Trial · NCT07299409
First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.
NCT07299409, Phase 2, Recruiting, Nathalie Levasseur
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients. Trials, record NCT07299409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07299409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.
- NCT number
- NCT07299409
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 24 participants, estimated
- Lead sponsor
- Nathalie Levasseur
- Conditions
- Advanced Triple Negative Breast Cancer, Breast Cancer Metastatic, Breast Cancer
- Interventions
- Sacituzumab Govitecan (SG)
- First posted
- 2025-12-23
- Last updated
- 2026-10-06
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) of SG in advanced TNBC | Up to an average of 6 months | To evaluate the overall response rate (ORR) of Sacituzumab govitecan (SG) in advanced triple-negative breast cancer (TNBC) patients without prior treatment in the advance setting, stratified by molecular subtypes using whole-genome and transcriptome analysis (WGTA). |
| Primary | ORR of SG between HRD vs non-HRD in advanced TNBC | Up to an average of 6 months | 2\. To compare the ORR of SG between homologous recombination-deficient (HRD) vs non-HRD advanced TNBC patients without prior treatment in the advance setting, utilizing WGTA. |
| Secondary | Evaluate clinical benefit rate (CBR) of SG in advanced TNBC | Up to an average of 6 months | To evaluate the clinical benefit rate (CBR) of SG in advanced TNBC, stratified by molecular subtypes identified through WGTA. |
| Secondary | Assess progression-free survival (PFS) and overall-survival (OS) in advanced TNBC treated with SG | Up to an average of 12 months | To assess progression-free survival (PFS) and overall survival (OS) in advanced TNBC patients receiving SG, stratified by molecular subtypes using WGTA. |
| Secondary | Number of advanced TNBC participants receiving SG in first-line setting with treatment-related adverse events as assessed by CTCAE v5.0 | Up to an average of 3 months | To assess the safety and toxicity profile in advanced TNBC participants receiving SG in the first-line setting per the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 for grade 2-4 toxicities. |
| Secondary | Changes in health-related quality of life when treated with SG | At follow-up, within 30 days following the last dose of study drug | To assess changes in health-related quality of life using EORTC QLQ-CL30 version 3.0 questionnaire in advanced TNBC patients undergoing treatment with SG. |
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.
Papers4
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 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/NCT07299409
GET https://conductscience.org/api/trials/v1/NCT07299409/registered