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NCT Number: NCT07040644

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

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.

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Key information

Conditions

Triple Negative Breast Neoplasms Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

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

Guangzhou, Guangdong, 510120, China

Location contact

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

CONTACT

[email protected]

+86 20 8133 2536

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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

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.

Primary outcomes

  1. Progression-Free Survival (PFS)

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

    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.

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: From randomization until death, assessed up to 48 months

    Overall Survival (OS) is defined as the time from randomization to death from any cause. The event will be recorded regardless of cause and assessed continuously until the end of study follow-up.

  2. Objective Response Rate (ORR)

    Time frame: From first dose to first confirmed response, assessed up to 36 months

    Objective Response Rate (ORR) is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR), confirmed at least 4 weeks after the initial response, as assessed by investigators according to RECIST version 1.1 criteria.

  3. Duration of Response (DOR)

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

    Duration of Response (DOR) is defined as the time from the first documentation of complete response (CR) or partial response (PR) until disease progression or death from any cause, whichever occurs first, as assessed by investigators according to RECIST version 1.1 criteria.

  4. Time to Response (TTR)

    Time frame: From randomization to first response, assessed up to 36 months

    Time to Response (TTR) is defined as the time from randomization to the first documentation of complete response (CR) or partial response (PR), as assessed by investigators according to RECIST version 1.1 criteria.

  5. Incidence of Adverse Events and Serious Adverse Events

    Time frame: From first dose until 30 days after last dose

    Incidence, type, and severity of adverse events (AEs) and serious adverse events (SAEs) will be assessed from the first dose through 30 days after the last dose, and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Jun 27, 2025
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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