DP303c in Patients With HER2-positive Advanced Breast Cancer

Launched by CSPC ZHONGQI PHARMACEUTICAL TECHNOLOGY CO., LTD. · Jun 4, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called DP303c for patients with HER2-positive advanced breast cancer, which is a type of breast cancer that has spread and cannot be surgically removed. The trial is not yet recruiting participants, but when it begins, it will look for adults aged 18 and older who have already tried at least two other treatments for their cancer and have evidence that their disease has worsened. To be eligible, participants will need to confirm that their cancer tests show they are HER2-positive, and they should have good overall health and organ function.

If you or someone you know qualifies for this trial, you can expect to receive the study medication and to be monitored closely by healthcare professionals. Participants will need to agree to use contraception if they are of childbearing age. It's important to note that certain health conditions, like heart issues or active infections, may prevent someone from participating. This trial aims to see if DP303c can help improve outcomes for patients with this specific type of breast cancer, contributing to future treatment options.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Voluntarily agree to participate in the study and sign the informed consent;
• • 2. Age≥18 years old;
• • 3. Patients with unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology;
• • 4. Confirmed to be HER2 positive by central lab (HER2-positive is defined as IHC 3+ or IHC 2+ with ISH positive);
• • 5. Received at least 2 lines of systemic therapy for unresectable locally advanced, recurrent, or metastatic diseases;
• • 6. Radiographic evidence of disease progression confirmed by the investigator during or after the most recent systemic treatment;
• • 7. At least one assessable lesion at the baseline;
• • 8. The Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
• • 9. Patients with adequate organ function;
• • 10. Life expectancy ≥ 12 weeks;
• • 11. Female and male patient of childbearing age must agree to take adequate contraceptive measures during the entire study period.
• Exclusion Criteria:
• • 1. Pregnant or breastfeeding women;
• • 2. History of any other malignant tumors within three years
• • 3. Has not recovered from adverse reactions caused by previous anti-tumor treatments to ≤ grade 1 or baseline (refer to NCI CTCAE 5.0);
• • 4. 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;
• • 5. 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;
• • 6. Major organ surgery (excluding needle biopsy) within 28 days before randomization;
• • 7. The cumulative amount of previous exposure to anthracyclines has reached the dosage;
• • 8. Untreated (including baseline findings) or unstable cerebral parenchymal metastasis, spinal cord metastasis or compression, and cancerous meningitis.
• • 9. History of LVEF \< 40%, symptomatic congestive heart failure (CHF),.
• • 10. Serious or uncontrolled cardiovascular disease;
• • 11. History of (non-infectious) interstitial lung disease/pneumonitis requiring steroid hormone therapy;
• • 12. Patients who currently have corneal diseases that require medication or surgical intervention;
• • 13. Peripheral neuropathy ≥ grade 3 (refer to NCI CTCAE 5.0);
• • 14. Active infections requiring intravenous antibiotics, antivirals, or antifungals within 2 weeks before randomization;
• • 15. Active hepatitis B or C;
• • 16. History of immunodeficiency diseases, including human immunodeficiency virus (HIV) positive;
• • 17. Known hypersensitivity or contraindication to the active ingredients or excipients of the study drugs;
• • 18. Treated with strong CYP3A inhibitors or strong CYP3A inducers before randomization;
• • 19. There are other circumstances that may interfere with the subject's participation in the study procedures or do not meet the subject's maximum benefit from participating in the study or affect the study results.