HER2-positive Breast CancerPhase 3NCT06830889
A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
A Phase 3 study testing BL-M07D1 and T-DM1 in people with HER2-positive Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy. 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 and T-DM1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,450 participants
- Where
- 2 sitesChina
- Study dates
- 3 Jun 2025to Dec 2031
- Phase
- Phase 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
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Women aged ≥18 years and ≤75 years at the time of written informed consent;
- Expected survival time ≥6 months;
- Patients with histologically confirmed HER2-positive invasive breast cancer;
- Before neoadjuvant therapy, the clinical TNM staging was T1-4, N0-3, M0 (excluding T1N0) based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system;
- The presence of residual invasive cancer confirmed by postoperative pathological examination must meet one of the conditions specified in the protocol;
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- Previous neoadjuvant therapy should meet the prescribed treatment conditions;
- Had received radical mastectomy;
- Determine hormone receptor (HR) status;
- The interval between radical surgery and randomization was at least 3 weeks and at most 12 weeks;
- ECOG score 0 or 1;
- The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
- No blood transfusion within 14 days before the first use of the study drug and no use of colony-stimulating factors were allowed;
- For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, serum pregnancy must be negative, and the patient must not be lactating; All enrolled patients should use adequate and highly effective contraception during the entire treatment cycle and for 7 months after the end of treatment.
Who cannot join
- A diagnosis of stage IV metastatic breast cancer was made;
- Bilateral breast cancer;
- Any previous history of breast cancer (unilateral or contralateral) except for lobular carcinoma in situ (LCIS);
- Evidence of clinically significant residual disease or recurrent or metastatic disease after neoadjuvant therapy and surgery;
- Other primary malignancies diagnosed within 5 years before the first dose;
- Received previous HER2-ADC, immunotherapy, or other antitumor biological therapy;
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- Subjects are participating in other clinical studies and receiving anti-tumor treatment;
- Prior treatment with anthracyclines, doxorubicin equivalent cumulative dose > 240 mg/m2; Cumulative dose of epirubicin or liposomal doxorubicin hydrochloride > 480 mg/m2;
- History of severe cardiovascular or cerebrovascular disease within six months before screening;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Poorly controlled hypertension (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
- Complicated with pulmonary diseases leading to severe impairment of lung function;
- A history of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia, or suspected such disease during screening; CTCAE v5.0 was used to define grade ≥3 pulmonary disease and grade ≥2 radiation pneumonitis;
- Human immunodeficiency virus antibody (HIVAb) positive, active hepatitis B virus infection, liver cirrhosis, or hepatitis C virus infection;
- Had a serious infection within 4 weeks before the first dose of study drug; There was active pulmonary inflammation at the time of screening;
- Were receiving \> within 2 weeks before the first dose; 10mg/d prednisone systemic corticosteroids or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy;
- Patients with a history of severe allergy to recombinant humanized antibodies or to any of the excipents of BL-M07D1;
- Known hypersensitivity or delayed hypersensitivity to certain components of T-DM1 or similar drugs, or known contraindications to T-DM1;
- Had a history of autologous or allogeneic stem cell transplantation or organ transplantation;
- Have a severe neurological or psychiatric illness;
- Subjects with clinically significant bleeding or obvious bleeding tendency within 4 weeks before signing the informed consent;
- Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;
- Subjects scheduled to receive live vaccine or within 28 days before the first dose;
- Patients with other serious physical and laboratory abnormalities or poor adherence that may increase the risk of participating in the study, or interfere with the results of the study, and patients who were deemed by the investigators to be unsuitable for participation in the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu
Yongmei Yin
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jiong Wu
About this study
Official title: A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- BL-M07D1, T-DM1
- Keywords
- HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy
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.
T-DM1Drug
Administration by intravenous infusion for a cycle of 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| BL-M07D1 | Experimental | Participants receive BL-M07D1 as intravenous infusion 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 |
| T-DM1 | Active comparator | Participants receive T-DM1 as intravenous infusion 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: T-DM1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-free Survival (IDFS)
IDFS refers to the absence of invasive cancer recurrence after breast cancer treatment.
Measured: Up to approximately 77 months
Secondary outcomes (4)
Disease-free Survival(DFS)
DFS is defined as the time from random occurrence of a tumor to recurrence.
Measured: Up to approximately 77 months
Distant Recurrence-free Interval (DRFI)
DRFI is defined as the interval from the date of randomization to the first occurrence of distant recurrence of breast cancer or death due to breast cancer.
Measured: Up to approximately 77 months
Overall Survival (OS)
Overall survival (OS) is defined as the time between the subject's randomization date and subject's death.
Measured: Up to approximately 77 months
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 77 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start3 Jun 2025
- Primary completionOct 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Sichuan Baili Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830889
- Sponsor's protocol ID
- BL-M07D1-302
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Phase Ill Clinical Study of BL-M07D1 for Injection Versus Trastuzumab Emtansine (T-DM1) in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06830889
- Acronym / sponsor ID
- BL-M07D1-302
- Conditions
- HER2-positive Breast Cancer
- Keywords
- HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,450 participants (estimated)
- Lead sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Oct 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is a registered phase III, randomized, open-label, multicenter study designed to evaluate the efficacy and safety of BL-M07D1 in the adjuvant treatment of HER2-positive breast cancer with residual invasive cancer after neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BL-M07D1 | Experimental | Drug: BL-M07D1Participants receive BL-M07D1 as intravenous infusion 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. |
| T-DM1 | Active comparator | Drug: T-DM1Participants receive T-DM1 as intravenous infusion 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Sign the informed consent form voluntarily and follow the protocol requirements;
- Women aged ≥18 years and ≤75 years at the time of written informed consent;
- Expected survival time ≥6 months;
- Patients with histologically confirmed HER2-positive invasive breast cancer;
- Before neoadjuvant therapy, the clinical TNM staging was T1-4, N0-3, M0 (excluding T1N0) based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system;
Key exclusion criteria (24 listed)
- A diagnosis of stage IV metastatic breast cancer was made;
- Bilateral breast cancer;
- Any previous history of breast cancer (unilateral or contralateral) except for lobular carcinoma in situ (LCIS);
- Evidence of clinically significant residual disease or recurrent or metastatic disease after neoadjuvant therapy and surgery;
- Other primary malignancies diagnosed within 5 years before the first dose;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BL-M07D1Administration by intravenous infusion for a cycle of 3 weeks. | Drug | BL-M07D1 |
| T-DM1Administration by intravenous infusion for a cycle of 3 weeks. | Drug | T-DM1 |
Primary outcome
Invasive Disease-free Survival (IDFS)
Time frame: Up to approximately 77 months
IDFS refers to the absence of invasive cancer recurrence after breast cancer treatment.
4 secondary outcomes
Disease-free Survival(DFS)
Time frame: Up to approximately 77 months
Distant Recurrence-free Interval (DRFI)
Time frame: Up to approximately 77 months
Overall Survival (OS)
Time frame: Up to approximately 77 months
Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 77 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BL-M07D1 and T-DM1 in people with HER2-positive Breast Cancer, run by Sichuan Baili Pharmaceutical Co., Ltd. at 2 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 14 inclusion and 24 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 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 phase mean?
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?
Invasive Disease-free Survival (IDFS) (time frame: Up to approximately 77 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2026.