RecruitingPhase 2NCT06636981

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


Sponsor

Fudan University

Enrollment

129 participants

Start Date

Nov 4, 2024

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding all-trans retinoic acid (ATRA), a vitamin A-related drug, to the immunotherapy drug toripalimab plus chemotherapy helps people with triple-negative breast cancer (TNBC) that is locally advanced or has spread to other parts of the body. **You may be eligible if...** - You are 18 or older with confirmed locally advanced or metastatic triple-negative breast cancer (ER, PR, and HER2 negative) - You have at least one measurable tumor - You have not been previously treated (Cohort 1) OR have had at least one prior treatment that failed (Cohort 2) - If previously treated with chemo, the cancer came back more than 12 months after finishing adjuvant therapy - Your blood counts, liver, and kidney function are within acceptable ranges **You may NOT be eligible if...** - You have active brain metastases or serious neurological problems - You have a prior history of immunotherapy-related severe side effects - You are pregnant or breastfeeding - You have uncontrolled heart disease or serious infections Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCohort2: 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.

DRUGCohort1: 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.


Locations(2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06636981


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