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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiotherapy with concurrent CDK4/6 inhibitors combined with endocrine therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDK4/6 inhibitor±endocrine therapy drug±OFS treatment combined with synchronous radiotherapy | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 3 months after the end of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Age is 18-75 years old, gender is female
Postoperative pathological examination confirmed HR+, HER2- invasive breast cancer:
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%.
inspections, study treatment plans, laboratory tests, and other research procedures.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Li | Contact | 86-13628566285 | liyong7229771@163.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 30, 2025 |
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|
| Start of radiotherapy to 3 months after radiotherapy |
| Nov 10, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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