PD-1 Inhibitor Concurrent With Chemotherapy as Neoadjuvant Therapy for TNBC (NeoPD1TNBC)

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Triple Negative Breast Cancer

Treatments: Drug: Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04809779

2020466

Details and patient eligibility

About

The purpose of the study is to address the following hypotheses: the PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments. This regimen will induce higher pathologic complete response (pCR) rate in triple negative breast cancer than historical pCR rates (30-40%) observed with chemotherapy alone.

Enrollment: 49 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed histologically confirmed stage I-III, ER, PR and HER2 negative invasive breast cancer as defined by the ASCO CAP guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard NCCN practice guidelines.

Exclusion criteria

• Patients for whom anthracycline, nab-paclitaxel or antibody therapies are contraindicated.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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49 participants in 1 patient group

Sintilimab

Experimental group

Treatment:

Drug: Sintilimab