To hear about similar clinical trials, please enter your email below
Trial Title:
A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
NCT ID:
NCT06316531
Condition:
HER2-positive Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BL-M07D1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Experimental Group
Intervention type:
Drug
Intervention name:
T-DM1
Description:
Administration by intravenous infusion for a cycle of 3 weeks.
Arm group label:
Control group
Summary:
This study is a registered phase III, randomized, open-label, multicenter study to
evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally
advanced or metastatic HER2-positive breast cancer who had failed previous treatment with
taxanes and trastuzumab.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent and follow the requirements of the protocol;
2. No gender limit;
3. Age ≥18 years old and ≤75 years old at the time of signing the informed consent;
4. expected survival time ≥3 months;
5. Patients with histologically or cytologically confirmed, unresectable, locally
advanced or metastatic HER2-positive breast cancer;
6. Provide the latest tumor tissues to the central laboratory for HER2 and HR
detection;
7. Must have at least one measurable target lesion that meets the RECIST v1.1
definition;
8. ECOG 0 or 1;
9. Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by
NCI-CTCAE v5.0;
10. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
11. Blood transfusion is not allowed within 14 days before the first use of the study
drug, and no cell growth factor is allowed;
12. Coagulation function: international normalized ratio (INR) ≤1.5 and activated
partial thromboplastin time (APTT)≤1.5×ULN;
13. Urine protein ≤2+ or < 1000mg/24h;
14. For premenopausal women with childbearing potential, a pregnancy test must be
performed within 7 days before the initiation of treatment, serum pregnancy must be
negative, and must be non-lactating; All enrolled patients (male or female) were
advised to use adequate barrier contraception throughout the treatment cycle and for
7 months after the end of treatment.
Exclusion Criteria:
1. Received chemotherapy with mitomycin C and nitrosourea within 6 weeks before the
first dose, received surgery, chemotherapy, immunotherapy, etc. Within 4 weeks
before the first dose, received endocrine therapy, palliative radiotherapy, and
anti-tumor therapy approved by NMPA within 2 weeks before the first dose;
2. Previous use of HER2-ADC in the metastatic background;
3. Prior treatment with an ADC drug containing a camptothecin derivative (topoisomerase
I inhibitor) as a toxin;
4. The history of severe cardiovascular and cerebrovascular diseases in the past six
months was screened;
5. Complicated with pulmonary diseases leading to severe impairment of lung function;
6. History of ILD/interstitial pneumonia, current ILD/interstitial pneumonia, or
suspected ILD/interstitial pneumonia; According to CTCAE v5.0 was defined as ≥ grade
3 pulmonary disease and ≥ grade 2 radiation pneumonitis;
7. QT prolongation, complete left bundle branch block, III degree atrioventricular
block, frequent and uncontrollable arrhythmia;
8. Other primary malignancies diagnosed within 5 years before the first dose;
9. Poorly controlled hypertension (systolic blood pressure > 150 mmHg or diastolic
blood pressure > 100 mmHg);
10. Patients with active central nervous system metastases;
11. Patients with a history of allergy to recombinant humanized antibody or to any of
the excipents of BL-M07D1;
12. Patients with known hypersensitivity or delayed hypersensitivity to certain
components of T-DM1 or similar drugs, or known contraindications to T-DM1;
13. History of autologous or allogeneic stem cell transplantation or organ
transplantation;
14. Anthracycline-equivalent cumulative dose of adriamycin > 360 mg/m2;
15. Human immunodeficiency virus antibody positive, active hepatitis B virus infection,
cirrhosis, or hepatitis C virus infection;
16. Serious infection within 4 weeks before the first dose of study drug; There was
active pulmonary inflammation at the time of screening;
17. Patients with massive or symptomatic effusions or poorly controlled effusions;
18. Receiving active antiinflammatory drugs or any form of immunosuppressive therapy
before randomization;
19. A history of severe neurological or psychiatric illness;
20. Subjects with clinically significant bleeding or obvious bleeding tendency within 4
weeks before signing the informed consent;
21. Intestinal obstruction, Crohn's disease, ulcerative colitis or chronic diarrhea;
22. Subjects who are scheduled to receive live vaccine or receive live vaccine within 28
days before the first dose;
23. Patients who were deemed by the investigator to be ineligible for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Erwei Song
Investigator:
Last name:
Erwei Song
Email:
Principal Investigator
Investigator:
Last name:
Herui Yao
Email:
Principal Investigator
Start date:
May 8, 2024
Completion date:
May 2026
Lead sponsor:
Agency:
Sichuan Baili Pharmaceutical Co., Ltd.
Agency class:
Industry
Collaborator:
Agency:
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Sichuan Baili Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06316531
