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Compares treatment options for HER2-low Breast Cancer
Official title A Study of BL-M07D1 Versus Investigator's Choice of Chemotherapy in Patients With HER2-low Recurrent/Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06957886
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-low 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 and multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable, locally recurrent or metastatic HER2-low breast cancer.
- 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
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- Women aged ≥18 years and ≤75 years at the time of written informed consent;
- Expected survival time ≥12 weeks;
- Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;
- Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;
You likely can't join if
- Received mitomycin C and nitrosourea chemotherapy within 6 weeks before the first dose, and received surgery or radical radiotherapy within 4 weeks...
- Patients who were not suitable to use the control drugs chosen by the researchers because of intolerance to the chemotherapy drugs of the control...
- Previous treatment with anti-HER2 drugs;
- Prior ADC drug therapy with camptothecin derivative as toxin;
- The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- Severe impairment of lung function due to concurrent pulmonary diseases;
See the full eligibility criteria
- Voluntarily sign the informed consent and follow the requirements of the protocol;
- Women aged ≥18 years and ≤75 years at the time of written informed consent;
- Expected survival time ≥12 weeks;
- Histologically or cytologically confirmed unresectable, locally recurrent or metastatic HER2-low breast cancer;
- Provide the latest tumor tissues to the central laboratory for HER2 and HR detection;
- Meet the treatment requirements in the plan;
- Must have at least one measurable target lesion that meets the RECIST v1.1 definition;
- ECOG 0 or 1;
- Toxicity of previous antineoplastic therapy has returned to ≤ grade 1 defined by NCI-CTCAE v5.0;
- Organ function level must meet the requirements;
- 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...
- Received mitomycin C and nitrosourea chemotherapy within 6 weeks before the first dose, and received surgery or radical radiotherapy within 4 weeks before the first dose;
- Patients who were not suitable to use the control drugs chosen by the researchers because of intolerance to the chemotherapy drugs of the control group or other contraindications;
- Previous treatment with anti-HER2 drugs;
- Prior ADC drug therapy with camptothecin derivative as toxin;
- The history of severe cardiovascular and cerebrovascular diseases in the past six months was screened;
- Severe impairment of lung function due to concurrent pulmonary diseases;
- History of ILD/interstitial pneumonia requiring steroid therapy, current ILD/interstitial pneumonia or suspected ILD/interstitial pneumonia;
- QT prolongation, complete left bundle branch block, III degree atrioventricular block, frequent and uncontrollable arrhythmia;
- Other primary malignancies diagnosed within 5 years before the first dose;
- Poorly controlled hypertension;
- Patients with active central nervous system metastases;
- Patients with a history of severe allergy to any excipients or components of the study drug;
- History of autologous or allogeneic stem cell transplantation or organ transplantation;
- Anthracycline-equivalent cumulative dose of adriamycin \> 360 mg/m2;
- Human immunodeficiency virus antibody positive, active hepatitis B virus infection, cirrhosis, or hepatitis C virus infection;
- Serious infection within 4 weeks before the first dose of study drug; Severe infection requiring antibiotic, antiviral or antifungal control at screening;
- Patients with massive effusions, or effusions with obvious symptoms, or poorly controlled effusions;
- Carcinomatous lymphangitis;
- Was receiving \> before randomization; 10mg/d prednisone systemic corticosteroids or equivalent anti-inflammatory active drugs or any form of immunosuppressive therapy;
- The presence of a severe neurological or mental 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 who are scheduled to receive live vaccine or receive live vaccine within 28 days before the first dose;
- Patients with other serious physical or laboratory abnormalities or poor compliance that may increase the risk of participating in the study or interfere with the results of the study, and patients who are considered by...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Changsha, Hunan, 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 Guangzhou, Guangdong, China; Changsha, Hunan, 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.