Actively Recruiting

Phase 2
Age: 18Years - 65Years
FEMALE
NCT06817525

Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC

Led by Henan Cancer Hospital · Updated on 2025-12-05

64

Participants Needed

1

Research Sites

81 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

We plan to explore the efficacy and safety of albumin-bound paclitaxel+carboplatin+Camrelizumab in neoadjuvant therapy for early TNBC patients, optimize the administration method and drug combination therapy.

CONDITIONS

Official Title

Nab-P+Cb+PD1 Inhibitors as Neoadjuvant Therapy for Early TNBC

Who Can Participate

Age: 18Years - 65Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female aged 18 to 65 years
  • Diagnosed with clinical T2 to T4d or T1c breast cancer with axillary lymph node metastasis
  • Confirmed triple-negative invasive breast cancer by histopathology (ER and PR negative, HER-2 negative)
  • Measurable lesions by ultrasound, mammography, or optional MRI within 1 month before screening
  • Adequate organ and bone marrow function within 2 weeks before chemotherapy
  • Cardiac ultrasound ejection fraction at least 55%
  • Negative pregnancy test for women of childbearing age within 14 days before randomization
  • ECOG performance status of 0 or 1
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • Evidence of metastatic breast cancer confirmed by imaging before diagnosis and randomization
  • Prior chemotherapy, endocrine therapy, targeted therapy, or radiation for this breast cancer
  • Second primary malignant tumor except fully treated skin cancer
  • Previous treatment with anti-PD-1, anti-PDL1, anti-PD-L2, or other immunotherapy
  • Diagnosed with immunodeficiency or autoimmune diseases
  • Severe lung or heart disease
  • Active hepatitis B or C infection
  • History of organ or bone marrow transplantation
  • Pregnant or breastfeeding women
  • Serious medical conditions contraindicating chemotherapy
  • Significant bleeding symptoms or bleeding tendency in the previous month
  • Arteriovenous thrombosis events like deep vein thrombosis or pulmonary embolism within the previous 3 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Henan cancer hospital

Zhengzhou, Henan, China

Actively Recruiting

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Research Team

Z

Zhenzhen Liu

CONTACT

Y

Yajie Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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