Clinical trial NCT06810492: The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Stage III
Breast Cancer Stage II
Keywords: Hormone receptor (HR) positive
HER2 negative
neoadjuvant treatment
CDK4/6 inhibitors
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate (ORR)
timeFrame: At the end of Cycle 6 (each cycle is 28 days)
Secondary outcomes:
measure: Ki67 variations
timeFrame: At the end of Cycle 2(each cycle is 28 days)
measure: complete cell cycle arrest (CCCA; Ki67 ≤ 2.7%)
timeFrame: 6 months
measure: iDFS
timeFrame: 2 years
measure: QoL
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: