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HER2-positive Breast CancerPhase 2/3NCT06891833

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

A Phase 2/3 study testing BL-M07D1, Pertuzumab and docetaxel in people with HER2-positive Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 30 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HER2-positive Breast Cancer
What is being tested?
BL-M07D1, Pertuzumab and docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
985 participants
Where
30 sitesChina
Study dates
5 Jun 2025to Dec 2028
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form and comply with protocol requirements;
  • Female aged ≥18 and ≤75 years at the time of signing the informed consent form;
  • Expected survival time ≥6 months;
  • Patients with HER2-positive invasive breast cancer confirmed by histological examination;
  • Clinical stage II-III confirmed based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system before neoadjuvant therapy;
  • Treatment-naive trial participants who have not received any anti-tumor therapy for breast cancer;
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  • Trial participants agree to undergo mastectomy or breast-conserving surgery after completion of neoadjuvant therapy;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
  • Organ function levels must meet the requirements;
  • For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment; serum pregnancy must be negative, and the patient must be non-lactating; all enrolled patients should adopt adequate highly effective contraceptive measures throughout the entire treatment cycle and for 7 months after treatment completion.

Who cannot join

  • History of breast cancer and tumor treatment;
  • Diagnosis of other primary malignancies within 5 years before the first dose;
  • History of severe cardiovascular or cerebrovascular disease within 6 months before screening;
  • Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
  • Hypertension inadequately controlled with two antihypertensive medications;
  • Concurrent pulmonary disease resulting in severe impairment of pulmonary function;
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  • History of interstitial lung disease/interstitial pneumonia requiring steroid therapy, etc.;
  • Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
  • Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection;
  • Patients with poorly controlled blood glucose;
  • Severe infection within 4 weeks before the first use of the study drug; active pulmonary inflammation at screening;
  • Receiving systemic corticosteroid therapy at >10 mg/day prednisone or equivalent anti-inflammatory activity, or any form of immunosuppressive therapy, within 2 weeks before the first dose;
  • Known hypersensitivity to the study treatment or any study drug excipients or other monoclonal antibodies;
  • Patients unsuitable for receiving the investigational drug;
  • History of autologous or allogeneic stem cell transplantation or organ transplantation;
  • Severe neurological or psychiatric disorders;
  • Subjects with clinically significant bleeding or a significant bleeding tendency within 4 weeks before signing informed consent;
  • Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.;
  • Subjects planning to receive, or having received, live vaccines within 28 days before the first dose;
  • Presence of other severe physical or laboratory abnormalities or poor compliance, etc., which may increase the risk of participating in the study or interfere with study results, or patients deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

30 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Sa Xiao, PHD contact

15013238943

xiaosa@baili-pharm.com

30 sites in 1 country

China30 sites, 30 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan

    Ya Wei

    Not yet recruiting

  • The First Affiliated Hospital of Bengbu Medical University

    Bengbu, Anhui

    Xin Jin

    Not yet recruiting

  • Hunan Cancer Hospital

    Changsha, Hunan

    Xiaobo Hu

    Not yet recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

    Wenjun Yi

    Not yet recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan

    Junjie Li

    Not yet recruiting

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Qiao Cheng

    Not yet recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

    Chuan Wang

    Not yet recruiting

  • Guangdong Maternal and Child Health Center

    Guangzhou, Guangdong

    Antai Zhang

    Not yet recruiting

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong

    Qiang Liu

    Not yet recruiting

  • Hainan General Hospital

    Haikou, Hainan

    Ru Chen

    Not yet recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Peifen Fu

    Not yet recruiting

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

    Yang Yu

    Not yet recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Tong Liu

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui

    Yueyin Pan

    Not yet recruiting

  • The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

    Hefei, Anhui

    Xiaopeng Ma

    Not yet recruiting

  • Shandong Cancer Hospital

    Jinan, Shandong

    Yongsheng Wang

    Not yet recruiting

  • Liuzhou People's Hospital

    Liuzhou, Guangxi

    Junyang Mo

    Not yet recruiting

  • The First Affiliated Hospital of Henan University of science and technology

    Luoyang, Henan

    Xinshuai Wang

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

    Yingliang Li

    Not yet recruiting

  • Guangxi Medical University Cancer Hospital

    Nanning, Guangxi

    Huawei Yang

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

    Zhimin Shao

    Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

    Shenzhen, Guangdong

    Jidong Gao

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Yunjiang Liu

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi

    Xiaojun Zhang

    Not yet recruiting

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi

    Guohui Han

    Not yet recruiting

  • Tianjin Cancer Hospital

    Tianjin, Tianjin Municipality

    Jin Zhang

    Not yet recruiting

  • Shaanxi Provincial People's Hospital

    Xi'an, Shaanxi

    Jianhui Li

    Not yet recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

    Yu Ren

    Not yet recruiting

  • Xingtai People's Hospital

    Xingtai, Hebei

    Xiangshun Kong

    Not yet recruiting

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

    Hui Liu

    Not yet recruiting

Other trials in China

About this study

Official title: A Randomized Controlled Phase II/III Clinical Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer

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).

Being tested
BL-M07D1, Pertuzumab, docetaxel, carboplatin, trastuzumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BL-M07D1Drug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • PertuzumabDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • docetaxelDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • carboplatinDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

  • trastuzumabDrug

    Administration by intravenous infusion for a cycle of 3 weeks.

Study groups in NCT06891833
Study groupRoleWhat they receive
Study treatmentExperimentalParticipants receive BL-M07D1 with or without Pertuzumab for the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: BL-M07D1; Drug: Pertuzumab
docetaxel + carboplatin + trastuzumab + pertuzumabActive comparatorParticipants receive docetaxel + carboplatin + trastuzumab + pertuzumaby in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
Receives: Drug: Pertuzumab; Drug: docetaxel; Drug: carboplatin; Drug: trastuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR) rate

    Pathological complete response (pCR) rate will be investigated.

    Measured: Up to approximately 48 months

Secondary outcomes (6)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to approximately 48 months

  5. Pathologic complete response (pCR) rate as assessed by the pathologists

    Pathologic complete response (pCR) rate as assessed by the pathologists at the participating study centers will be investigated.

    Measured: Up to approximately 48 months

  6. 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).

    Measured: Up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2025
  2. Study start5 Jun 2025
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
985 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06891833
Sponsor's protocol ID
BL-M07D1-303
Status last verified
Oct 2026
First submitted
18 Mar 2025
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing BL-M07D1, Pertuzumab and docetaxel in people with HER2-positive Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 30 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sa Xiao, PHD (15013238943, xiaosa@baili-pharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate (time frame: Up to approximately 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06891833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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