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

NCT ID: NCT07130643

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-20
• Study Completion Date: 2027-06-20

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment

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

Group Type: EXPERIMENTAL

CDK4/6 inhibitors+Endocrine Therapy

Intervention Type: DRUG

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

Interventions

CDK4/6 inhibitors+Endocrine Therapy

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Age ≥18 years old.

2. 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).

3.Patients had to have histologically confirmed ER and (or PR>10%, HER2 -, early-stage invasive disease.

4.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.

5. ECOG PS score 0-2.

6. Patients must be able and willing to swallow and retain oral medications.

7. 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.

8.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.

9. Absolute neutrophil count ≥1500/µL, platelet ≥100000/mm3, hemoglobin ≥10g/dL

Exclusion Criteria

• 1. Prior treatment with any CDK4/6 inhibitor.

2. Inflammatory or stage IV or bilateral breast cancer.

3. 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.

5. Uncontrolled coexisting medical conditions may limit adherence to study requirements.

6. Pregnant women with a negative pregnancy test within 14 days before admission or women of childbearing potential.

7. Patients with a history of any malignancy were not eligible.

8. Patients receiving endocrine therapy within 5 years before diagnosis of current malignancy.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Xinhong Wu, PhD

OTHER

Sponsor Role: lead

Responsible Party

Xinhong Wu, PhD

PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

No. 119 Zhuodaoquan South Road

Wuhan, Hubei, China

Countries

China

Other Identifiers

OBU-BC-II-209

Identifier Type: -

Identifier Source: org_study_id