Pre-surgery serplulimab with weekly paclitaxel and carboplatin for triple-negative breast cancer
NEOadjuvant SERplulimab Plus Weekly PaclitaxEl and carboplatiN in Triple-negative Breast Cancer: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Trial
PHASE2 · RenJi Hospital · NCT07283692
This trial tests whether adding serplulimab to weekly paclitaxel and carboplatin before surgery helps people with triple-negative breast cancer respond better to treatment.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | RenJi Hospital (other) |
| Drugs / interventions | serplulimab |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07283692 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women aged 18 to 70 with non-metastatic triple-negative breast cancer (ER and PR <10%, HER2 negative), at least one measurable lesion, ECOG 0–1, and adequate organ function are the intended participants.
Not a fit: Patients with metastatic (stage IV) disease, hormone receptor–positive or HER2‑positive tumors, those who are pregnant or breastfeeding, or those unable to tolerate chemotherapy are unlikely to benefit from this neoadjuvant approach.
Why it matters
Potential benefit: If successful, adding serplulimab could increase the chance the tumor disappears before surgery and improve long-term outcomes.
How similar studies have performed: Other studies combining PD‑1/PD‑L1 immune checkpoint inhibitors with neoadjuvant chemotherapy in triple‑negative breast cancer have shown improved pathological complete response rates, supporting this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Shanghai
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Triple Negative Breast Cancer, breast cancer, neoadjuvant, serplulimab