Trial · NCT05552001
Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
NCT05552001, Phase 3, Active not recruiting, UNICANCER
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer. Trials, record NCT05552001. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05552001
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
- NCT number
- NCT05552001
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 96 participants, estimated
- Lead sponsor
- UNICANCER
- Conditions
- Triple Negative Breast Cancer, Metastatic Breast Cancer
- Interventions
- Sacituzumab govitecan
- First posted
- 2022-09-23
- Last updated
- 2026-07-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (ORR) | From inclusion to disease progression, up to 6 months | ORR is defined as the number of patient with at least a confirmed complete response (CR) or partial response (PR), based on the best objective response values while on treatment |
| Secondary | Progression-free survival (PFS) | From inclusion to disease progression or death, up to 2 years | PFS iis the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. |
| Secondary | Duration of response (DOR) | From inclusion to disease progression or death, up to 2 years | DOR is defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of disease progression or death due to any cause |
| Secondary | Clinical benefice risk (CBR) | From inclusion to disease progression or death, up to 2 years | CBR is defined as the presence of at least a PR or CR, or a stable disease (SD) while on treatment |
| Secondary | Overall Survival (OS) | From inclusion to disease progression or death, up to 2 years | The overall survival is the length of time from randomization that patients enrolled in the study are still alive. |
| Secondary | The incidence of adverse events (Safety) | Throughout study completion, up to 36 months | Safety and tolerability of sacituzumab govitecan will be evaluated using the National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5). NCI-CTCAE is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05552001
GET https://conductscience.org/api/trials/v1/NCT05552001/registered