Actively Recruiting

Phase 3
Age: 18Years - 80Years
FEMALE
NCT06313463

Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2024-03-15

375

Participants Needed

1

Research Sites

613 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients. The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy.

CONDITIONS

Official Title

Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy

Who Can Participate

Age: 18Years - 80Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent form.
  • Female patients aged 6518 years.
  • Adequate cognitive ability and willingness to comply with study plans.
  • Histologically confirmed invasive breast cancer.
  • Clinical stages cT4/any N/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (excluding cT1mi/T1a/T1b/N0).
  • TNBC diagnosis with TLS and PD-L1 status confirmed centrally.
  • Patients with synchronous bilateral invasive disease or multicentric tumors if all lesions are TNBC and TLS-positive.
  • Largest lesion measured for T stage in multifocal or multicentric breast cancer.
  • TLS presence confirmed by specific staining methods.
  • Completed preoperative systemic chemotherapy and camrelizumab treatment.
  • No pathological complete response after neoadjuvant therapy.
  • Complete removal of all clinically evident breast and lymph node lesions.
  • Surgery to randomization interval not exceeding 12 weeks.
  • ECOG performance status of 0 or 1.
  • LVEF 6550% post-neoadjuvant therapy with limited decrease from pre-chemotherapy.
  • Life expectancy of at least 6 months.
  • Adequate hematological and organ function.
  • Negative HIV test or stable HIV with criteria met.
  • Negative hepatitis B surface antigen.
  • Negative hepatitis C antibody or RNA as applicable.
  • Agreement to use contraception or abstinence for women of childbearing potential.
Not Eligible

You will not qualify if you...

  • Stage IV (metastatic) breast cancer.
  • Inadequate surgical resection.
  • Disease progression after preoperative systemic therapy.
  • Contraindications to radiotherapy for breast cancer.
  • Other malignancies within 5 years except certain treated cancers.
  • Prior use of CD137 agonists or immune checkpoint inhibitors.
  • Current grade 2 or higher peripheral neuropathy.
  • Dyspnea at rest.
  • Cardiopulmonary dysfunction.
  • Autoimmune disease or immunodeficiency history.
  • Idiopathic pulmonary fibrosis or related pneumonia conditions.
  • Active tuberculosis.
  • Severe uncontrolled systemic diseases.
  • Active liver diseases like autoimmune hepatitis.
  • Major surgery within 4 weeks before randomization (except breast cancer surgery).
  • Severe infection within 4 weeks before randomization.
  • Recent therapeutic antibiotic use.
  • Prior allogeneic bone marrow or solid organ transplantation.
  • Contraindications to study drugs or related health risks.
  • Recent live attenuated vaccine use or need during study.
  • Recent experimental treatment within 28 days before randomization.
  • Recent use of systemic immunostimulatory or immunosuppressive agents.
  • Severe hypersensitivity to antibodies or drug components.
  • Pregnancy, lactation, or planning pregnancy within 6 months post-treatment.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

S

Shicheng Su

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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