Comparison · NCT00754325-1ea4d7ac
Fulvestrant and Dasatinib vs Fulvestrant: Number of Participants With Best Overall Response
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Fulvestrant and Dasatinib vs Fulvestrant: Number of Participants With Best Overall Response. Trial comparisons, record NCT00754325-1ea4d7ac. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00754325-1ea4d7ac
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0323 | 0.00572 | 0.162 | wilson | |
| Risk in group 2 | 0.0541 | 0.015 | 0.177 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0218 | -0.148 | 0.114 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.597 | 0.0568 | 6.27 | log | |
| Odds ratio, group 1 over group 2 | 0.583 | 0.0504 | 6.76 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fulvestrant and Dasatinib than on Fulvestrant | 45.9 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Fulvestrant and Dasatinib | Arm 1: Participants in this group received a drug regimen that consisted of both fulvestrant and dasatinib.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years.~Dasatinib: Tablets, Oral, 100 mg, once daily (QD), up to 2 years | 1 | 31 | OG000 |
| Group 2 | Fulvestrant | Arm 2: Participants in this group received a drug regimen that consisted of fulvestrant only.~Fulvestrant: Intramuscular injection (IM), loading dose (500 mg) on Day 1 followed by 500 mg on Day 15 of Cycle 1 (28-day cycle). In subsequent cycles, 500 mg IM administered on Day 1, up to 2 years. | 2 | 37 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Best Overall Response
- Description
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.
- Time frame
- Date of randomization to date of initial disease progression, or date of death (whichever occurs first), up to January 2014 (approximately 5 years)
- Population
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.
Source ClinicalTrials.gov
Trial
- 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
- Phases
- PHASE2
- Conditions
- Advanced Breast Cancer
- Interventions
- Dasatinib, Fulvestrant
- Lead sponsor
- Bristol-Myers Squibb
- Results first posted
- 2016-05-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00754325?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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