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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorGuizhou Provincial People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

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;

Disqualifiers

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).

Trial design

Treatments tested in this trial

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

Treatment groups

30 Participants
are divided into 1 treatment group

Locations

This trial has no locations