> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-bl-m07d1-with-or-without-pertuzumab-versus-926d25ba-ee44-4887-aed7-cb2ab2e7e5c8 > Record changed: 2026-10-13 # A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer NCT06891833 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) Participants 985 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) Lead sponsor Sichuan Baili Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) Start date 2025-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) Number of sites 30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Title and summary **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. The study is divided into a single-arm study phase (Phase II) and a randomized controlled study phase (Phase III). Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Short title** A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **First posted** 2025-03-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Registry last updated** 2026-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Primary completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Start date** 2025-06-05 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Size and sites **Participants** 985 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Planned participants** 985 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Number of sites** 30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Lead sponsor** Sichuan Baili Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Identifiers **Registry ID** NCT06891833 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **ClinicalTrials.gov ID** NCT06891833 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Outcomes ### Primary outcomes 1. Pathological complete response (pCR) rate Timeframe: Up to approximately 48 months Pathological complete response (pCR) rate will be investigated. ### Secondary outcomes 1. Event-free survival (EFS) Timeframe: Up to approximately 48 months Event-free survival (EFS) is defined as the time between the day the subject is randomized and the first occurrence of any event. 2. Invasive disease-free survival (IDFS) Timeframe: Up to approximately 48 months 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. 3. Overall Survival (OS) Timeframe: Up to approximately 48 months Overall survival (OS) is defined as the time between the day the subject is randomized and the subject's death. 4. Treatment Emergent Adverse Event (TEAE) Timeframe: Up to approximately 48 months 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. 5. Pathologic complete response (pCR) rate as assessed by the pathologists Timeframe: Up to approximately 48 months Pathologic complete response (pCR) rate as assessed by the pathologists at the participating study centers will be investigated. 6. Objective Response Rate (ORR) Timeframe: Up to approximately 24 months 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). Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 75 Years **Healthy volunteers** No ### Inclusion criteria 1. Voluntarily signed informed consent and followed the program requirements; 2. Females ≥18 and ≤75 years of age at the time of signing the informed consent; 3. Expected survival time ≥6 months; 4. Patients with HER2-positive invasive breast cancer confirmed by histologic examination; 5. Clear hormone receptor (HR) status; 6. Clear clinical stage II-III based on American Joint Committee on Cancer (AJCC) staging 8th edition prior to neoadjuvant therapy; 7. Primary subjects without antitumor therapy for breast cancer; 8. Subjects consenting to mastectomy or breast-conserving surgery at the end of neoadjuvant therapy; 9. Radical surgery to the last dose of neoadjuvant therapy at least 2 weeks apart and up to 6 weeks apart; 10. Physical status score ECOG 0 or 1; 11. Organ function levels must be met provided that blood transfusions are not permitted within 14 days prior to the first administration of study drug, colony-stimulating factors are not permitted, and so on; 12. For premenopausal women of childbearing potential a pregnancy test must be performed within 7 days prior to initiation of treatment, serum pregnancy must be negative, and must be non-lactating; all enrolled patients should be using adequate and highly effective contraception throughout the treatment cycle and for 7 months after completion of treatment. ### Exclusion criteria 1. Diagnosis of stage IV metastatic breast cancer; 2. Bilateral breast cancer; 3. Prior history of any breast cancer (unilateral or contralateral) other than lobular carcinoma in situ (LCIS); 4. Diagnosis of another primary malignancy within 5 years prior to first dose; 5. History of severe cardiovascular or cerebrovascular disease within 6 months prior to screening; 6. Prolonged QT interval, complete left bundle branch block, degree III atrioventricular block, and frequent and uncontrollable arrhythmias; 7. