DP303c in Patients With HER2-positive Advanced Breast Cancer

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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

Eligibility criteria

Qualifiers

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);

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • DP303c
  • Trastuzumab
  • Vinorelbine Tartrate
  • Capecitabine tablets

Treatment groups

420 Participants
are divided into 2 treatment groups

Locations

This trial has no locations