Triple Negative Breast Neoplasms
Conditions
Keywords
PD-L1 Positive, Sacituzumab Govitecan, Toripalimab, Nab-Paclitaxel, Advanced Breast Cancer, Metastatic TNBC, Randomized Controlled Trial, Progression-Free Survival
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.
Interventions
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.
DRUGToripalimab
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.
DRUGNab-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.
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | 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. |
| Objective Response Rate (ORR) | 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. |
| Duration of Response (DOR) | 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. |
| Time to Response (TTR) | 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. |
| Incidence of Adverse Events and Serious Adverse Events | 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. |
Countries
China
Outcome results
None listed