treatment | NOT COMPLETED | Fulvestrant and Dasatinib | 50 | |
| Initial Treatment | NOT COMPLETED | Fulvestrant | 49 | |
| Progression and Cross-over | STARTED | Fulvestrant and Dasatinib | 0 | |
| Progression and Cross-over | STARTED | Fulvestrant | 21 | |
| Progression and Cross-over | COMPLETED | Fulvestrant and Dasatinib | 0 | |
| Progression and Cross-over | COMPLETED | Fulvestrant | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events234
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 | Anemia | Blood and lymphatic system disorders | Fulvestrant and Dasatinib | 13 | 50 | |
| other | Anemia | Blood and lymphatic system disorders | Fulvestrant | 7 | 49 | |
| other | Anemia | Blood and lymphatic system disorders | Fulvestrant Crossover to Fulvestrant and Dasatinib | 5 | 21 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fulvestrant and Dasatinib | 3 | 50 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fulvestrant | 1 | 49 | |
| other | Leukopenia | Blood and lymphatic system disorders | Fulvestrant Crossover to Fulvestrant and Dasatinib | 1 | 21 | |
| other | Neutropenia | Blood and lymphatic system disorders | Fulvestrant and Dasatinib | 7 | 50 | |
| other | Neutropenia | Blood and lymphatic system disorders | Fulvestrant | 2 | 49 | |
| other | Neutropenia | Blood and lymphatic system disorders | Fulvestrant Crossover to Fulvestrant and Dasatinib | 1 | 21 | |
| other | Effusion Pericardial | Cardiac disorders | Fulvestrant and Dasatinib | 3 | 50 |
1 to 10 of 234Source ClinicalTrials.gov
See all 234 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fulvestrant and Dasatinib | ||
| Total, all-cause mortality | Fulvestrant | ||
| Total, all-cause mortality | Fulvestrant Crossover to Fulvestrant and Dasatinib | ||
| Total, other adverse events | Fulvestrant and Dasatinib | 48 | 50 |
| Total, other adverse events | Fulvestrant | 44 | 49 |
| Total, other adverse events | Fulvestrant Crossover to Fulvestrant and Dasatinib | 20 | 21 |
| Total, serious adverse events | Fulvestrant and Dasatinib | 14 | 50 |
| Total, serious adverse events | Fulvestrant | 11 | 49 |
| Total, serious adverse events | Fulvestrant Crossover to Fulvestrant and Dasatinib | 7 | 21 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Fulvestrant and Dasatinib vs Fulvestrant: Number of Participants With Best Overall Response | Trial comparisons |
| Fulvestrant and Dasatinib vs Fulvestrant: Number of Participants With Disease Progression (PD) or Death | 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.
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