Trial · NCT03901339
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
NCT03901339, Phase 3, Completed, Gilead Sciences; results first posted 2024-10-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer. Trials, record NCT03901339. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03901339
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
- NCT number
- NCT03901339
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 543 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Metastatic Breast Cancer
- Interventions
- Sacituzumab Govitecan-hziy, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
- First posted
- 2019-04-03
- Last updated
- 2024-10-21
- Other registries' IDs
- eudract:2018-004201-33
- Results first posted
- 2024-10-21
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment | Up to 42.8 months | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. |
| Secondary | Overall Survival (OS) | Up to 42.8 months | OS was defined as the time from the date of randomization to the date of death from any cause. OS was estimated using Kaplan-Meier estimate. Participants without documentation of death were censored on the date they were last known to be alive. |
| Secondary | Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment | Up to 42.8 months | ORR was defined as the percentage of participants who had the best overall response of either complete response (CR) or partial response (PR) that was confirmed at 4 weeks or later after initial response by BICR and LIR using RECIST 1.1. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. |
| Secondary | Duration of Response (DOR) by BICR and LIR Assessment | Up to 42.8 months | DOR was defined as the time from the date a response of CR or PR was first documented until the date of the first documentation of disease progression or date of death (whichever occurred first). DOR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. DOR was estimated using Kaplan-Meier estimate. |
| Secondary | Clinical Benefit Rate (CBR) by BICR and LIR Assessment | Up to 42.8 months | CBR was defined as the percentage of participants with the best overall response of CR, PR, or durable stable disease (duration of SD ≥ 6 months after randomization). CBR was analyzed based on both BICR and LIR assessments. CR: Disappearance of all target and non-target lesions; and normalization of tumor marker levels initially above upper limits of normal; PR: ≥30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD. SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum LD since the treatment started. PD: Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. |
| Secondary | PFS by LIR Assessment | Up to 42.8 months | PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to LIR using RECIST 1.1. Disease progression was defined as an increase of greater than 20% in the sum of the LD of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appearance of new non-target lesions. PFS was estimated using Kaplan-Meier estimate. |
| Secondary | Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30) | Up to 37.8 months | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the global health status/QoL scale.The EORTC QLQ-C30 is a 30-item questionnaire to assess QoL of cancer patients. It has 5 functional scales(physical,role,emotional,cognitive, social)1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). Participant responses to global health status,'How would you rate your overall health during the past week?' (Item 29)and the QoL 'How would you rate your overall quality of life during the past week?'(Item 30)questions were scored on 7-point scale (1=very poor; 7=excellent). All scales and single-item measures range in score from 0 to 100. Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores for GHS show a better level of functioning. |
| Secondary | TTD of Pain Score as Measured by EORTC QLQ-C30 | Up to 37.8 months | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the pain score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties). All of the scales and single-item measures range in score from 0 to 100. Participant responses to 2 questions about pain, 'Have you had pain' and 'Did pain interfere with your daily activities' were scored on 4-point scale (1=not at all;4=very much). Summed raw scores were standardized by linear transformation so that scores ranges from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). |
| Secondary | TTD of Fatigue Score as Measured by EORTC QLQ-C30 | Up to 37.8 months | TTD was defined as the time from randomization to the first date a subject achieves 10-point deterioration from baseline in the fatigue score.The EORTC QLQ-C30 is a questionnaire to assess quality of life, it is composed of 30 questions(items) resulting in 5 functional scales(physical, role, emotional, cognitive, social),1 global health status scale,3 symptom scales (fatigue, nausea and vomiting, pain),and 6 single items(dyspnea, insomnia, loss of appetite, constipation, diarrhea, financial difficulties).All of the scales and single-item measures range in score from 0 to 100.Participant responses to 3 questions about fatigue 'Did you need to rest', 'Have you felt weak' and 'Were you tired' were scored on a 4-point scale (1=not at all;4=very much).Summed raw scores were standardized by linear transformation so that scores ranged from 0 to 100. Higher scores on the symptom scales indicate a higher level of symptoms (i.e. a worse state of the participant). |
