Trial · NCT04448886
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
NCT04448886, Phase 2, Active not recruiting, Ana C Garrido-Castro, MD; results first posted 2025-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC. Trials, record NCT04448886. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04448886
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
- NCT number
- NCT04448886
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 110 participants, actual
- Lead sponsor
- Ana C Garrido-Castro, MD
- Conditions
- Invasive Breast Cancer, Metastatic Breast Cancer, HR-Positive Breast Cancer, HER2-negative Breast Cancer
- Interventions
- Pembrolizumab, Sacituzumab Govitecan
- First posted
- 2020-06-26
- Last updated
- 2026-01-15
- Results first posted
- 2025-05-30
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | 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 to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024. | Compare the progression-free survival (PFS) of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone. PFS is defined as the time from study randomization to disease progression, according to RECIST 1.1 or medical judgment, the latter based on established clinical parameters, such as rising tumor markers and physical exam evidence of progression, i.e. worsening chest wall disease, or death due to any cause, whichever occurred first. Patients alive without disease progression are censored at the date of last disease evaluation. |
| Secondary | Objective Response Rate | 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. | Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing Overall Response Rate (ORR) by RECIST 1.1 |
| Secondary | Overall Survival | 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. | Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing overall survival (OS), defined as the time from randomization (or registration) to death due to any cause with censoring at date last known alive, will be reported with Kaplan Meier estimates |
| Secondary | Clinical Benefit Rate | 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. | Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing clinical benefit rate (CBR). CBR defined as CR, PR or stable disease for ≥ 24 weeks according to RECIST 1.1 |
| Secondary | Time to Progression | 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. | Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing time to progression |
| Secondary | Duration of Response | 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. | Compare the efficacy of sacituzumab govitecan with pembrolizumab to that of sacituzumab govitecan alone by assessing the duration of response (the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented or death due to any cause) |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival | 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 to primary analysis of PFS is 38 months. The reported data is as of data cutoff of 3/9/2024. | 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. | Months | MEDIAN |
| SECONDARY | Objective Response Rate | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Survival | 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. | 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. | Months | MEDIAN |
| SECONDARY | Clinical Benefit Rate | 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. | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Progression | 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. | 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. | Months | MEDIAN |
| SECONDARY | Duration of Response | 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. | 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. | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression Free Survival | Sacituzumab Govitecan + Pembrolizumab | 8.36 | 90% Confidence Interval 5.30 to 11.05 | Months | |
| Progression Free Survival | Sacituzumab Govitecan | 6.45 | 90% Confidence Interval 3.95 to 8.32 | Months | |
| Objective Response Rate | Sacituzumab Govitecan + Pembrolizumab | 15 | Participants | ||
| Objective Response Rate | Sacituzumab Govitecan | 10 | Participants | ||
| Overall Survival | Sacituzumab Govitecan + Pembrolizumab | 20.0 | 95% Confidence Interval 16.9 to NA | Months | |
| Overall Survival | Sacituzumab Govitecan | 18.0 | 95% Confidence Interval 17.1 to 20.0 | Months | |
| Clinical Benefit Rate | Sacituzumab Govitecan + Pembrolizumab | 26 | Participants | ||
| Clinical Benefit Rate | Sacituzumab Govitecan | 26 | Participants | ||
| Time to Progression | Sacituzumab Govitecan + Pembrolizumab | 8.36 | 95% Confidence Interval 5.3 to 12.5 | Months | |
| Time to Progression | Sacituzumab Govitecan | 6.68 | 95% Confidence Interval 3.95 to 8.68 | Months |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sacituzumab Govitecan + Pembrolizumab | 52 | |
| Overall Study | STARTED | Sacituzumab Govitecan | 52 | |
| Overall Study | COMPLETED | Sacituzumab Govitecan + Pembrolizumab | 48 | |
| Overall Study | COMPLETED | Sacituzumab Govitecan | 51 | |
| Overall Study | NOT COMPLETED | Sacituzumab Govitecan + Pembrolizumab | 4 | |
| Overall Study | NOT COMPLETED | Sacituzumab Govitecan | 1 |
Source ClinicalTrials.gov
Adverse events192
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 | Neutrophil count decreased | Investigations | Sacituzumab Govitecan + Pembrolizumab | 8 | 52 | |
| other | Neutrophil count decreased | Investigations | Sacituzumab Govitecan | 8 | 52 | |
| other | White blood cell decreased | Investigations | Sacituzumab Govitecan + Pembrolizumab | 3 | 52 | |
| other | White blood cell decreased | Investigations | Sacituzumab Govitecan | 4 | 52 | |
| other | Anemia | Blood and lymphatic system disorders | Sacituzumab Govitecan + Pembrolizumab | 15 | 52 | |
| other | Anemia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 10 | 52 | |
| other | Diarrhea | Gastrointestinal disorders | Sacituzumab Govitecan + Pembrolizumab | 9 | 52 | |
| other | Diarrhea | Gastrointestinal disorders | Sacituzumab Govitecan | 16 | 52 | |
| other | Lymphocyte count decreased | Investigations | Sacituzumab Govitecan + Pembrolizumab | 3 | 52 | |
| other | Lymphocyte count decreased | Investigations | Sacituzumab Govitecan | 2 | 52 |
1 to 10 of 192Source ClinicalTrials.gov
See all 192 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sacituzumab Govitecan + Pembrolizumab | 18 | 54 |
| Total, all-cause mortality | Sacituzumab Govitecan | 22 | 56 |
| Total, other adverse events | Sacituzumab Govitecan + Pembrolizumab | 49 | 52 |
| Total, other adverse events | Sacituzumab Govitecan | 48 | 52 |
| Total, serious adverse events | Sacituzumab Govitecan + Pembrolizumab | 40 | 52 |
| Total, serious adverse events | Sacituzumab Govitecan | 36 | 52 |
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Sacituzumab Govitecan + Pembrolizumab vs Sacituzumab Govitecan: Objective Response Rate | Trial comparisons |
| Sacituzumab Govitecan + Pembrolizumab vs Sacituzumab Govitecan: deaths from any cause | Trial comparisons |
| Sacituzumab Govitecan + Pembrolizumab vs Sacituzumab Govitecan: Clinical Benefit Rate | Trial comparisons |
| Sacituzumab Govitecan + Pembrolizumab vs Sacituzumab Govitecan: serious adverse events | 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/NCT04448886
GET https://conductscience.org/api/trials/v1/NCT04448886/events?page=2