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A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

ConditionHER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorSichuan Baili Pharmaceutical Co., Ltd.

About this trial

This trial is a registered phase III, randomized, open and multicenter study to evaluate the efficacy and safety of BL-M07D1 with or without Pertuzumab in the neoadjuvant treatment of HER2-positive breast cancer. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily signed informed consent and followed the program requirements;

Females ≥18 and ≤75 years of age at the time of signing the informed consent;

Expected survival time ≥6 months;

Patients with HER2-positive invasive breast cancer confirmed by histologic examination;

Disqualifiers

Diagnosis of stage IV metastatic breast cancer;

Bilateral breast cancer;

Prior history of any breast cancer (unilateral or contralateral) other than lobular carcinoma in situ (LCIS);

Diagnosis of another primary malignancy within 5 years prior to first dose;

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.

  • docetaxel

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • carboplatin

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • trastuzumab

    Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

Treatment groups

985 Participants
are divided into 2 treatment groups
Group A: Study treatmentExperimental treatment 2 interventions
Group B: docetaxel + carboplatin + trastuzumab + pertuzumabActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rate

Pathological complete response (pCR) rate will be investigated.

Time frame
Up to approximately 48 months

Secondary outcomes

1

Event-free survival (EFS)

Event-free survival (EFS) is defined as the time between the day the subject is randomized and the first occurrence of any event.

Time frame
Up to approximately 48 months
2

Invasive disease-free survival (IDFS)

Invasive disease-free survival (IDFS) is defined as the time interval from the date of radical surgery to the presence of ipsilateral or contralateral recurrence of invasive breast cancer, locoregional recurrence, distant recurrence, or death from any cause, whichever occurs first.

Time frame
Up to approximately 48 months
3

Overall Survival (OS)

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

Time frame
Up to approximately 48 months
4

Treatment Emergent Adverse Event (TEAE)

TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M07D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M07D1.

Time frame
Up to approximately 48 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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