Comparison · NCT04448886-1560c2e2
Sacituzumab Govitecan + Pembrolizumab vs Sacituzumab Govitecan: Objective Response Rate
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. Sacituzumab Govitecan + Pembrolizumab vs Sacituzumab Govitecan: Objective Response Rate. Trial comparisons, record NCT04448886-1560c2e2. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04448886-1560c2e2
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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 | 0.288 | 0.183 | 0.423 | wilson | |
| Risk in group 2 | 0.192 | 0.108 | 0.319 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0962 | -0.0685 | 0.255 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 0.744 | 3.03 | log | |
| Odds ratio, group 1 over group 2 | 1.7 | 0.683 | 4.25 | log | |
| Number needed to treat, for one more participant with the outcome on Sacituzumab Govitecan + Pembrolizumab than on Sacituzumab Govitecan | 10.4 | 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 | Sacituzumab Govitecan + Pembrolizumab | The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits. Each Cycle =21 Days~* Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle~* Pembrolizumab (iv) fixed dose administered once per cycle | 15 | 52 | OG000 |
| Group 2 | Sacituzumab Govitecan | The research study procedures include: screening for eligibility, research blood collections, at least two research biopsies, paired research stool collections, and study treatment including evaluations and follow up visits.~\- Sacituzumab Govitecan (iv) fixed dose, administered twice per cycle | 10 | 52 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Objective Response Rate
- Description
- Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Overall Response Rate (ORR) by RECIST 1.1
- Time frame
Assessed at baseline and every 3 cycles/9 weeks with a window of -7 days to + 3 days (e.g., between Cycle 3 Day 15 and Cycle 4 Day 4). Expected study duration is 38 months. The reported data is as of data cutoff of 3/9/2024.
- Population
A total of 110 patients were randomized. However, 6 out of 110 patients did not start treatment (4 did not meet eligibility, 1 withdrew consent prior to starting treatment, 1 died prior to starting treatment). Therefore a total of 104 patients that started treatment were analyzed.
Source ClinicalTrials.gov
Trial
- Title
- Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
- NCT number
- NCT04448886
- Phases
- PHASE2
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Interventions
- Pembrolizumab, Sacituzumab Govitecan
- Lead sponsor
- Ana C Garrido-Castro, MD
- Results first posted
- 2025-05-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04448886?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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