A Phase III Randomized Controlled Clinical Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+/HER2- Breast Cancer After Failure of Prior Endocrine Therapy(PANKU-Breast03)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 446
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This trial is a registrational Phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-B01D1 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer after failure of prior endocrine therapy.
详细描述
In this trial, the experimental group receives BL-B01D1, and the control group receives chemotherapy of physician's choice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntarily sign the informed consent form and comply with the protocol requirements;
- •No gender restrictions;
- •Age ≥ 18 years;
- •Expected survival time ≥ 3 months;
- •Patients with unresectable locally advanced, recurrent, or metastatic HR+ HER2- breast cancer;
- •Trial participants have not received systemic chemotherapy;
- •Trial participants have progressed after at least one line of endocrine therapy, etc.;
- •Documented radiographic disease progression prior to enrollment;
- •Agree to provide archived tumor tissue specimens or fresh tissue samples from the primary or metastatic lesion within 3 years;
- •Must have at least one measurable lesion as defined by RECIST v1.1;
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
- •Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
- •No severe cardiac dysfunction, with left ventricular ejection fraction (LVEF) ≥ 50%;
- •Must meet required organ function levels;
- •Urinary protein ≤ 2+ or < 1000 mg/24h;
- •For premenopausal women of childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, with a negative serum pregnancy result, and they must not be breastfeeding; all enrolled patients (regardless of gender) must use adequate barrier contraception throughout the treatment period and for 6 months after treatment ends.
排除标准
- •Previously treated with ADC drugs that use topoisomerase I inhibitors as the toxin or target EGFR and/or HER3;
- •Use of chemotherapy, biotherapy, immunotherapy, etc., within 4 weeks or 5 half-lives before the first dose;
- •Previous treatment with anthracycline drugs where the equivalent cumulative dose of doxorubicin exceeds 360 mg/m²;
- •History of severe cardiovascular or cerebrovascular diseases;
- •Unstable thrombotic events requiring therapeutic intervention within 6 months before screening;
- •Prolonged QT interval, complete left bundle branch block, etc.;
- •Diagnosis of another malignancy within 3 years before the first dose;
- •Hypertension poorly controlled by two antihypertensive medications;
- •Poorly controlled blood glucose levels;
- •History of ILD requiring steroid therapy, current ILD, or grade ≥2 radiation pneumonitis, etc.;
- •Concurrent pulmonary diseases causing clinically severe respiratory function impairment;
- •Patients with active central nervous system metastases;
- •Presence of large serous cavity effusions or symptomatic serous cavity effusions, etc.;
- •Imaging findings indicating tumor invasion or encasement of the abdomen, chest, etc.;
- •Severe infection within 4 weeks before study randomization;
- •Severe, unhealed wounds, ulcers, or fractures within 4 weeks before signing the informed consent form;
- •Trial participants with clinically significant bleeding or a significant bleeding tendency within 4 weeks prior to signing the informed consent form;
- •History of inflammatory bowel disease, extensive bowel resection, etc.;
- •Patients with a history of allergy to recombinant humanized antibodies or allergy to BL-B01D1 or any of its excipients;
- •History of autologous or allogeneic stem cell transplantation;
- •Positive for human immunodeficiency virus antibodies, active hepatitis B virus infection, or hepatitis C virus infection;
- •Receipt of other unapproved clinical study drugs or treatments within 4 weeks before the first dose;
- •Trial participants planning to receive or having received live vaccines within 28 days before the first dose;
- •Other conditions deemed by the investigator to be unsuitable for participation in this clinical trial due to complications or other reasons.
研究组 & 干预措施
BL-B01D1
Participants receive BL-B01D1 in the first cycle (3 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: BL-B01D1 (Drug)
Albumin-bound paclitaxel, paclitaxel, or capecitabine
Participants receive Albumin-bound paclitaxel, paclitaxel, or capecitabine in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Albumin-Bound Paclitaxel (Drug)
Albumin-bound paclitaxel, paclitaxel, or capecitabine
Participants receive Albumin-bound paclitaxel, paclitaxel, or capecitabine in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Paclitaxel (Drug)
Albumin-bound paclitaxel, paclitaxel, or capecitabine
Participants receive Albumin-bound paclitaxel, paclitaxel, or capecitabine in the first cycle. Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Up to approximately 24 months
Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death.
次要结局
- Overall Survival (OS)(Up to approximately 24 months)
- Objective Response Rate (ORR)(Up to approximately 24 months)
- Disease Control Rate (DCR)(Up to approximately 24 months)
- Duration of Response (DOR)(Up to approximately 24 months)
- Treatment Emergent Adverse Event (TEAE)(Up to approximately 24 months)
- Anti-drug antibody (ADA)(Up to approximately 24 months)