Palbociclib combined with aromatase inhibitors for the treatment of locally advanced HR+HER2- breast cancer insensitive to neoadjuvant chemotherapy: a prospective, single-arm, Phase II clinical trial

First Hospital of China Medical University0 个研究点目标入组 36 人开始时间: 2023年2月11日最近更新: 2023年2月20日

适应症

试验速览

阶段: 2 期
状态: 进行中（未招募）
发起方
入组人数: 36

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

性别: Female

入选标准

•1. Age >18 years (note: there is no upper age limit for the onset of breast cancer, and older patients are more intolerant of chemotherapy)
•2. Postmenopausal female patients; or premenopausal female patients who meet the menopausal standard after ovarian function suppression (OFS)*
•3. Before neoadjuvant chemotherapy, a needle biopsy of the breast will be performed to confirm the diagnosis of invasive breast cancer. In addition, immunohistochemistry will indicate ER-positive (ER expression = 50%), progesterone receptor (PR)-positive or negative, and HER2-negative luminal type breast cancer
•4. Patients who have not received any breast cancer-related treatment prior to admission
•5. Patients with newly confirmed breast cancer who have received two cycles of neoadjuvant chemotherapy (the neoadjuvant chemotherapy protocol will be determined according to patient condition) and are insensitive to neoadjuvant chemotherapy
•6. Availability of complete clinical pathological data
•* Menopausal women will be considered if one or more of the following conditions are met:
•1. Women who have undergone bilateral oophorectomy
•2. Age =60 years
•3. Age <60 years: For patients who have natural menopause =12 months, levels of follicle-stimulating hormone and estradiol within the postmenopausal range without receiving chemotherapy, tamoxifen, toremifene, or ovarian castration; for patients who are taking tamoxifen or toremifene, levels of follicle-stimulating hormone and estradiol levels should reach those of postmenopausal levels.
•Chemotherapy insensitivity: according to the efficacy evaluation criteria for solid tumors, chemotherapy insensitivity is considered when progressive disease (PD) or stable disease (SD) is established after two cycles of neoadjuvant chemotherapy.

排除标准

•1. Patients who have received surgery, radiotherapy and endocrine therapy related to breast cancer in the past
•2. Bilateral breast cancer: bilateral primary breast cancer and bilateral metastatic breast cancer. Generally, bilateral breast cancer refers to bilateral primary breast cancer; or inflammatory breast cancer: The first symptoms of primary inflammatory breast cancer are breast enlargement, skin redness and firmness, and pain. The typical clinical manifestations of primary inflammatory breast cancer are diffuse breast enlargement, skin congestion, and edema (orange peel skin) in 1/3 or more areas of the breast, and obvious palpable boundaries in the areas of congestion and edema. The boundaries of tumors are often unclear by palpation. The clinical manifestations are also accompanied by erysipelas such as edge or stripe pigmentation, an increase in skin temperature and tenderness. Some patients have skin ulcers caused by local tumor collapse, which is often secondary to locally advanced breast cancer.
•3. Patients complicated by other malignant tumors or having a history of other malignant tumors
•4. Patients with distant metastasis at initial diagnosis
•5. Patients with breast cancer, which will not be histopathologically confirmed
•6. Patients who have immune system disease, blood system disease, or mental disease before chemotherapy
•7. Before chemotherapy, patients have severe dysfunction of important organs such as the heart, liver, or kidney

研究者

发起方

First Hospital of China Medical University

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