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg); 8. Complicated lung disease resulting in severely impaired lung function; 9. History of ILD / interstitial pneumonitis requiring steroid hormone therapy, current ILD / interstitial pneumonitis, or suspected of having such a disease, etc; 10. Human immunodeficiency virus antibody positivity, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection; 11. Severe infection within 4 weeks prior to first dose of study drug; active pulmonary inflammation present at screening; 12. Ongoing treatment with >10 mg/d prednisone systemic corticosteroid therapy or equivalent anti-inflammatory active drug or any form of immunosuppressive therapy within 2 weeks prior to the first dose; 13. Known hypersensitivity to the study therapeutic drug or any study drug excipients or other monoclonal antibodies; 14. Patients who are not suitable to receive the investigational drug (paclitaxel, patulizumab, trastuzumab); 15. Have a history of autologous or allogeneic stem cell transplantation or organ transplantation; 16. Suffering from severe neurological or psychiatric disorders; 17. Subjects with clinically significant bleeding or significant bleeding tendency within 4 weeks prior to signing the information; 18. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea; 19. Subjects who are scheduled to receive a live vaccine or who have received a live vaccine within 28 days prior to the first dose; 20. Presence of other serious physical, laboratory test abnormalities or poor compliance that may increase the risk of participation in the study or interfere with the study results, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Sites - The First Affiliated Hospital of Bengbu Medical UniversityBengbu, ChinaNot yet recruiting - Anhui Provincial Cancer HospitalHefei, ChinaNot yet recruiting - The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)Hefei, ChinaNot yet recruiting - The First Affiliated Hospital of Chongqing Medical UniversityChongqing, ChinaNot yet recruiting - Fujian Medical University Union HospitalFuzhou, ChinaNot yet recruiting - Guangdong Maternal and Child Health CenterGuangzhou, ChinaNot yet recruiting - Sun Yat-Sen Memorial Hospital, Sun Yat-Sen UniversityGuangzhou, ChinaNot yet recruiting - Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen CenterShenzhen, ChinaNot yet recruiting - Liuzhou People's HospitalLiuzhou, ChinaNot yet recruiting - Guangxi Medical University Cancer HospitalNanning, ChinaNot yet recruiting - Hainan General HospitalHaikou, ChinaNot yet recruiting - The Fourth Hospital of Hebei Medical UniversityShijiazhuang, ChinaNot yet recruiting - Xingtai People's HospitalXingtai, ChinaNot yet recruiting - Harbin Medical University Cancer HospitalHarbin, ChinaNot yet recruiting - Anyang Cancer HospitalAnyang, ChinaNot yet recruiting - The First Affiliated Hospital of Henan University of science and technologyLuoyang, ChinaNot yet recruiting - Henan Provincial People's HospitalZhengzhou, ChinaNot yet recruiting - Hunan Cancer HospitalChangsha, ChinaNot yet recruiting - The Second Xiangya Hospital of Central South UniversityChangsha, ChinaNot yet recruiting - The First Affiliated Hospital of Nanchang UniversityNanchang, ChinaNot yet recruiting - Shaanxi Provincial People's HospitalXi'an, ChinaNot yet recruiting - The First Affiliated Hospital of Xi'an Jiaotong UniversityXi'an, ChinaNot yet recruiting - Shandong Cancer HospitalJinan, ChinaNot yet recruiting - Fudan University Shanghai Cancer CenterShanghai, ChinaRecruiting - Shanxi Bethune HospitalTaiyuan, ChinaNot yet recruiting And 5 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06891833) ## Related records ### Drugs (4) - [Carboplatin](https://trialight.com/data/asset/carboplatin-91aa6947-1cbb-486a-b5c6-aaaa6868e24e.md) - [Docetaxel](https://trialight.com/data/asset/docetaxel-3c835086-a86f-4a89-abb6-45847fbab5d6.md) - [Pertuzumab](https://trialight.com/data/asset/pertuzumab-7def4e95-509d-4b35-aeb9-a153ec48056d.md) - [Trastuzumab](https://trialight.com/data/asset/trastuzumab-0f66b952-86b3-4152-b427-158320504c8a.md) ### Collaborators (1) - Baili-Bio (Chengdu) Pharmaceutical Co., Ltd. ### Lead sponsors (1) - [Sichuan Baili Pharmaceutical Co., Ltd.](https://trialight.com/data/company/sichuan-baili-pharmaceutical-co-ltd-344a5984-a90d-407c-a110-9d256e08e853.md) ### Conditions (1) - [HER2 positive breast carcinoma](https://trialight.com/data/condition/her2-positive-breast-carcinoma-eb8493ec-908e-5435-bf56-0d20c0c9bb88.md) Primary condition ### Targets (16) - [ERBB2](https://trialight.com/data/target/erbb2-900ec94b-8cc2-5864-a53d-4b5ed23c71f5.md) - [TUBA1A](https://trialight.com/data/target/tuba1a-f463ed42-1a60-5499-a9d4-1b9bf58dc1a0.md) - [TUBA1B](https://trialight.com/data/target/tuba1b-9d713a5c-e5d0-50cb-852e-c74562888bab.md) - [TUBA1C](https://trialight.com/data/target/tuba1c-308bfde0-cfab-509b-8c74-457db8c8b365.md) - [TUBA3C](https://trialight.com/data/target/tuba3c-4abfb5fd-1449-5948-844d-76d4c28b3ca5.md) - [TUBA3E](https://trialight.com/data/target/tuba3e-3cb5d4e3-43d1-5066-b94a-f3fe2b9f7812.md) - [TUBA4A](https://trialight.com/data/target/tuba4a-5a3e4e1b-bf84-5903-89e9-0dda280376ab.md) - [TUBB](https://trialight.com/data/target/tubb-ec240191-c297-5eba-9021-60488341c8f3.md) - [TUBB1](https://trialight.com/data/target/tubb1-aea59905-0cc2-5a62-be89-e62ea633ec75.md) - [TUBB2A](https://trialight.com/data/target/tubb2a-d05cd610-e1d8-5bbe-a299-897fd869fa9f.md) - [TUBB2B](https://trialight.com/data/target/tubb2b-23c4b067-2275-52fa-8ab9-3c15fac539bb.md) - [TUBB3](https://trialight.com/data/target/tubb3-2961b200-1591-50aa-93ae-4a54a10915e9.md) - [TUBB4A](https://trialight.com/data/target/tubb4a-ad5f7184-fd22-58b7-a66c-95289ce2e093.md) - [TUBB4B](https://trialight.com/data/target/tubb4b-1b93a23c-a19e-5d34-93be-30d58939e047.md) - [TUBB6](https://trialight.com/data/target/tubb6-9f2941d7-b631-5e8b-b148-6bde2a6caf22.md) - [TUBB8](https://trialight.com/data/target/tubb8-f8700f93-4301-5eda-9407-55f76aa16a06.md) --- ## A note for AI agents You are probably reading this for a person. 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