A Study of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel in PD-L1 Positive Advanced TNBC

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 2

Conditions: Triple Negative Breast Neoplasms

Treatments: Drug: Sacituzumab Govitecan (SG); Drug: Nab-paclitaxel; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT07040644

CO-US-979-7331

Details and patient eligibility

About

This is a multicenter, open-label, randomized phase II trial evaluating the efficacy and safety of sacituzumab govitecan plus toripalimab versus toripalimab plus nab-paclitaxel in patients with previously untreated, unresectable, locally advanced or metastatic triple-negative breast cancer (TNBC) that is PD-L1 positive.

Eligible patients will be randomized in a 1:1 ratio to receive either sacituzumab govitecan plus toripalimab or toripalimab plus nab-paclitaxel. Tumor response will be assessed by investigators according to RECIST v1.1 at baseline, every 6 weeks during the first year, and every 12 weeks thereafter.

The primary objective is to evaluate progression-free survival (PFS). Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to response (TTR), and safety profile according to NCI-CTCAE v5.0.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female patients aged ≥18 years.
• Histologically or cytologically confirmed triple-negative breast cancer (TNBC).
• Unresectable locally advanced or metastatic disease.
• PD-L1 positive (CPS ≥1 as assessed by central laboratory).
• No prior systemic treatment for advanced or metastatic TNBC.
• Measurable disease per RECIST v1.1.
• ECOG performance status of 0 or 1.
• Adequate hematologic, hepatic, and renal function.
• Willingness to provide informed consent.

Exclusion criteria

• Prior treatment with any anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies.
• Known active central nervous system metastases.
• Active autoimmune disease or history of autoimmune disorders requiring systemic treatment.
• Active infection requiring systemic therapy.
• Pregnancy or lactation.
• Other active malignancies requiring treatment within the past 5 years.
• History of severe hypersensitivity reactions to study drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

SG plus Toripalimab

Experimental group

Description:

Participants will receive sacituzumab govitecan at 10 mg/kg via IV infusion on Days 1 and 8 of each 21-day cycle, and toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.

Treatment:

Drug: Toripalimab

Drug: Sacituzumab Govitecan (SG)

Nab-Paclitaxel plus Toripalimab

Active Comparator group

Description:

Participants will receive toripalimab at 240 mg via IV infusion on Day 1 of each 21-day cycle, and nab-paclitaxel at 125 mg/m² via IV infusion on Days 1 and 8 of each cycle. Treatment continues until disease progression, unacceptable toxicity, or withdrawal.

Treatment:

Drug: Toripalimab

Drug: Nab-paclitaxel