Trial · NCT07367178
Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
NCT07367178, Phase 2, Not yet recruiting, MedSIR
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer. Trials, record NCT07367178. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07367178
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+/HER2- Breast Cancer
- NCT number
- NCT07367178
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 30 participants, estimated
- Lead sponsor
- MedSIR
- Conditions
- Breast Cancer, Advanced HR+/HER2- Breast Cancer, Advanced Triple-Negative Breast Cancer
- Interventions
- Sacituzumab Govitecan (SG), Atropine, G-CSF (Granulocyte colony-stimulating factor)
- First posted
- 2026-01-26
- Last updated
- 2026-01-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To assess the incidence and severity of diarrhea during the first two treatment cycles | Baseline up to end of 2nd cycle (day 42) | Incidence of grade ≥2 diarrhea during the first two treatment cycles as assessed by the Investigator, with severity determined by the NCI-CTCAE v.6.0. |
| Secondary | To assess the incidence and severity of constipation during the first two treatment cycles | Baseline up to end of 2nd cycle (day 42) | Incidence of all grades constipation during the first two treatment cycles, as assessed by the Investigator, with severity determined by the NCI-CTCAE v.6.0. |
| Secondary | To determine the overall safety profile during the first two treatment cycles and the extended follow-up. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Overall safety profile according to the NCI-CTCAE v.6.0 during the first two treatment cycles and the extended follow-up |
| Secondary | To evaluate the incidence and severity of diarrhea during the first two treatment cycles versus extended follow-up. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Incidence of all grades diarrhea during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.6.0. |
| Secondary | To evaluate the incidence and severity of constipation during the first two treatment cycles versus extended follow-up. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Incidence of all grades constipation during the first two treatment cycles and during the extended follow-up, as assessed by the Investigator, with severity determined by NCI-CTCAE v.6.0. |
| Secondary | To assess the dose reduction rate. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Dose reduction rate, defined as the proportion of participants with dose reduction due to toxicity relative to the number of participants in the analysis set. |
| Secondary | To evaluate the dose interruption rate. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Dose interruption rate, defined as the proportion of participants with dose interruption due to toxicity relative to the number of participants in the analysis set. |
| Secondary | To analyze the discontinuation rate. | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | Discontinuation rate, defined as the proportion of participants who discontinued Study treatment to any cause relative to the number of participants in the analysis set. |
| Secondary | To assess real-world progression-free survival (rwPFS). | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | rwPFS, defined as the time between start of treatment to date of disease progression or death documented in participant medical charts, whichever date came first. |
| Secondary | To evaluate the time to treatment failure (TTF). | Until EoS (9 months after last participant is included in the Study unless premature termination of the Study) | TTF, defined as the time from the start of treatment to its discontinuation for any reason, including disease progression, treatment-related toxicity, participant withdrawal, or death. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
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/NCT07367178
GET https://conductscience.org/api/trials/v1/NCT07367178/registered