Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

NOT YET RECRUITING

NCT07446686

EARLY_PHASE1

Study on the Safety and Tolerability of Postoperative Radiotherapy Concurrent With CDK4/6 Inhibitors in HR+/HER2- High-Risk Breast Cancer

Sponsor: Guizhou Provincial People's Hospital

View on ClinicalTrials.gov

Summary

The investigators combined postoperative radiotherapy with CDK4/6 inhibitors ± endocrine adjuvant therapy to explore the tolerability and safety of this treatment regimen in HR+/HER2- postoperative high-risk breast cancer patients. During the study, investigators also utilized PRO scales (FACT-B, FACT-ES, FACT-F) to evaluate patients' multidimensional experiences, such as physical function, emotional state, and treatment-related symptoms, thereby obtaining more authentic and reliable data for symptom assessment and patient benefit.

Key Details

Gender

FEMALE

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-01

Completion Date

2027-06-30

Last Updated

2026-03-03

Healthy Volunteers

Conditions

Breast Cancer

Interventions

DRUG

CDK4/6 inhibitor±endocrine therapy drug±OFS treatment combined with synchronous radiotherapy

After the patient is confirmed to be enrolled, the CDK4/6i dose for the next patient is determined by a dose allocation model (empirical logistic model, obtained using the R dfcrm software package) based on the DLT observed in all previously evaluated patients. The starting dose of CDK4/6i (abexiclib, oral) is 50 mg bid, and other dose levels are: 100 mg bid, 150 mg bid.

Inclusion Criteria: * Age is 18-75 years old, gender is female * Postoperative pathological examination confirmed HR+, HER2- invasive breast cancer: 1. ER positivity and/or PR positivity is defined as: all positively stained tumor cells The proportion of tumor cells is ≥10%; 2. HER2 negativity is defined as: 0/1+ by standard immunohistochemistry (IHC) test; ISH test was negative. * The time from radical surgery or breast-conserving surgery to randomization shall not exceed 6 months; * Postoperative pathological examination after radical surgery revealed the presence of lymph nodes in the axilla on the ipsilateral side of the breast lesion. Metastasis (lymph node micrometastases, ipsilateral internal mammary lymph nodes and supraclavicular lymph nodes are allowed) metastasis, but the number of metastases to the ipsilateral internal mammary lymph nodes and supraclavicular lymph nodes is not included in the positive calculation of sexual lymph nodes), the specific requirements are as follows: 1\) The number of lymph node metastases is ≥ 4; 2) When the number of lymph node metastases is 1 to 3, at least one of the following high-risk factors must be met: i. Postoperative pathological examination shows that the diameter of the primary tumor is ≥5cm; ii. The histological grade of the primary tumor is grade III (excluding grade II-III); iii. There is residual invasive cancer in breast lesions after neoadjuvant treatment; iv. Ki-67≥30%. * Eastern Cooperative Oncology Group (ECOG) physical status score is 0 -2 points. * With my consent and having signed the informed consent form, I am willing and able to comply with the planned interview. inspections, study treatment plans, laboratory tests, and other research procedures. Exclusion Criteria: * Pathological examination diagnosed as HER2-positive breast cancer (HER2-positive definition: standard immune Histochemistry (IHC) test is 3+ or ISH test is positive). * Local or regional recurrence of breast malignant tumors. * The clinical stage of the tumor is stage IV (metastatic) breast cancer. * Bilateral breast cancer (including contralateral carcinoma in situ). * History of serious lung diseases such as interstitial pneumonia. * Have received CDK4/6 inhibitor treatment or other anti-tumor biological treatments in the past therapy, targeted therapy or tumor immunotherapy. * Have undergone major surgical operations, any investigational drugs, or others within 4 weeks before randomization Anticancer treatment or use of immunomodulators (excluding surgery, chemotherapy, radiotherapy and endocrine therapy). * The presence of other serious physical or mental illnesses or laboratory abnormalities that may increase participation The risks of the research, or interference with the research results, and the researcher's opinion that he is not suitable to participate in this research study patients.