Comparison · NCT00754325-5e0b2f99
Fulvestrant and Dasatinib vs Fulvestrant: Number of Participants With Disease Progression (PD) or Death
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 Disease Progression (PD) or Death. Trial comparisons, record NCT00754325-5e0b2f99. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00754325-5e0b2f99
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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 | 0.7 | 0.562 | 0.809 | wilson | |
| Risk in group 2 | 0.816 | 0.686 | 0.9 | wilson | |
| Risk difference, group 1 minus group 2 | -0.116 | -0.277 | 0.0532 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.857 | 0.685 | 1.07 | log | |
| Odds ratio, group 1 over group 2 | 0.525 | 0.205 | 1.35 | log | |
| Number needed to treat, for one fewer participant with the outcome on Fulvestrant and Dasatinib than on Fulvestrant | 8.6 | 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 | 35 | 50 | 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. | 40 | 49 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Number of Participants With Disease Progression (PD) or Death
- Description
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.
- 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; 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
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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