| Secondary | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | Up to 43.4 months | An AE was defined as any untoward medical occurrence in a subject administered a medicinal product that does not necessarily have a causal relationship with this treatment. TEAEs were defined as any AEs that begin or worsen on or after the start of study drug through 30 days after the last dose of the study drug. The severity was graded based on the National Cancer Institute's Common Terminology Criteria for Adverse Events Version 5.0. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 Blinded Independent Central Review (BICR) Assessment | Up to 42.8 months | The ITT Population included all participants who were randomized, regardless of whether they received study treatment or not. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Up to 42.8 months | Participants in the ITT Population were analyzed. | months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment | Up to 42.8 months | Participants in the ITT Population with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Duration of Response (DOR) by BICR and LIR Assessment | Up to 42.8 months | Participants in the ITT Population with confirmed objective response were analyzed. | months | MEDIAN |
| SECONDARY | Clinical Benefit Rate (CBR) by BICR and LIR Assessment | Up to 42.8 months | Participants in the ITT Population with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | PFS by LIR Assessment | Up to 42.8 months | Participants in the ITT Population were analyzed. | months | MEDIAN |
| SECONDARY | Time to Deterioration (TTD) of Global Health Status/Quality of Life (QoL) Scale as Measured by European Organization for Research and Treatment of Cancer Quality of Life for Cancer Patients, Core Questionnaire Version 3.0 (EORTC QLQ-C30) | Up to 37.8 months | The HRQOL-Evaluable Population included all participants who had an evaluable assessment at baseline and at least 1 evaluable assessment at postbaseline visits. Participants with a baseline global health status/QOL score ≥ 10 were analyzed. | months | MEDIAN |
| SECONDARY | TTD of Pain Score as Measured by EORTC QLQ-C30 | Up to 37.8 months | Participants in the HRQOL-Evaluable Population with baseline pain score ≤ 90 were analyzed. | months | MEDIAN |
| SECONDARY | TTD of Fatigue Score as Measured by EORTC QLQ-C30 | Up to 37.8 months | Participants in the HRQOL-Evaluable Population with baseline fatigue score ≤ 90 were analyzed. | months | MEDIAN |
| SECONDARY | Percentage of Participants Who Experienced Treatment Emergent Adverse Events (TEAEs) | Up to 43.4 months | The Safety Population included all participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group82
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 Blinded Independent Central Review (BICR) Assessment | Sacituzumab Govitecan | 5.5 | 95% Confidence Interval 4.2 to 6.9 | months | |
| Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) Assessment | Treatment of Physician's Choice (TPC) | 4.0 | 95% Confidence Interval 3.0 to 4.4 | months | |
| Overall Survival (OS) | Sacituzumab Govitecan | 14.5 | 95% Confidence Interval 13.0 to 16.0 | months | |
| Overall Survival (OS) | Treatment of Physician's Choice (TPC) | 11.2 | 95% Confidence Interval 10.2 to 12.6 | months | |
| Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment | Sacituzumab Govitecan | ORR by BICR Assessment | 21.3 | 95% Confidence Interval 16.6 to 26.7 | percentage of participants |
| Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment | Treatment of Physician's Choice (TPC) | ORR by BICR Assessment | 14.0 | 95% Confidence Interval 10.1 to 18.7 | percentage of participants |
| Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment | Sacituzumab Govitecan | ORR by LIR Assessment | 16.5 | 95% Confidence Interval 12.3 to 21.5 | percentage of participants |
| Objective Response Rate (ORR) by BICR and Local Investigator Review (LIR) Assessment | Treatment of Physician's Choice (TPC) | ORR by LIR Assessment | 9.2 | 95% Confidence Interval 6.1 to 13.3 | percentage of participants |
| Duration of Response (DOR) by BICR and LIR Assessment | Sacituzumab Govitecan | DOR by BICR Assessment | 8.1 | 95% Confidence Interval 6.7 to 8.9 | months |
| Duration of Response (DOR) by BICR and LIR Assessment | Treatment of Physician's Choice (TPC) | DOR by BICR Assessment | 5.6 | 95% Confidence Interval 3.8 to 7.9 | months |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 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 | 272 | |
| Overall Study | STARTED | Treatment of Physician's Choice (TPC) | 271 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Sacituzumab Govitecan | 268 | |
| Overall Study | Received at Least 1 Dose of Study Drug | Treatment of Physician's Choice (TPC) | 249 | |
| Overall Study | COMPLETED | Sacituzumab Govitecan | 0 | |
| Overall Study | COMPLETED | Treatment of Physician's Choice (TPC) | 0 | |
| Overall Study | NOT COMPLETED | Sacituzumab Govitecan | 272 | |
| Overall Study | NOT COMPLETED | Treatment of Physician's Choice (TPC) | 271 |
Source ClinicalTrials.gov
Adverse events306
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 | 97 | 268 | |
| other | Anaemia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 68 | 249 | |
| other | Leukopenia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 37 | 268 | |
| other | Leukopenia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 25 | 249 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 32 | 268 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 29 | 249 | |
| other | Neutropenia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 184 | 268 | |
| other | Neutropenia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 134 | 249 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Sacituzumab Govitecan | 17 | 268 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Treatment of Physician's Choice (TPC) | 41 | 249 |
1 to 10 of 306Source ClinicalTrials.gov
See all 306 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sacituzumab Govitecan | 234 | 272 |
| Total, all-cause mortality | Treatment of Physician's Choice (TPC) | 238 | 271 |
| Total, other adverse events | Sacituzumab Govitecan | 264 | 268 |
| Total, other adverse events | Treatment of Physician's Choice (TPC) | 234 | 249 |
| Total, serious adverse events | Sacituzumab Govitecan | 74 | 268 |
| Total, serious adverse events | Treatment of Physician's Choice (TPC) | 48 | 249 |
Source ClinicalTrials.gov
Papers9
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/NCT03901339
GET https://conductscience.org/api/trials/v1/NCT03901339/results?page=2