HER2-positive Breast Cancer
Conditions
Brief 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).
Interventions
DRUGBL-M07D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGPertuzumab
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGdocetaxel
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGcarboplatin
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGtrastuzumab
Administration by intravenous infusion for a cycle of 3 weeks.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form and comply with protocol requirements; 2. Female aged ≥18 and ≤75 years at the time of signing the informed consent form; 3. Expected survival time ≥6 months; 4. Patients with HER2-positive invasive breast cancer confirmed by histological examination; 5. Clinical stage II-III confirmed based on the 8th edition of the American Joint Committee on Cancer (AJCC) staging system before neoadjuvant therapy; 6. Treatment-naive trial participants who have not received any anti-tumor therapy for breast cancer; 7. Trial participants agree to undergo mastectomy or breast-conserving surgery after completion of neoadjuvant therapy; 8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 9. Organ function levels must meet the requirements; 10. 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.
Exclusion criteria
1. History of breast cancer and tumor treatment; 2. Diagnosis of other primary malignancies within 5 years before the first dose; 3. History of severe cardiovascular or cerebrovascular disease within 6 months before screening; 4. Prolonged QTc interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; 5. Hypertension inadequately controlled with two antihypertensive medications; 6. Concurrent pulmonary disease resulting in severe impairment of pulmonary function; 7. History of interstitial lung disease/interstitial pneumonia requiring steroid therapy, etc.; 8. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; 9. Positive human immunodeficiency virus antibody, active hepatitis B virus infection, or hepatitis C virus infection; 10. Patients with poorly controlled blood glucose; 11. Severe infection within 4 weeks before the first use of the study drug; active pulmonary inflammation at screening; 12. 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; 13. Known hypersensitivity to the study treatment or any study drug excipients or other monoclonal antibodies; 14. Patients unsuitable for receiving the investigational drug; 15. History of autologous or allogeneic stem cell transplantation or organ transplantation; 16. Severe neurological or psychiatric disorders; 17. Subjects with clinically significant bleeding or a significant bleeding tendency within 4 weeks before signing informed consent; 18. Intestinal obstruction, Crohn's disease, ulcerative colitis, or chronic diarrhea, etc.; 19. Subjects planning to receive, or having received, live vaccines within 28 days before the first dose; 20. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) rate | Up to approximately 48 months | Pathological complete response (pCR) rate will be investigated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Event-free survival (EFS) | 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. |
| Invasive disease-free survival (IDFS) | 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. |
| Overall Survival (OS) | 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. |
| Treatment Emergent Adverse Event (TEAE) | 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. |
| Pathologic complete response (pCR) rate as assessed by the pathologists | Up to approximately 48 months | Pathologic complete response (pCR) rate as assessed by the pathologists at the participating study centers will be investigated. |
| Objective Response Rate (ORR) | 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). |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed