Efficacy and Safety of CDK4/6 Inhibitors Combined With Endocrine Therapy in HR+/HER2- Neoadjuvant Therapy for Early Breast Cancer

NCT07130643 | Active Not Recruiting Phase 2

• 1 other identifier: OBU-BC-II-209
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single arm, open label, phase 2 trial aimed to investigate the effects and safety of neoadjuvant CDK4/6 inhibitors in combination with endocrine for HR+/HER2- breast cancer. A total of 40 patients with stage II-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated.Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists.

Conditions

HR+/HER2- Breast Cancer

Keywords

neoadjuvant; HR+/HER2- breast cancer; CDK4/6 inhibitors

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  ORR is defined as proportion of patients demonstrating either a partial response (PR) or a complete response (CR)

  up to 24 weeks

Secondary Outcomes (3)

• change in Ki67

  up to 24 weeks

• complete cell cycle arrest

  up to 4 weeks

• Invasive disease free survival（iDFS）

  up to 3 years

Study Arms (1)

treatment

EXPERIMENTAL

CDK4/6 inhibitors+Endocrine Therapy every 28 days for 6 cycles

Drug: CDK4/6 inhibitors+Endocrine Therapy

Interventions

CDK4/6 inhibitors+Endocrine Therapy DRUG

CDK4/6 inhibitors：dalpiciclib,palbociclib,abemaciclib,ribociclib

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≥18 years old.
• \. Premenopausal and postmenopausal women or men with stage II-III disease (multifocal and/or multifocal early invasive breast cancer) if all tumors on histopathological examination meet the pathological criteria for ER and/or PR \> 10% and HER2- (HER2 expression of 0 or 1+ or 2+ and negative FISH test).
• Patients had to have histologically confirmed ER and (or PR\>10%, HER2 -, early-stage invasive disease.
• Intolerance or insensitivity to neoadjuvant chemotherapy: 2 cycles of neoadjuvant chemotherapy, PD/SD according to tumor evaluation, old age, and basic diseases can not tolerate chemotherapy.
• \. ECOG PS score 0-2.
• \. Patients must be able and willing to swallow and retain oral medications.
• \. In premenopausal women, a serum or urine pregnancy test had to be negative within 14 days of enrollment or in women who had been amenorrhea for less than 12 months at enrollment.
• Patients who had received neoadjuvant endocrine therapy were eligible if they were enrolled within 6 months of the initial histologic diagnosis and had completed no more than 2 months of neoadjuvant endocrine therapy.
• \. Absolute neutrophil count ≥1500/µL, platelet ≥100000/mm3, hemoglobin ≥10g/dL

You may not qualify if:

• \. Prior treatment with any CDK4/6 inhibitor.
• \. Inflammatory or stage IV or bilateral breast cancer.
• \. History of allergic reactions caused by chemical or biological components similar to CDK4/6 inhibitors.
• Patients who received any drugs or substances that were effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
• \. Uncontrolled coexisting medical conditions may limit adherence to study requirements.
• \. Pregnant women with a negative pregnancy test within 14 days before admission or women of childbearing potential.
• \. Patients with a history of any malignancy were not eligible.
• \. Patients receiving endocrine therapy within 5 years before diagnosis of current malignancy.

Sponsors & Collaborators

• Xinhong Wu, PhD: lead

Study Sites (1)

No. 119 Zhuodaoquan South Road

Wuhan, Hubei, China

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): June 20, 2027
• Last Updated: August 19, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)