A Prospective and Multicenter Clinical Study to Identify the Molecular Characterization and Subtypes in Patients With HER2-positive Breast Cancer Receiving Neoadjuvant Trastuzumab and Pertuzumab.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,039
- 主要终点
- Total pathological complete response (tpCR) rate
研究概览
简要总结
This study will evaluate the safety and efficacy of neoadjuvant trastuzumab, pertuzumab and chemotherapy chosen by the investigators and identify the molecular characterization and subtypes in human epidermal growth factor receptor 2 (HER2)-positive breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years;
- •Eastern Cooperative Oncology Group (ECOG) score status 0-
- •Histologically confirmed invasive breast carcinoma with a primary tumor size of more than (>) 2 centimeters (cm) by standard local assessment technique; Breast cancer stage at presentation: early-stage (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0; T4, any N, M0);
- •HER2-positive breast cancer confirmed by immunohistochemistry or HER2 gene amplification by in situ hybridization;
- •Known estrogen receptor (ER) and progesterone receptor (PgR) status.
- •Has adequate bone marrow, renal, hepatic and blood clotting functions.
- •Left ventricular ejection fraction (LVEF) ≥50 percent (%).
- •Women of childbearing potential and men with partners of childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 7 months. Negative serum or urine pregnancy test within 7 days before study enrollment.
- •Willing to provide tissue for research purposes.
- •Volunteer to participate in this study and sign the informed consent.
排除标准
- •Patients with stage IV metastatic breast cancer.
- •Bilateral invasive breast cancer;
- •Patients with breast cancer who have previously received anti-tumor therapy.
- •Occurred or present with other malignant tumors within 5 years. Patients with the following two conditions can be enrolled: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)];
- •Subjects had participated in clinical trials of other antineoplastic drugs within 4 weeks before the group;
- •Has uncontrolled or significant cardiovascular disease.
- •Allergy to any investigational drug or any ingredient or excipient in the drug;
- •Female subjects who are pregnant, lactating or plan to become pregnant during the study.
- •Has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
研究组 & 干预措施
Trastuzumab+Pertuzumab+Chemotherapy
Participants will be administered at least 4-6 cycles of neoadjuvant pertuzumab plus trastuzumab -containing regimens chosen by the investigators prior to surgery.
干预措施: Chemotherapy (Drug)
Trastuzumab+Pertuzumab+Chemotherapy
Participants will be administered at least 4-6 cycles of neoadjuvant pertuzumab plus trastuzumab -containing regimens chosen by the investigators prior to surgery.
干预措施: Excision of tumor/mastectomy (Procedure)
Trastuzumab+Pertuzumab+Chemotherapy
Participants will be administered at least 4-6 cycles of neoadjuvant pertuzumab plus trastuzumab -containing regimens chosen by the investigators prior to surgery.
干预措施: Trastuzumab (Drug)
Trastuzumab+Pertuzumab+Chemotherapy
Participants will be administered at least 4-6 cycles of neoadjuvant pertuzumab plus trastuzumab -containing regimens chosen by the investigators prior to surgery.
干预措施: Pertuzumab (Drug)
结局指标
主要结局
Total pathological complete response (tpCR) rate
时间窗: At surgery
The pathological complete response rate described as the absence of invasive tumor cells in the breast and ipsilateral axillary lymph nodes upon microscopic examination following
次要结局
- Objective Response Rate (ORR)(Before surgery)
- Breast pathological complete response (bPCR) rate(At surgery)
- Number of participants with adverse events (AEs)(Assessed every 2 cycles of neoadjuvant therapy prior to surgery, up to approximately 30 days after the last neoadjuvant treatment.)
- Identification of HER2-Positive Breast Cancer Molecular Characterization and Subtypes.(Up to approximately 2 years from study enrollment)
研究者
Jinming Yu
PhD, MD
Shandong Cancer Hospital and Institute