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

NCT07040644 | Not Yet Recruiting Phase 2

• 1 other identifier: CO-US-979-7331
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

PD-L1 Positive; Sacituzumab Govitecan; Toripalimab; Nab-Paclitaxel; Advanced Breast Cancer; Metastatic TNBC; Randomized Controlled Trial; Progression-Free Survival

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  Progression-Free Survival (PFS) is defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurs first, as assessed by investigators based on RECIST version 1.1 criteria.

  From randomization until disease progression or death, assessed up to 36 months

Secondary Outcomes (5)

• Overall Survival (OS)

  From randomization until death, assessed up to 48 months

• Objective Response Rate (ORR)

  From first dose to first confirmed response, assessed up to 36 months

• Duration of Response (DOR)

  From first response until progression or death, assessed up to 36 months

• Time to Response (TTR)

  From randomization to first response, assessed up to 36 months

• Incidence of Adverse Events and Serious Adverse Events

  From first dose until 30 days after last dose

Study Arms (2)

SG plus Toripalimab

EXPERIMENTAL

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.

Drug: Sacituzumab Govitecan (SG); Drug: Toripalimab

Nab-Paclitaxel plus Toripalimab

ACTIVE COMPARATOR

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.

Drug: Toripalimab; Drug: Nab-paclitaxel

Interventions

Sacituzumab Govitecan (SG) 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.

SG plus Toripalimab

Toripalimab 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; SG plus Toripalimab

Nab-paclitaxel 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.

Nab-Paclitaxel plus Toripalimab

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, 510120, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan; toripalimab; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-05

Locations

CN (1)