DP303c in Patients With HER2-positive Advanced Breast Cancer

NCT05901935 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SYSA1501-007
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study of DP303c in patients with HER2-positive advanced breast cancer.

Conditions

HER2-positive Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS) by BIRC

  PFS is evaluated by a Blinded Independent Review Committee (BIRC) according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.

  Up to approximately 5 years

Secondary Outcomes (5)

• Progression-free survival (PFS) by investigator

  Up to approximately 5 years

• Overall Survival (OS)

  Up to approximately 5 years

• Objective response rate (ORR)

  Up to approximately 5 years

• Duration of response (DoR)

  Up to approximately 5 years

• Incidence and severity of adverse events (AEs)

  Up to approximately 5 years

Study Arms (2)

DP303c

EXPERIMENTAL

Eligible patients will be treated with DP303c at 3.0 mg/kg every 3 weeks.

Drug: DP303c

Trastuzumab combined with vinorelbine/capecitabine

ACTIVE COMPARATOR

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.

Drug: Trastuzumab; Drug: Vinorelbine Tartrate; Drug: Capecitabine tablets

Interventions

DP303c DRUG

DP303c injection, 3.0 mg/kg, Q3W.

DP303c

Trastuzumab DRUG

IV, 6 mg/kg, D1, Q3W

Trastuzumab combined with vinorelbine/capecitabine

Vinorelbine Tartrate DRUG

IV, 25 mg/m\^2，D1、D8，Q3W

Trastuzumab combined with vinorelbine/capecitabine

Capecitabine tablets DRUG

PO 1000 mg/m\^2, bid, D1-D14, Q3W

Trastuzumab combined with vinorelbine/capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period.

You may not qualify if:

• 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;
• History of (non-infectious) interstitial lung disease/pneumonitis requiring steroid hormone therapy;
• Patients who currently have corneal diseases that require medication or surgical intervention;
• Peripheral neuropathy ≥ grade 3 (refer to NCI CTCAE 5.0);
• Active infections requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before randomization;
• Active hepatitis B or C;

Sponsors & Collaborators

• CSPC ZhongQi Pharmaceutical Technology Co., Ltd.: lead

MeSH Terms

Interventions

Trastuzumab; Vinorelbine; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Clinical Trials Information Group officer

CONTACT

86-0311-69085587; ctr-contact@cspc.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2023
• First Posted: June 13, 2023
• Study Start: July 1, 2023
• Primary Completion: January 1, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 13, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share