Platform Study of ADC Rechallenge in ADC-treated Metastatic Breast Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

This is a prospective, open-label, phase 2 platform trial. The purpose of this study is to test the safety and effectiveness of the antibody-conjugated drugs (ADCs) in patients with advanced breast cancer who had previously used antibody-conjugated drugs.

Eligibility criteria

Qualifiers

Age ≥18 years;

Locally advanced breast cancer (unable to undergo radical local treatment) or recurrent metastatic breast cancer;

Previously received ADCs;

The most recent pathology results will be considered for enrollment according to local testing of ER, PR and HER2. Participants with any hormone receptor (HR) status will be allowed on study.

Disqualifiers

Radiotherapy (except for palliative causes), chemotherapy, and immunotherapy were used in the first 3 weeks of treatment, except bisphosphonate (which can be used for bone metastasis);

Uncontrolled central nervous system metastases (indicating symptomatic or symptomatic treatment with glucocorticoids or mannitol);

A history of clinically important or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmia within the last 6 months;

Presence of the third space effusion (such as massive ascites, pleural effusion, pericardial effusion) that cannot be controlled by drainage or other methods;

Trial design

Treatments tested in this trial

  • SHR-A1811
  • SHR-A1921
  • SHR-A2009
  • SHR-A2102
  • Famitinib
  • Fat Module Formula for Special Medical Purposes
  • Trastuzumab (or biosimilar)
  • 9MW2821

Treatment groups

160 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators