Combination therapy for advanced triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Beijing Cancer Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Guohong Song, Doctor of Medicine (M.D.)
• Email: songguohong918@hotmail.com
• Phone: 0086-88121122-2066

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neoadjuvant Cryo-Thermal Ablation with Toripalimab and Chemo for Resectable NSCLC

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.