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Compares treatment options for HER2-positive Breast Cancer
Official title A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy
ClinicalTrials.gov ID: NCT06830889
What this study is testing
What is BL-M07D1?
BL-M07D1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2-positive breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- 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...
You likely can't join if
- 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;
See the full eligibility criteria
- 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;
- 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...
- 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;
- people 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...
- 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;
- people 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;
- people 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 study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.