A Multicentre, Randomized, Open-label, Controlled Phase Ш Clinical Study to Evaluate the Efficacy and Safety of DP303cversus Trastuzumab Combined With Vinorelbine/Capecitabine in of HER2-positive Advanced Breast Cancer
Overview
- Phase
- Phase 3
- Intervention
- DP303c
- Conditions
- HER2-positive Advanced Breast Cancer
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Enrollment
- 420
- Primary Endpoint
- Progression-free survival (PFS) by BIRC
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
Detailed Description
This is a multi-centre, randomized, open-label, controlled phase Ш clinical study to evaluate the efficacy and safety of DP303c injection versus trastuzumab combined with vinorelbine/capecitabine in the treatment of HER2-positive advanced breast cancer. Patients will be treated with DP303c injection at 3.0 mg/kg or trastuzumab combined with vinorelbine/capecitabine every 3 weeks. Patients will continue to receive treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death, or any other reasons for treatment discontinuation, whichever occurs first.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Voluntarily agree to participate in the study and sign the informed consent;
- •Age≥18 years old;
- •Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology;
- •Confirmed to be HER2 positive by central lab (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
- •Received at least 2 lines of systemic therapy for unresectable locally advanced, recurrent, or metastatic diseases;
- •Radiographic evidence of disease progression confirmed by the investigator during or after the most recent systemic treatment;
- •At least one assessable lesion at the baseline;
- •The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Patients with adequate organ function;
- •Life expectancy ≥ 12 weeks;
Exclusion Criteria
- •Pregnant or breastfeeding women;
- •History of any other malignant tumors within three years
- •Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0);
- •The presence of active inflammatory bowel disease, chronic diarrhoea, short bowel syndrome or history of other gastrointestinal diseases or treatments that may affect intestinal absorption;
- •Received systemic anti-tumor therapy within 28 days before randomization, traditional Chinese medicine treatment with tumor indications approved by the National Medical Administration (NMPA) and palliative radiotherapy within 2 weeks before randomization;
- •Major organ surgery (excluding needle biopsy) within 28 days before randomization;
- •The cumulative amount of previous exposure to anthracyclines has reached the dosage;
- •Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
- •History of LVEF \< 40%, symptomatic congestive heart failure (CHF),.
- •Serious or uncontrolled cardiovascular disease;
Arms & Interventions
DP303c
Eligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks.
Intervention: DP303c
Trastuzumab combined with vinorelbine/capecitabine
Eligible patients will be treated with trastuzumab IV on day 1 and oral capecitabine twice daily on days 1-14 every 3 weeks, or patients will be treated with trastuzumab IV on day 1 and vinorelbine IV over on days 1 and 8 every 3 weeks.
Intervention: Trastuzumab
Trastuzumab combined with vinorelbine/capecitabine
Eligible patients will be treated with trastuzumab IV on day 1 and oral capecitabine twice daily on days 1-14 every 3 weeks, or patients will be treated with trastuzumab IV on day 1 and vinorelbine IV over on days 1 and 8 every 3 weeks.
Intervention: Vinorelbine Tartrate
Trastuzumab combined with vinorelbine/capecitabine
Eligible patients will be treated with trastuzumab IV on day 1 and oral capecitabine twice daily on days 1-14 every 3 weeks, or patients will be treated with trastuzumab IV on day 1 and vinorelbine IV over on days 1 and 8 every 3 weeks.
Intervention: Capecitabine tablets
Outcomes
Primary Outcomes
Progression-free survival (PFS) by BIRC
Time Frame: Up to approximately 5 years
PFS is evaluated by a Blinded Independent Review Committee (BIRC) according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.
Secondary Outcomes
- Incidence and severity of adverse events (AEs)(Up to approximately 5 years)
- Progression-free survival (PFS) by investigator(Up to approximately 5 years)
- Duration of response (DoR)(Up to approximately 5 years)
- Overall Survival (OS)(Up to approximately 5 years)
- Objective response rate (ORR)(Up to approximately 5 years)