Trial · NCT07366840
RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure
NCT07366840, Phase 2, Phase 3, Not yet recruiting, Fudan University
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure. Trials, record NCT07366840. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07366840
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RC48 Combined With Chemotherapy in HER2-Positive Advanced Breast Cancer Patients With Prior TOP1i-ADC Failure
- NCT number
- NCT07366840
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 268 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer
- Interventions
- Disitamab Vedotin, Gemcitabine, Capecitabine, Trastuzumab, Inetetamab
- First posted
- 2026-01-26
- Last updated
- 2026-01-26
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median progression free survival (by investigator) | The observation period for this endpoint is up to 36 months, and will be terminated early upon disease progression or death. | Progression-Free Survival (PFS), analyzed using the Kaplan-Meier method, is defined as the time from randomization to the first occurrence of disease progression or death, whichever comes first. For subjects without evidence of disease progression or death at the time of analysis, data will be censored at the date of their last tumor assessment. |
| Secondary | Objective Response Rate (by investigator) | Baseline at screening and the time of the identification of disease progression, assessed up to 36 months. | Objective response rate (ORR), defined as best overall response of either complete or partial response based on RECIST 1.1 criteria, will be assessed among participants who have measurable disease at screening and start protocol therapy. |
| Secondary | Median overall survival (by investigator) | The observation period for this endpoint will be terminated upon death or if disease progression occurs after 1 year of follow-up. | Overall Survival (OS), analyzed using the Kaplan-Meier method, is defined as the time from randomization to death from any cause. For participants who remain alive at the time of analysis, data will be censored at the date of last contact or informed consent withdrawal. |
| Secondary | Duration of response (by investigator) | The observation period for this endpoint is up to 36 months, and will be terminated early upon disease progression or death. | Duration of Overall Response (DOR) is defined as the time from the first documentation of meeting the criteria for Complete Response (CR) or Partial Response (PR) to the first date of objectively confirmed disease recurrence, progression, or death from any cause. For disease progression, the reference shall be the smallest tumor measurements recorded since the initiation of treatment. |
| Secondary | Disease control rate (by investigator) | The observation period for this endpoint is up to 36 months, and will be terminated early upon disease progression or death. | Disease control rate (DCR) is defined as the percentage of participants with CR, PR, or stable disease (SD) by investigator per RECIST v1.1. |
| Secondary | Adverse events | The observation period for this endpoint is up to 36 months. | The number of participants who experienced an adverse event (AE) based on the Common Toxicity Criteria for Adverse events Version 5.0 (CTCAEv5) as reported on case report forms, whether or not considered related to the investigational medicines. |
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT07366840
GET https://conductscience.org/api/trials/v1/NCT07366840/registered