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A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer

ConditionHER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 combined with Pertuzumab versus docetaxel plus Trastuzumab and Pertuzumab in patients with first-line HER2-positive recurrent or metastatic breast cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily sign the informed consent form and comply with the protocol requirements;

Female patients aged ≥18 and ≤75 years at the time of signing the informed consent form;

Expected survival time ≥12 weeks;

Patients with histologically or cytologically confirmed, previously untreated, unresectable recurrent or metastatic HER2-positive breast cancer;

Disqualifiers

Received surgical treatment, radical radiotherapy, immunotherapy, etc. within 4 weeks or 5 half-lives prior to the first dose.

Previously received ADC drug therapy with camptothecin derivatives as toxins.

History of severe cardiovascular or cerebrovascular disease within six months before screening.

Concomitant pulmonary disease resulting in severely impaired lung function.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BL-M07D1

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Pertuzumab

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Trastuzumab

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • Docetaxel

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

596 Participants
are divided into 2 treatment groups
Group A: BL-M07D1 + PertuzumabExperimental treatment 2 interventions
Group B: Docetaxel + Trastuzumab + PertuzumabActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Progression-free survival (PFS)

Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.

Time frame
Up to approximately 24 months

Secondary outcomes

1

Overall survival (OS)

Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.

Time frame
Up to approximately 24 months
2

Objective Response Rate (ORR)

Objective response rate (ORR) is defined as the number of CR and PR in the treatment and control groups divided by the number of that group in the full analysis set (FAS).

Time frame
Up to approximately 24 months
3

Duration of Response (DOR)

Duration of Response (DOR) : defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death.

Time frame
Up to approximately 24 months
4

Disease Control Rate (DCR)

Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria.

Time frame
Up to approximately 24 months

Other outcomes

Sponsors and contacts

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

Sichuan Baili Pharmaceutical Co., Ltd.

Lead sponsor

Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov
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