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

NCT ID: NCT07040644

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2028-06-30

Brief Summary

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.

Conditions

Triple Negative Breast Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SG plus Toripalimab

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.

Group Type: EXPERIMENTAL

Sacituzumab Govitecan (SG)

Intervention Type: DRUG

Sacituzumab govitecan will be administered at 10 mg/kg via intravenous infusion on Days 1 and 8 of each 21-day cycle. The treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Toripalimab

Intervention Type: DRUG

Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Nab-Paclitaxel plus Toripalimab

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.

Group Type: ACTIVE_COMPARATOR

Toripalimab

Intervention Type: DRUG

Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel will be administered at 125 mg/m² via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Interventions

Sacituzumab Govitecan (SG)

Sacituzumab govitecan will be administered at 10 mg/kg via intravenous infusion on Days 1 and 8 of each 21-day cycle. The treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Intervention Type: DRUG

Toripalimab

Toripalimab will be administered at a fixed dose of 240 mg via intravenous infusion on Day 1 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Intervention Type: DRUG

Nab-paclitaxel

Nab-paclitaxel will be administered at 125 mg/m² via intravenous infusion on Days 1 and 8 of each 21-day cycle. Treatment continues until disease progression, unacceptable toxicity, or patient withdrawal.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Countries

China

Facility Contacts

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Role: primary

jiangzefei@csco.org.cn

+86 20 8133 2536

Other Identifiers

CO-US-979-7331

Identifier Type: -

Identifier Source: org_study_id