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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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2024-12-13

No results posted yet for this study

Summary

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

Conditions

  • Triple Negative Breast Cancer (TNBC)

Interventions

DRUG

Cohort2: ATRA+Toripalimab+TPC

Receive 200 mg D1 of Toripalimab via intravenous infusion for a course of 21 days; TPC regimen (monoclonal antibody 10mg/kg D1, 8 intravenous infusions, 1 course of treatment every 21 days; Elibulin 1.4mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Utideron 40mg/m2 D1-5 intravenous infusions, 1 course of treatment every 21 days; Gemcitabine 1000mg/m2 D1, 8 intravenous infusions, 1 course of treatment every 21 days; Albumin paclitaxel 100 mg/m2 D1, D8, intravenous infusion, 1 course of treatment every 21 days); Capecitabine 1000mg/m2, D1-14, oral, one course of treatment every 21 days); All trans retinoic acid 20 mg bid, orally, D-3-D11, administered continuously for 14 days, stopped for 7 days, with one course of treatment lasting 21 days.

DRUG

Cohort1: ATRA+Toripalimab+chemo

Receive 200 mg of Toripalimab via D1 intravenous infusion, with 21 days as one course of treatment; Albumin paclitaxel 100 mg/m2, D1, D8, intravenous infusion, one course of treatment for 21 days; All trans retinoic acid 20 mg bid, oral, D-3-D11, continuous administration for 14 days, cessation for 7 days, 21 days is one course of treatment.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-04
Primary Completion
2029-09-30
Completion
2029-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06636981 on ClinicalTrials.gov