Trial · NCT02574455
Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
NCT02574455, Phase 3, Completed, Gilead Sciences; results first posted 2021-04-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC). Trials, record NCT02574455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02574455
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Sacituzumab Govitecan in Participants With Refractory/Relapsed Metastatic Triple-Negative Breast Cancer (TNBC)
- NCT number
- NCT02574455
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 529 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Breast Cancer
- Interventions
- Sacituzumab govitecan, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
- First posted
- 2015-10-12
- Last updated
- 2022-06-15
- Other registries' IDs
- eudract:2017-003019-21
- Results first posted
- 2021-04-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population | From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | PFS was defined as the time from randomization until objective tumor progression by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (greater than or equal to \[≥\] 20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. |
| Secondary | Progression-Free Survival (PFS) by IRC Assessment in the ITT Population | From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | PFS was defined as the time from randomization until objective tumor progression by RECIST v1.1 or death, whichever came first. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. |
| Secondary | Overall Survival (OS) in BM-ve Population | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) | Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. |
| Secondary | Overall Survival (OS) in ITT Population | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) | Overall survival (OS) was defined as the time from the randomization to death from any cause. OS was estimated using Kaplan-Meier estimate. |
| Secondary | Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population | From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | ORR was defined as the percentage of participants who had the overall best response as either a confirmed complete response (CR) or partial response (PR) relative to the size of population under evaluation. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; and no new lesions. |
| Secondary | Time to Objective Response by the Investigator Assessment in BM-ve Population | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. |
| Secondary | Time to Objective Response by the IRC Assessment in BM-ve Population | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Time to response was defined as the time from randomization to the first recorded objective response (ie, CR or PR). CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. |
| Secondary | Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population | From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | DOR was defined as the number of days between the first date showing a documented response of CR or PR and the date of progression or death. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; and no new lesions. PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD; and no new lesions. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. |
| Secondary | Time to Progression (TTP) by Investigator Assessment in BM-ve Population | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. |
| Secondary | Time to Progression (TTP) by IRC Assessment in BM-ve Population | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Time to Progression (TTP) was defined as the time from the date of randomization to the date of the first evidence of disease progression as assessed using RECIST 1.1 criteria. The date of progression was date of the last observation or radiological assessment of target lesions that either showed a predefined increase (≥20%) in the sum of the target lesions or the appearance of new non-target lesions. Participants without progression were censored. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population | From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | The BM-ve Population included all randomized participants who were randomized to the strata of no baseline brain metastasis at the time of randomization. | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS) by IRC Assessment in the ITT Population | From randomization until objective tumor progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | The ITT Population included all randomized participants. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in BM-ve Population | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) | Participants in the BM-ve Population were analyzed. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in ITT Population | From the randomization to death from any cause (maximum follow-up duration: 30.8 months) | Participants in the ITT Population were analyzed. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population | From randomization to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Participants in the BM-ve Population with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Time to Objective Response by the Investigator Assessment in BM-ve Population | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Participants in the BM-ve Population with objective response were analyzed. | months | MEAN |
