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DP303c in Patients With HER2-positive Advanced Breast Cancer

ConditionHER2-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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • DP303c

    Drug

    DP303c injection, 3.0 mg/kg, Q3W.

  • Trastuzumab

    Drug

    IV, 6 mg/kg, D1, Q3W

  • Vinorelbine Tartrate

    Drug

    IV, 25 mg/m\^2，D1、D8，Q3W

  • Capecitabine tablets

    Drug

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

Treatment groups

420 Participants
are divided into 2 treatment groups
Group A: DP303cExperimental treatment 1 intervention
Group B: Trastuzumab combined with vinorelbine/capecitabineActive comparator 3 interventions

Trial outcomes

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.

Time frame
Up to approximately 5 years

Secondary outcomes

1

Progression-free survival (PFS) by investigator

PFS is evaluated by investigator according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.

Time frame
Up to approximately 5 years
2

Overall Survival (OS)

Overall Survival

Time frame
Up to approximately 5 years
3

Objective response rate (ORR)

ORR is evaluated by investigator and BIRC according to the Response Evaluation Criteria for Solid Tumors (RECIST) V1.1.

Time frame
Up to approximately 5 years
4

Duration of response (DoR)

Duration of Response

Time frame
Up to approximately 5 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: