A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Po… (NCT06126640) | Clinical Trial Compass
RecruitingPhase 3
A Phase III, Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants With Residual Invasive Disease Following Neoadjuvant Therapy
China1,600 participantsStarted 2023-11-20
Plain-language summary
This study aims to Active-Controlled Study of SHR-A1811 Versus Trastuzumab Emtansine (T-DM1) in HER2-Positive Primary Breast Cancer Participants with Residual Invasive Disease Following Neoadjuvant Therapy，This study will examine SHR-A1811versus trastuzumab emtansine (T-DM1) in patients with HER2-positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes after neoadjuvant therapy.The primary objective is to compare invasive disease-free survival (IDFS) between SHR-A1811 and T-DM1 treatment arms in this population. The key secondary objective of the study is to evaluate disease-free survival (DFS), overall survival (OS) and distant recurrence-free interval (DRFI).
Who can participate
Age range18 Years – 75 Years
SexFEMALE
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Inclusion criteria
✓. The age is 18-75 years old (including both ends), and female
✓. HER2 positive invasive breast cancer Confirmed by pathological examination
✓. Clinical Stage before Neoadjuvant Therapy was T1-4, N0-3, M0 (excluding T1N0).
✓. Residual invasive cancer confirmed by pathological examination after radical surgery must meet one of the following two conditions:
✓. Previous neoadjuvant therapy must meet all of the following conditions:
✓. Have received radical surgery for breast cancer:
✓. The interval from the completion of radical surgery to the first random medication should be at least 3 weeks and no more than 12 weeks.
✓. Hormone receptor (HR) status was confirmed by postoperative pathologic examination. HR positive is defined as positive for the estrogen receptor (ER) or progesterone receptor (PR), and HR negative is defined as negative for both ER and PR.
Exclusion criteria
What they're measuring
1
Invasive disease-free survival (IDFS)
Timeframe: Randomization until the disease progressed, up to approximately 77 months postdose
✕. Evidence of recurrent breast cancer, including local recurrence, regional recurrence and distant metastasis .
✕. In the past 5 years, patients suffered from other malignant tumors, excluding cured basal cell carcinoma of skin andcervical carcinoma in situ,.
✕. Previously received systemic anti-HER2-ADC drug therapy, including but not limited to trastuzumab emtansine (T-DM1), Trastuzumab Deruxtecan (T-DXd), etc.
✕. Previous dosage requirements for anthracycline exposure meet one of the following conditions:
✕. History of cardiovascular diseases with clinical significance, such as severe/unstable angina pectoris, symptomatic congestive heart failure (NYHA ≥ Ⅱ), supraventricular or ventricular arrhythmia with clinical significance and requiring treatment or intervention, and myocardial infarction within 6 months.
✕. Subjects with known or suspected interstitial pneumonia.
✕. Known hereditary or acquired bleeding and thrombosis tendency.