| SECONDARY | Time to Objective Response by the IRC Assessment in BM-ve Population | From randomization to the first recorded objective response (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Participants in the BM-ve Population with objective response were analyzed. | months | MEAN |
| SECONDARY | Duration of Response (DOR) by IRC and Investigator Assessment in BM-ve Population | From the first date of documented response of CR or PR to the date of progression or death (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Participants in the BM-ve Population with objective response were analyzed. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) by Investigator Assessment in BM-ve Population | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Participants in the BM-ve Population were analyzed. | months | MEDIAN |
| SECONDARY | Time to Progression (TTP) by IRC Assessment in BM-ve Population | From randomization until disease progression (assessed every 6 weeks for 9 months and then every 9 weeks thereafter until the occurrence of progression of disease; maximum exposure: 29.6 months) | Participants in the BM-ve Population were analyzed. | months | MEDIAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group138
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population | Sacituzumab Govitecan | 5.6 | 95% Confidence Interval 4.3 to 6.3 | months | |
| Progression-Free Survival (PFS) by Independent Review Committee (IRC) Assessment in Brain Metastasis Negative (BM-ve) Population | Treatment of Physician's Choice (TPC) | 1.7 | 95% Confidence Interval 1.5 to 2.6 | months | |
| Progression-Free Survival (PFS) by IRC Assessment in the ITT Population | Sacituzumab Govitecan | 4.8 | 95% Confidence Interval 4.1 to 5.8 | months | |
| Progression-Free Survival (PFS) by IRC Assessment in the ITT Population | Treatment of Physician's Choice (TPC) | 1.7 | 95% Confidence Interval 1.5 to 2.5 | months | |
| Overall Survival (OS) in BM-ve Population | Sacituzumab Govitecan | 12.1 | 95% Confidence Interval 10.7 to 14.0 | months | |
| Overall Survival (OS) in BM-ve Population | Treatment of Physician's Choice (TPC) | 6.7 | 95% Confidence Interval 5.8 to 7.7 | months | |
| Overall Survival (OS) in ITT Population | Sacituzumab Govitecan | 11.8 | 95% Confidence Interval 10.5 to 13.8 | months | |
| Overall Survival (OS) in ITT Population | Treatment of Physician's Choice (TPC) | 6.9 | 95% Confidence Interval 5.9 to 7.7 | months | |
| Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population | Sacituzumab Govitecan | ORR by IRC Assessment | 34.9 | 95% Confidence Interval 28.8 to 41.4 | percentage of participants |
| Objective Response Rate (ORR) by IRC and Investigator Assessment in BM-ve Population | Treatment of Physician's Choice (TPC) | ORR by IRC Assessment | 4.7 | 95% Confidence Interval 2.4 to 8.3 | percentage of participants |
1 to 10 of 138Source ClinicalTrials.gov
See all 138 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sacituzumab Govitecan | 267 | |
| Overall Study | STARTED | Treatment of Physician's Choice (TPC) | 262 | |
| Overall Study | Enrolled and Treated | Sacituzumab Govitecan | 258 | |
| Overall Study | Enrolled and Treated | Treatment of Physician's Choice (TPC) | 224 | |
| Overall Study | COMPLETED | Sacituzumab Govitecan | 0 | |
| Overall Study | COMPLETED | Treatment of Physician's Choice (TPC) | 0 | |
| Overall Study | NOT COMPLETED | Sacituzumab Govitecan | 267 | |
| Overall Study | NOT COMPLETED | Treatment of Physician's Choice (TPC) | 262 |
Source ClinicalTrials.gov
Adverse events290
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 | Anaemia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 102 | 258 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 61 | 224 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 108 | 258 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 56 | 224 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 9 | 258 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 14 | 224 | |
| other | Abdominal pain | Gastrointestinal disorders | Sacituzumab Govitecan | 54 | 258 | |
| other | Abdominal pain | Gastrointestinal disorders | Treatment of Physician's Choice (TPC) | 16 | 224 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Sacituzumab Govitecan | 23 | 258 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Treatment of Physician's Choice (TPC) | 8 | 224 |
1 to 10 of 290Source ClinicalTrials.gov
See all 290 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sacituzumab Govitecan | 201 | 267 |
| Total, all-cause mortality | Treatment of Physician's Choice (TPC) | 222 | 262 |
| Total, other adverse events | Sacituzumab Govitecan | 256 | 258 |
| Total, other adverse events | Treatment of Physician's Choice (TPC) | 213 | 224 |
| Total, serious adverse events | Sacituzumab Govitecan | 69 | 258 |
| Total, serious adverse events | Treatment of Physician's Choice (TPC) | 64 | 224 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Sacituzumab Govitecan vs Treatment of Physician's Choice (TPC): deaths from any cause | Trial comparisons |
| Sacituzumab Govitecan vs Treatment of Physician's Choice (TPC): 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/NCT02574455
GET https://conductscience.org/api/trials/v1/NCT02574455/results?page=2