Pre-surgery serplulimab with weekly paclitaxel and carboplatin for triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, open-label, multicenter phase 2 trial giving serplulimab together with weekly paclitaxel and carboplatin in the neoadjuvant setting for triple-negative breast cancer. It enrolls adult women (18–70) with histologically confirmed ER <10%, PR <10%, and HER2-negative tumors who have at least one evaluable lesion and ECOG performance status 0–1. Patients receive the combination regimen prior to surgery and are monitored for safety, tolerability, and anti-tumor activity with imaging and pathology assessments. The study is led by RenJi Hospital, Shanghai Jiao Tong University School of Medicine.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female, Aged ≥18 and ≤70 years
* Histologically confirmed triple negative breast cancer (ER\<10%, PR\<10%, and HER2 negative)
* Subjects with at least one evaluable lesion
* ECOG 0-1
* Adequate organ function

Exclusion Criteria:

* Metastatic disease (Stage IV)
* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period

Where it's running

• Renji Hospital, School of Medicine, Shanghai Jiaotong University
  Shanghai, China Recruiting

Study contacts

• Principal investigator: Wenjin Yin, M.D. — Renji Hospital,School of Medicine, Shanghai Jiaotong University
• Study coordinator: Wenjin Yin, M.D.
• Email: yinwenjin@renji.com
• Phone: 86(21)68385569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.