Combination therapy for advanced triple-negative breast cancer

A Prospective, Single-arm, Multicenter Phase II Clinical Study of Sacituzumab Govitecan in Combination With Toripalimab as First-line Treatment for Advanced Triple-negative Breast Cancer and an Exploratory Study of Biomarkers for Predicting Efficacy

This study is testing a new combination of two drugs to see if it can help people with advanced triple-negative breast cancer live longer and feel better.

Quick facts

• Study type: Observational
• Enrollment: 51 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Peking University Cancer Hospital & Institute (other)
• Drugs / interventions: sacituzumab, toripalimab, chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT06991790 on ClinicalTrials.gov

What this trial studies

This study explores the efficacy and safety of sacituzumab govitecan combined with toripalimab as a first-line treatment for patients with advanced triple-negative breast cancer (TNBC). It aims to evaluate progression-free survival and monitor adverse events to assess safety under real-world conditions. Additionally, the study seeks to identify biomarkers that may predict the treatment's efficacy. Participants will have their response rates and survival periods tracked as secondary outcomes.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 75 with histologically confirmed advanced triple-negative breast cancer who have not received prior systemic treatment.

Not a fit: Patients with symptomatic brain metastases or those who have previously received HER2-targeted or PD-(L)1 therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective first-line therapy option for patients with advanced triple-negative breast cancer.

How similar studies have performed: While this approach is novel in combining these specific therapies for TNBC, similar studies have shown promise in exploring combination therapies for cancer treatment.

Eligibility criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with symptomatic brain metastases (such as increased intracranial pressure, epilepsy, etc.) who require emergency radiotherapy or surgical intervention;
2. Patients who have previously received HER2-targeted therapy or Trop-2-targeted therapy;
3. 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;
4. Patients who are considered by the investigator to be unsuitable for participating in this study.

Where this trial is running

Beijing

• Beijing Cancer Hospital — Beijing, China (RECRUITING)

Study contacts

• Study coordinator: Guohong Song, Doctor of Medicine (M.D.)

Conditions: TNBC, sacituzumab govetican, toripalimab, ADC, triple-negative breast cancer, first-line therapy, immune-checkpoint inhibitor