A Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
NCT Number: NCT06561607
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Breast Cancer
Interventions: DRUG: TQB2102 for Injection|DRUG: Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 542
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2028-12
Locations: The First Affiliated Hospital of Bengbu Medical University, Bengbu, Anhui, 233004, China|AnHui Province Hospital West District, Hefei, Anhui, 230000, China|The first Affiliated hospital of anhui medical university, Hefei, Anhui, 230000, China|Beijing Cancer Hospital, Beijing, Beijing, 100142, China|Fujian Medical University 2nd Affiliated Hospital, Quanzhou, Fujian, 362000, China|Zhangzhou Hospital in Fujian Province, Zhangzhou, Fujian, 363000, China|Gansu Provincial Hospital, Lanzhou, Gansu, 730000, China|Gansu Provincial Cancer Hospital, Lanzhou, Gansu, 730050, China|Gansu Wuwei Tumour Hospital, Wuwei, Gansu, 730000, China|Sun Yet-Sen University Cancer Certer, Guangzhou, Guangdong, 510000, China|Affiliated Hospital of Guangdong Medical University, ZhanJiang, Guangdong, 524001, China|Guigang City People'S Hospital, Guigang, Guangxi, 537100, China|Cancer Hospital Affiliated to Guangxi Medical University, Nanning, Guangxi, 530021, China|The First affiliated hospital of GuangXi medical university, Nanning, Guangxi, 530021, China|The Affiliated Cancer Hospital of Guizhou Medical University Co., LTD, Guiyang, Guizhou, 550000, China|Guizhou Provincial People's Hospital, Guiyang, Guizhou, 550002, China|The First Affiliated Hospital of Hainan Medical College, Haikou, Hainan, 570102, China|Hainan General Hospital, Haikou, Hainan, 570311, China|Affiliated Hospital of Hebei University, Baoding, Hebei, China|Chengde Central Hospital, Chengde, Hebei, 067024, China|Affiliated Cancer Hospital of Harbin Medical University, Harbin, Heilongjiang, 150081, China|AnYang Tumor Hospital, Anyang, Henan, 455100, China|Henan Cancar Hospital, Zhengzhou, Henan, 450000, China|The First Affiliated Hospital of Henan University of Science & Technology, Luoyang, Hennan, 471003, China|Tongji Hospital Tongji Medical College of HUST, Wuhan, Hubei, 430034, China|Hubei Cancer Hospital, Wuhan, Hubei, 430079, China|Chifeng Municipal Hospital, Chifeng, Inner Mongolia, 24099, China|The Second Hospital of DALIAN Medical University, Dalian, Liaoning, 116000, China|Binzhou Medical College Affiliated Hospital, Binzhou, Shandong, 256699, China|Binzhou People's Hospital, Binzhou, Shandong, 310053, China|Obstetrics & Gynecology Hospital of Fudan University, Shanghai, Shanghai, 200082, China|Baoji Central Hospital, Baoji, Shanxi, 721008, China|Affiliated Hospital of North Scichuan Medical College, Nanchong, Sichuan, 637000, China|Affiliated Hangzhou First People's Hospital, Hangzhou, Zhejiang, 310004, China

Summary:
The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent metastatic stage who have not received chemotherapy. The primary objective of the study is to determine the efficacy and safety of TQB2102 compared to investigator-selected single-agent chemotherapy in the target population. 542 subjects with HER2 immunohistochemistry (IHC )2+/ in situ hybridization (ISH)- and IHC 1+ (HER2-low) expression will be enrolled in 1:1 randomized groups to receive TQB2102 or investigator's choice of single-agent chemotherapy (capecitabine, paclitaxel, or albumin-paclitaxel) until progression of disease (PD), as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1. 1, unless there are unacceptable toxicity, withdrawal of consent, or meeting other discontinuation criteria.

Primary Outcome Measures: Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC), Designed to demonstrate that in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy., Up to 25 months
Secondary Outcome Measures: Progression-free survival (PFS) in subjects with HER2 low-expressing recurrent/metastatic breast cancer as assessed by IRC, Designed to demonstrate that in subjects with HER2 low-expressing recurrent/metastatic breast cancer, TQB2102 for injection significantly prolongs progression-free survival in subjects compared to investigator-selected chemotherapy., Up to 25 months|Progression-free survival (PFS) as assessed by investigators in the HR-positive, HER2 low-expressing population, To evaluate progression-free survival (PFS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Investigator-assessed overall survival (OS) in HR-positive, low HER2-expressing population., To evaluate the overall survival (OS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Overall survival (OS) as assessed by investigators in the HR-positive, HER2 low-expressing population, To evaluate the objective remission rate (ORR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Duration of remission (DOR) as assessed by investigators in the HR-positive, HER2 low-expressing population, To evaluate the duration of remission (DOR) of injectable TQB2102 compared to investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Investigator-assessed clinical benefit rate (CBR) in the HR-positive, low HER2-expressing population, To evaluate the clinical benefit rate (CBR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Progression-free survival (PFS) as assessed by investigators in the HER2 low expression population, To evaluate progression-free survival (PFS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Overall survival (OS) as assessed by investigators in the HER2 low expression population, To evaluate the overall survival (OS) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Duration of remission (DOR) as assessed by investigators in the HER2 low expression population, To evaluate the duration of remission (DOR) of injectable TQB2102 compared to investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Objective remission rate (ORR) as assessed by investigators in the HER2 low expression population, To evaluate the objective remission rate (ORR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Clinical benefit rate (CBR) as assessed by investigators in the HER2 low expression population, To evaluate the clinical benefit rate (CBR) of TQB2102 for injection versus investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer., Up to 25 months|Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests, To evaluate the safety of TQB2102 for Injection compared to investigator-selected chemotherapy in subjects with HER2 low-expressing recurrent/metastatic breast cancer, including: the incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs)., Up to 52 months|Blood concentrations of the ADC drug TQB2102, total antibodies, and the small molecule toxin TQ22723, To evaluate the pharmacokinetic (PK) profile of TQB2102 for injection in subjects with HER2 low-expressing recurrent/metastatic breast cancer.

Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 ., Within 1 hour prior to the start of infusion for Cycle 1, Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12, and 0.5 to 2 hours after the end of infusion for Cycle 2, Cycle 3, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle).|Immunogenicity of TQB2102: ADA incidence, To evaluate the immunogenicity (ADA) of TQB2102 for injection in subjects with HER2 low expression recurrent/metastatic breast cancer., Prior to (-60 min) the first day of dosing in Cycle 1, Cycle 2, Cycle 4, Cycle 7, and Cycle 12 (21 days as a treatment cycle), and at follow-up 30 days (±7 days) after the last dosing.