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NCT06810492

The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment

Sponsor: Hongmei Zheng, PhD

View on ClinicalTrials.gov

Summary

To explore the efficacy and safety of CDK4/6 inhibitors combined with endocrine neoadjuvant therapy for stage II-III HR-positive/HER2-negative breast cancer. This study adopts a single-arm, open-label design, and plans to include 40 patients with stage II-III HR+/HER2- breast cancer.

Official title: A Single-arm Exploratory Study of the Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment of HR+/HER2- Early Breast Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-04-01

Completion Date

2027-12-01

Last Updated

2025-03-17

Healthy Volunteers

Conditions

Breast Cancer Stage III Breast Cancer Stage II

Interventions

DRUG

Ribociclib; abemaciclib; palbociclib; Dalpiciclib

Neoadjuvant therapy: CDK4/6 inhibitor combined with endocrine, a total of 6 cycles, 1 cycle every 28 days. CDK4/6 inhibitors (choose one of the following four types): * Dalpiciclib 125 mg orally once a day d1-21 every 28 days for a cycle (3 weeks/1 week off) * Palbociclib 125 mg orally once a day, d1-21, every 28 days in cycles (3 weeks/1 week off) * Abemaciclib 150 mg orally twice daily in 28-day cycles (may be reduced to 100 mg orally twice daily if not tolerated) * Ribociclib 400 mg orally once a day in a 28-day cycle Endocrine therapy drugs: take according to the label. Premenopausal patients need to be treated for ovarian function suppression.

Inclusion Criteria: 1. Age ≥ 18 years old. 2. Premenopausal and postmenopausal stage II-III females or males (patients with multicenter and/or multifocal early-invasive breast cancer) if all histopathological examination of tumors meet the pathological criteria of ER and/or PR\>10% and HER2- (HER2 expression 0 or 1+ or 2+ and negative FISH test). 3. Patients must have histologically confirmed ER and/or PR \>10%, HER2-, early invasive breast cancer. 4. Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, tumor evaluation PD/SD, advanced age, and inability to tolerate chemotherapy with underlying diseases. 5. ECOG PS score 0-2. 6. Patients must be able and willing to swallow and retain oral medications. 7. Premenopausal women within 14 days of enrollment, or women with amenorrhea for less than 12 months at the time of enrollment, must have a negative serum or urine pregnancy test. 8. Patients who have received neoadjuvant endocrine therapy are eligible for enrollment as long as they are enrolled within 6 months of initial histologic diagnosis and have completed no more than 2 months of neoadjuvant endocrine therapy. 9. Absolute neutrophil count ≥ 1500/µL, platelet ≥ 100000/mm3, hemoglobin ≥ 10g/dL Exclusion Criteria: 1. Prior treatment with any CDK inhibitor. 2. Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer. 3. History of anaphylaxis caused by chemical or biologic components similar to dalsily. 4. Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment. 5. Uncontrolled intercurrent illness that would limit compliance with study requirements. 6. Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission. 7. Patients with any history of malignancy are not eligible. 8. Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.