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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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•Fudan University

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•1. The subjects voluntarily participate and sign a written informed consent form;
•2. Age ≥ 18 years old;
•3. For locally advanced inoperable or metastatic breast cancer confirmed by histology (according to AJCC 8th edition staging), the histology and pathology clearly showed that ER, PR, Her-2 were negative. If there was metastatic lesion pathology, the metastatic lesion histology and pathology should prevail. The definition of ER and PR negativity is: IHC ER\&lt;1%, IHC PR\&lt;1%. Her-2 negativity is defined as: immunohistochemical detection of Her-2 (-) or (1+), Her-2 (2+) must undergo FISH testing and the result is negative, Her-2 (-) or (1+) can choose to undergo FISH testing and the result is negative;
•4. According to RECIST 1.1 criteria for solid tumor evaluation, there must be at least one measurable lesion;
•5. Cohort 1: For locally advanced non operable or metastatic TNBC that has not been previously treated, intravenous chemotherapy and anti-tumor therapy may be used during previous neoadjuvant and/or adjuvant therapy stages, provided that the interval between the end of neoadjuvant and/or adjuvant therapy and the occurrence of recurrence/metastasis is ≥ 12 months; Cohort 2: Local late stage inoperable or metastatic TNBC with previous treatment failures of at least one line or above;
•6. All subjects should undergo tumor lesion biopsy during the screening period to obtain sufficient qualified tumor tissue specimens for retrospective biomarker analysis (including PD-L1 expression levels) in their cohort. If subjects are unable to undergo biopsy, they should provide tumor samples or unstained sections (3-5 μm) that have been fixed in formalin and embedded in paraffin (FFPE) closest to the start of the study treatment (up to 24 months) for corresponding biomarker analysis;
•7. The main organ function is good, the relevant examination indicators within 14 days before treatment meet the following requirements:
•Without blood transfusion, platelet count ≥ 100 × 10\^9/L, hemoglobin ≥ 90g/L, neutrophil count (ANC) ≥ 1.5 × 10\^9/L AST and ALT ≤ 2.5 x upper limit of normal (ULN), ≤ 5 x ULN if liver metastasis is present, total bilirubin ≤ 1.5 x ULN, serum creatinine (Cr) ≤ 1.5 ULN, or creatinine clearance rate ≥ 60mL/min (Cockcroft Gault formula)
•8. Expected survival period ≥ 3 months;
•9. ECOG PS score: 0-1 points;
+1 more criteria

Exclusion Criteria

•1. Individuals who have previously been treated with PD-1 or PD-L1 monoclonal antibodies; Participants in cohort 1 who have previously used albumin paclitaxel;
•2. Individuals known to be allergic to any of the drugs in the study;
•3. Patients who have hypersensitivity reactions to other vitamin A drugs;
•4. History of active autoimmune diseases requiring systemic treatment in the past 2 years (e.g. corticosteroids (dose ≤ 10mg/day, except for prednisone or other effective hormones) or immunosuppressive drugs);
•5. Diagnosed with immune deficiency or undergoing systemic steroid therapy (excluding doses ≤ 10mg/day of prednisone or other effective hormones) or any other form of immunosuppressive therapy within 7 days prior to enrollment;
•6. There are other known malignant tumors that have progressed or require active treatment in the past 5 years. Excluding malignant tumors that can be treated locally and have already been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, and cervical cancer in situ;
•7. Known to have active central nervous system (CNS) metastases;
•8. History of non infectious pneumonia requiring steroid hormone therapy;
•9. Active infections require systematic treatment;
•10. There are serious uncontrolled hypertension, diabetes and hyperlipidemia;
+9 more criteria

Locations (2)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, China

Key Dates

Start Date

November 4, 2024

Primary Completion Date

September 1, 2029

Completion Date

September 1, 2029

Last Updated

December 13, 2024

Enrollment

129

ESTIMATED participants

Conditions

Triple Negative Breast Cancer (TNBC)

Interventions

Cohort2: ATRA+Toripalimab+TPC

DRUG

Cohort1: ATRA+Toripalimab+chemo

DRUG

Contacts

Zhonghua Tao, MD

CONTACT

86 13774315805 drtaozhh@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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