A Randomized, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- TQB2102 for Injection
- Conditions
- Breast Cancer
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 542
- Locations
- 34
- Primary Endpoint
- Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects voluntarily enrolled in this study with good compliance;
- •Age: 18-75 years old; Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1;
- •Pathologically confirmed locally advanced or metastatic breast cancer with low HER2 expression and unresectable:
- •Defined hormone receptor (HR) status.
- •Imaging-confirmed disease progression (during or after completion of the most recent treatment);
- •Have at least one measurable lesion according to RECIST 1.1 criteria;
- •Good major organ function.
Exclusion Criteria
- •The presence or current concurrent presence of other malignant tumors within 5 years prior to randomization. ;
- •Unresolved toxic reactions above Common Terminology Criteria for Adverse Events (CTC AE) grade 1 due to any prior therapy;
- •Major surgical treatment, incisional biopsy, or significant traumatic injury within 28 days prior to the start of the pre-randomization period;
- •Prolonged unhealed wounds or fractures;
- •Previous history of interstitial lung disease/pneumonia requiring steroidal drug intervention;
- •The presence of moderate to severe pulmonary dysfunction/disease within 3 months prior to randomization;
- •The presence of an arterial/deep vein thrombotic event within 6 months prior to randomization;
- •The presence of a medical condition that interferes with intravenous administration, intravenous blood collection, or inability to swallow, chronic diarrhea, intestinal obstruction, or the presence of other factors that interfere with the administration and absorption of medications;
- •The presence of grade ≥2 myocardial ischemia or myocardial infarction, cardiac arrhythmias (including QT corrected (QTc) ≥450ms (men) and QTc ≥470ms (women)) and grade ≥2 congestive heart failure (New York Heart Association (NYHA) classification); angina pectoris requiring antianginal medication; and clinically significant heart valve disease;
- •Active or uncontrolled ≥ CTC AE grade 2 infection present within 14 days prior to randomization;
Arms & Interventions
TQB2102 for Injection
Administered by intravenous drip, 7.5 mg/kg per dose, 21 days as a treatment cycle.
Intervention: TQB2102 for Injection
Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)
Based on each patient's condition and previous treatment history, the investigator will select one of the following chemotherapy drugs for treatment. * Capecitabine * Paclitaxel * Albumin Paclitaxel
Intervention: Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)
Outcomes
Primary Outcomes
Progression-free survival (PFS) in subjects with HR-positive, HER2 low-expressing recurrent/metastatic breast cancer as assessed by Independent Review Committee (IRC)
Time Frame: Up to 25 months
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.
Secondary Outcomes
- Progression-free survival (PFS) as assessed by investigators in the HER2 low expression population(Up to 25 months)
- Immunogenicity of TQB2102: ADA incidence(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.)
- Blood concentrations of the ADC drug TQB2102, total antibodies, and the small molecule toxin TQ22723(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).)
- Progression-free survival (PFS) in subjects with HER2 low-expressing recurrent/metastatic breast cancer as assessed by IRC(Up to 25 months)
- Progression-free survival (PFS) as assessed by investigators in the HR-positive, HER2 low-expressing population(Up to 25 months)
- Investigator-assessed overall survival (OS) in HR-positive, low HER2-expressing population.(Up to 25 months)
- Overall survival (OS) as assessed by investigators in the HR-positive, HER2 low-expressing population(Up to 25 months)
- Duration of remission (DOR) as assessed by investigators in the HR-positive, HER2 low-expressing population(Up to 25 months)
- Investigator-assessed clinical benefit rate (CBR) in the HR-positive, low HER2-expressing population(Up to 25 months)
- Overall survival (OS) as assessed by investigators in the HER2 low expression population(Up to 25 months)
- Duration of remission (DOR) as assessed by investigators in the HER2 low expression population(Up to 25 months)
- Objective remission rate (ORR) as assessed by investigators in the HER2 low expression population(Up to 25 months)
- Clinical benefit rate (CBR) as assessed by investigators in the HER2 low expression population(Up to 25 months)
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests(Up to 52 months)