A Clinical Study of the Efficacy and Safety of Chidamide in Combination With Camrelizumab and Carboplatin or Capecitabine in the Second and Third Line Treatment of Relapsed/Metastatic Triple-negative Breast Cancer

Sponsor
Fudan University
Study ID
NCT05438706
Phase
PHASE2
Status
Unknown

Conditions

  • Triple-negative Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • chidamide — DRUG
    Chidamide, an HDAC inhibitor
  • camrelizumab — DRUG
    Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd, recently received conditional approval in China for the treatment of relapsed or refractory classical Hodgkin lymphoma. The drug is also being investigated as a treatment for various other malignancies, including B cell lymphoma, oesophageal squamous cell carcinoma, gastric/gastroesophageal junction cancer, hepatocellular carcinoma, nasopharyngeal cancer and non-squamous, non-small cell lung cancer.
  • carboplatin — DRUG
    Carboplatin \[diammine(1,1-cyclobutanedicarboxylato)platinum(II)\] is one of the most promising second generation platinum compounds. Its greater chemical stability in comparison with cisplatin accounts for its lower reactivity with nucleophilic sites of DNA.
  • capecitabine — DRUG
    Capecitabine is an oral prodrug of 5-fluorouracil (5-FU) and approved for treatment of various malignancies. Hereditary genetic variants may affect a drug's pharmacokinetics or pharmacodynamics and account for differences in treatment response and adverse events among patients.

Study Details

To evaluate the efficacy and safety of chidamide in combination with camrelizumab and carboplatin or capecitabine in the second and third line treatment of relapsed/metastatic triple-negative breast cancer

Key Dates

Start date
Jul 10, 2022
Status verified
Jun 2022
Primary completion
Nov 10, 2023
Completion
Jul 10, 2024

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    chidamide in combination with camrelizumab and capecitabine
  • Experimental: Arm 2
    chidamide in combination with camrelizumab and carboplatin

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to approximately 12 weeks ]

Central Contacts

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