A Randomized, Multicenter, Double-Blind, Parallel-Controlled, Phase III Clinical Study to Evaluate QL1209/Pertuzumab in Combination With Docetaxel in Patients With Early-Stage or Locally Advanced HER2-Positive and ER/PR-negative Breast Cancer.

QL1209-301

This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage or locally advanced HER2-positive and estrogen receptor/progesterone receptor negative breast cancer. The anticipated treatment duration is approximately 140 days.

2020-11-23

2022-08-22

2023-10-24

Completed

Early phase I

517

Inclusion Criteria: 1. Volunteer to participate in this clinical study; Completely understand and know this study as well as sign the informed consent form (ICF); 2. Age ≥ 18 years and ≤ 80 years when ICF is signed; 3. Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (\>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0); HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization; Estrogen receptor and Progesterone receptor negative. 4. Eastern Cooperative Oncology Group Performance Status equal to or less than (\<=) 1. 5. Baseline left ventricular ejection fracture \>= 55% measured by echocardiography (preferred) or multiple gated acquisition scan Exclusion Criteria: 1. Stage IV metastatic breast cancer; 2. Inflammatory breast cancer; 3. Previous anti-cancer therapy or radiotherapy for any malignancy; 4. History of malignancies other than colorectal cancer within 5 years prior to randomization, excluding cutaneous basal cell carcinoma, cervical carcinoma in situ, and thyroid papillary adenocarcinoma of non-melanoma after radical treatment; 5. Concurrent anti-cancer treatment in another investigational trial, including hormone therapy, bisphosphonate therapy, or immunotherapy; 6. Major surgical procedure within 4 weeks prior to randomization or from which the participant has not fully recovered; 7. Serious cardiac illness or medical condition; 8. Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness; 9. Sensitivity to any of the study medications, any of the ingredients or excipients of these medications, or benzyl alcohol; 10. Pregnant or lactating

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 517, 'type': 'ACTUAL'}}

2024-04-19