Combination therapy for residual triple-negative breast cancer after neoadjuvant treatment

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 is a randomized, open-label Phase 3 study evaluating Trastuzumab Rezetecan with Adebrelimab versus investigator’s choice therapy in patients with residual invasive triple-negative breast cancer following neoadjuvant treatment. The trial will also explore pharmacokinetics and immunogenicity of the study drugs. Participants will be adults with good performance status and adequate organ function, enrolled at multiple centers. Safety and efficacy outcomes will be compared to determine if the combination improves outcomes in this high-risk group.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Pathologically confirmed invasive triple negative breast cancer.
2. Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy.
3. Previous neoadjuvant therapy must meet the requirements of the protocol.
4. Has received radical surgery for breast cancer.
5. ECOG PS 0\~1.
6. Adequate organ functions.
7. Women of childbearing potential must be willing to use highly effective form of contraception.

Exclusion Criteria:

1. Stage IV metastatic breast cancer.
2. Previous invasive breast cancer or ductal carcinoma in situ.
3. Bilateral breast cancer.
4. Any clinical evidence indicating the exist of recurrent diseases after surgery.
5. History of other malignancy within the last 5 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ.
6. Previously received antibody coupled drug (ADC) therapy with topoisomerase inhibitors as effective payloads.
7. Previously received HER2 targeted therapy.
8. Active or previously recorded autoimmune or inflammatory diseases.
9. History of immunodeficiency.
10. Participants with known or suspected interstitial pneumonia.
11. Presence of active Hepatitis B.
12. Known to have active tuberculosis infection.
13. Uncontrolled infections requiring intravenous injection of antibiotics, antiviral drugs, or antifungal drugs for treatment.
14. Within the 6 months prior to randomization, there was a history of myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, ≥ Grade 2 supraventricular or ventricular arrhythmias, and any grade of ventricular fibrillation.
15. Known allergy to any investigational drug or its excipients.
16. Other medical conditions that would interfere with study participation or follow-up.

Where it's running

• Cancer Hospital of Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Zhiye Chen, M.M
• Email: zhiye.chen.zc78@hengrui.com
• Phone: +86-0518-82342973

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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.