Breast cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
At the start date of the trial, patients who meet the eligibility criteria will begin to be enrolled in this study. General information and clinical diagnosis data of patients, including basic informa
Sponsors
First Hospital of China Medical University
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) is defined as the proportion of patients with a complete response (CR) or a partial response (PR) to treatment among the total number of patients enrolled, i.e., ORR = CR + PR / total number of patients ×100%. ORR will be evaluated at 4 to 6 months after initiating palbociclib treatment combined with endocrine therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pathologic complete response (pCR): pCR is defined as no residual in situ or invasive tumor in the breast or axillary nodes. pCR will be evaluated on the day of operation. 2. Disease-free survival (DFS): DFS is defined as the time from tumor resection to distant relapse or invasive contralateral breast cancer, which is used to determine patient survival. DFS will be evaluated from the time of surgery to tumor recurrence or metastasis. 3. Overall survival (OS): OS is defined as the time from randomization (starting point for survival analysis) to death. A small increase in improvement in OS is considered a clinically meaningful benefit. OS will be evaluated at the time from randomization to death. 4. Tumor resection rate: Tumor resection rate refers to the percentage of the number of patients who undergo cancer resection among the total number of patients. The cancer resection rate will be evaluated immediately after tumor resection. 5. Postoperative pathological evaluation using the Miller–Payne grading system and the Residual Cancer Burden index: 5.1. The Miller–Payne grading system is a five-grade classification method. It is used to grade the proportion of tumor cell reduction after treatment relative to that before treatment. Grade 1: no reduction in overall cellularity; grade 2: up to 30% reduction in cellularity; grade 3: 30%–90% reduction in cellularity; grade 4: marked disappearance of more than 90% of cellularity; grade 5: no invasive malignant cells identifiable in sections from the site of the tumor. 5.2. The Residual Cancer Burden index is an indicator used to judge the prognosis of four subtypes of breast cancer. It is also closely related to prognosis in patients subjected to long-term follow-up. The Residual Cancer Burden index will be evaluated immediately after tumor resection. 6. Incidence of adverse reactions = number of patients with | — |
Countries
China
Outcome results
None listed