Clinical trial · Interventional

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

NCT07446686CI-TRIAL-00104441not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
CDK4/6 inhibitor±endocrine therapy drug±OFS treatment combined with synchronous radiotherapy	Drug	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Radiotherapy with concurrent CDK4/6 inhibitors combined with endocrine therapy
description
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.
interventionNames
1. Drug: CDK4/6 inhibitor±endocrine therapy drug±OFS treatment combined with synchronous radiotherapy

Primary outcomes (1)

measure
tolerability and safety
timeFrame
From enrollment to 3 months after the end of radiotherapy
description
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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.