Sacituzumab Govitecan + Toripalimab as First - Line Therapy for Advanced Triple - Negative Breast Cancer and Biomarker Exploration

NCT06991790 | Recruiting

• 1 other identifier: Y-Gilead2024-ZD-0212
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to explore the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment in patients with advanced triple - negative breast cancer. The main questions it aims to answer are:

1. 1.To investigate the efficacy and safety of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.
2. 2.To explore the biomarkers that can predict the efficacy of sacituzumab govitecan in combination with toripalimab as first - line treatment for advanced triple - negative breast cancer.

Conditions

TNBC

Keywords

sacituzumab govetican; toripalimab; ADC; triple-negative breast cancer; first-line therapy; immune-checkpoint inhibitor

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

  PFS is defined as the time from the date of randomization until the date of objective progressive disease (PD) or death (whichever comes first).

  Enrollment up for approximately 36 months.

Secondary Outcomes (4)

• Overall Survival (OS)

  Enrollment up for approximately 53 months.

• Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  First dose date up to 30 days post last dose, up to approximately 53 months

• Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1

  Enrollment up for approximately 53 months.

• Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities

  First dose date up to 30 days post last dose, up to approximately 53 months

Study Arms (1)

Sacituzumab govitecan combined with Toripalimab

Drug: Sacituzumab Govitecan (SG)+Toripalimab

Interventions

Sacituzumab Govitecan (SG)+Toripalimab DRUG

Sacituzumab govitecan (Trodelvy): 10mg/kg, administered by intravenous infusion on day 1 and day 8. Toripalimab: 240mg, administered by intravenous infusion on day 1.

Also known as: IMMU-132, Trodelvy™, GS-0132, Toripalimab

Sacituzumab govitecan combined with Toripalimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving first-line treatment for advanced triple-negative breast cancer

You may qualify if:

• Female breast cancer patients aged 18 to 75 years old;
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0 to 1;
• Patients with histologically or cytologically confirmed advanced triple-negative breast cancer;
• Patients who have not received systemic treatment (including chemotherapy, targeted therapy and immunotherapy) for advanced triple-negative breast cancer;
• According to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 standard, having at least one measurable lesion;
• Deciding to receive anti-tumor treatment with the combination of sacituzumab govitecan and toripalimab.

You may not qualify if:

• Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;
• Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;
• Patients who have previously used or are currently using PD-(L)1 inhibitors and/or ADC drugs containing topoisomerase inhibitors, such as sacituzumab govitecan, Dato-DXd, etc., as well as topoisomerase inhibitors;
• Patients who are considered by the investigator to be unsuitable for participating in this study.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, 100142, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue specimens, peripheral blood specimens

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

sacituzumab govitecan; toripalimab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Guohong Song, Doctor of Medicine (M.D.)

CONTACT

0086-88121122-2066; songguohong918@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician, Deputy Director of the Department, Medical Oncology of Breast Cancer

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: May 28, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (1)