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.
Age is 18-75 years old, gender is female
ER positivity and/or PR positivity is defined as: all positively stained tumor cells The proportion of tumor cells is ≥10%;
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;
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).
Single group
CDK4/6 inhibitor±endocrine therapy drug±OFS treatment combined with synchronous radiotherapy
DrugAfter 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.
tolerability and safety
This study aims to investigate the tolerability and safety of postoperative adjuvant radiotherapy combined with CDK4/6 inhibitors in the treatment of hormone receptor-positive, HER2-negative high-risk breast cancer patients. Safety will be expressed by the incidence (%) of grade 3 and above adverse events during the course of treatment. Tolerability is expressed by the maximum dose (mg) of CDK4/6 inhibitor that the patient can use during the combination therapy.
To assess the impact of this combination regimen on patient quality of life
The quality of life of patients was assessed using the FACT-B, FACT-ES, and FACIT-F scales at (the day before radiotherapy (T0), week 4 (T1), after radiotherapy (T2), 1 month after radiotherapy (T3), and 3 months after radiotherapy (T4)), respectively. The score and total score at each time point are calculated separately through three scales: FACT-B: total score ranges from 0 to 144 points. FACT-ES: Total score ranges from 0-180. FACIT-F: Total score ranges from 0-52 points. In the FACT-B, a higher total score represents a better quality of life. In the FACIT-F and FACT-ES, the higher the total score, the less fatigue and endocrine symptoms are.
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