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.
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.
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;
Parallel
SHR-A1811
DrugA HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A1921
DrugA TROP2-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A2009
DrugA HER3-directed ADC, via intravenous (into the vein) infusion per protocol.
SHR-A2102
DrugA Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.
Famitinib
DrugA VEGFR inhibitor administered orally per the protocol.
Fat Module Formula for Special Medical Purposes
Dietary supplementThis nutritional formulation is composed primarily of medium-chain triglycerides (MCT), which are metabolized by the liver to induce nutritional ketosis, thereby significantly elevating circulating levels of beta-hydroxybutyrate (BHB).
Trastuzumab (or biosimilar)
DrugAn anti-HER2 antibody, via intravenous (into the vein) infusion or subcutaneous per protocol.
9MW2821
DrugA Nectin4-directed ADC, via intravenous (into the vein) infusion per protocol.
Disitamab Vedotin (RC48)
DrugA HER2-directed ADC, via intravenous (into the vein) infusion per protocol.
Treatment of physician's choice (TPC)
DrugTreatment of physician's choice (TPC), such as nab-paclitaxel, carboplatin, gemcitabine, capecitabine, vinorelbine, eribulin, etc., with specific dosages and administration methods determined at the investigator's discretion.
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Treatment groupsSee each treatment group below.
Objective response rate (ORR)
Objective response rate (ORR), defined as best overall response of either complete or partial response, will be assessed among participants who start protocol therapy and have measurable disease at screening. Radiographic response will be assessed using RECIST 1.1 criteria as defined per protocol.
Progression Free Survival (PFS)
PFS based on Kaplan-Meier methodology will be defined as the time from randomization until the identification of disease progression or death, whichever occurs first. Subjects without disease progression or death at the time of analysis will be censored at the date of last disease evaluation.
Disease Control Rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of participants with CR, PR and stable disease (SD) for ≥ 4 weeks as the best overall response.
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) is defined as the proportion of participants with CR, PR and stable disease (SD) for ≥ 24 weeks as the best overall response.
Duration of Response (DOR)
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, or death due to any cause). Participants without reported events are censored at the last disease evaluation.
Exploration of translational research markers
The collected subjects' tumor tissues, paracancerous tissues, blood, and fecal samples will be used for discovering exploratory biomarkers (including but not limited to the expression of HER2, TROP2, HER3, Nectin4, etc.). The relationships between discovered biomarkers and subjects' disease status and treatment responses will also be investigated.
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