Trial · NCT07163481
A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors
NCT07163481, Phase 1, Not yet recruiting, Hunan Cancer Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors. Trials, record NCT07163481. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07163481
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors
- NCT number
- NCT07163481
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 12 participants, estimated
- Lead sponsor
- Hunan Cancer Hospital
- Conditions
- Stage IV (Metastatic) Breast Cancer
- Interventions
- Sacituzumab Govitecan + Fulvestrant, Sacituzumab Govitecan + Anastrozole / Exemestane
- First posted
- 2025-09-09
- Last updated
- 2025-09-16
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | through study completion, an average of 1 year | assessed by the incidence, nature, and severity of adverse events (AEs; NCI CTCAE v5.0) |
| Secondary | ORR | up to 16 weeks | Objective Response Rate: Proportion of patients with a predefined tumor size reduction (Complete Response + Partial Response |
| Secondary | DoR | From date of treatment initiation until the date of first documented progression, assessed up to 24 months | Duration of Response: Time from first response (CR/PR) to disease progression or death |
| Secondary | DCR | up to 24 weeks | Disease Control Rate: Proportion of patients achieving CR, PR, or Stable Disease (SD) |
| Secondary | PFS | From date of treatment initiation until the date of first documented progression or death from any cause, assessed up to 24 months | Progression-Free Survival: Time from treatment initiation to disease progression or death |
| Secondary | OS | From date of treatment initiation until the date of death from any cause, assessed up to 60 months | Overall Survival: Time from treatment initiation to death from any cause |
| Secondary | PROs | through study completion, an average of 1 year | according to nine items subset derived from PRO-CTCAE® Item Library Version 1.0: decreased appetite, nausea, vomiting, constipation, diarrhea, pain in the abdomen, shortness of breath, hair loss, and fatigue |
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/NCT07163481
GET https://conductscience.org/api/trials/v1/NCT07163481/registered