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Not yet recruiting NCT07040644

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

Phase II Interventional Triple Negative Breast Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sacituzumab Govitecan (SG), Toripalimab, Nab-paclitaxel.
Who it may be relevant to
Registry conditions: Triple Negative Breast Neoplasms. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multi-center, Open-label, Randomized, Phase II Trial of Sacituzumab Govitecan Plus Toripalimab Versus Toripalimab Plus Nab-Paclitaxel as First-line Therapy in Patients With Unresectable, Locally Advanced or Metastatic Triple-Negative Breast Cancer

Overview

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.

Interventions

  • Drug 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.
  • 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.
  • 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.

Primary outcome measures

  • Progression-Free Survival (PFS) [Time frame: From randomization until disease progression or death, assessed up to 36 months]
Secondary outcome measures (5)
  • Overall Survival (OS) [Time frame: From randomization until death, assessed up to 48 months]
  • Objective Response Rate (ORR) [Time frame: From first dose to first confirmed response, assessed up to 36 months]
  • Duration of Response (DOR) [Time frame: From first response until progression or death, assessed up to 36 months]
  • Time to Response (TTR) [Time frame: From randomization to first response, assessed up to 36 months]
  • Incidence of Adverse Events and Serious Adverse Events [Time frame: From first dose until 30 days after last dose]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou

Identifiers

NCT: NCT07040644 · CO-US-979-7331

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