Trial · NCT06636981
All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial
NCT06636981, Phase 2, Recruiting, Fudan University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial. Trials, record NCT06636981. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06636981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- All Trans Retinoic Acid Combined with Toripalimab+Chemotherapy for Locally Advanced Inoperable or Metastatic Triple Negative Breast Cancer：a Multi-center, Multi-cohort Phase II Trial
- NCT number
- NCT06636981
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 129 participants, estimated
- Lead sponsor
- Fudan University
- Conditions
- Triple Negative Breast Cancer (TNBC)
- Interventions
- Cohort2: ATRA+Toripalimab+TPC, Cohort1: ATRA+Toripalimab+chemo
- First posted
- 2024-10-15
- Last updated
- 2024-12-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | up to 2 years | During the combined therapy, tumor assessment (enhanced CT) is conducted every 3 cycles (6 weeks), and the efficacy is evaluated using the RECIST 1.1 criteria. ORR will be summarized as the proportion of subjects achieving objective tumor responses (complete response or partial response). ORR and its 95% confidence interval will be calculated. |
| Secondary | Overall Survival (OS) | up to 2 years | Overall survival (OS) will be defined as time from initiation of therapy to death, or censored at last follow-up date if the Patient is alive and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate OS with 95% CI. |
| Secondary | Progression-Free Survival (PFS) | up to 2 years | Progression free survival (PFS) will be defined as the time from initiation of therapy to the time of RECIST progression or death and will be calculated based on modified RECIST version 1.1 and iRECIST. Kaplan-Meier methods will be used to estimate PFS with 95% CI. |
| Secondary | Duration of Response (DOR) | up to 2 years | DOR is defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis will be censored at the date of their last tumor assessment. Per RECIST 1.1 |
| Secondary | Adverse events | up to 2 years | Adverse events and toxicity will be assessed according to the NCI-CTCAE 5.0 criteria. Medical review of adverse events and laboratory values will be conducted, and a safety assessment will be completed. Safety assessments will be conducted for all subjects receiving the study drug, with evaluation starting from the date of informed consent signing and continuing until the study concludes or 30 days after drug discontinuation. |
| Secondary | Skin adverse reactions | up to 2 years | Incidence of hand foot syndrome,, maculopapular rash, itching, urticaria, and pigmentation Skin rash and erythema NCI CTCAE level severity Dermatology Quality of Life Questionnaire (DLQI) |
| Secondary | Biomarker analysis | up to 2 years |
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/NCT06636981
GET https://conductscience.org/api/trials/v1/NCT06636981/registered