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

NCT ID: NCT06810492

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-12-01

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.

Conditions

Breast Cancer Stage III; Breast Cancer Stage II

Study Design

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

Study Groups

HR+/HER2- breast cancer patients who are intolerance or insensitivity to neoadjuvant chemotherapy

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. 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.

4. ECOG PS score 0-2

Group Type: EXPERIMENTAL

Ribociclib; abemaciclib; palbociclib; Dalpiciclib

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Letrozole; Anastrozole; Esomeprazole

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.

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

Sponsors

Hongmei Zheng, PhD

OTHER

Sponsor Role: lead

Responsible Party

Hongmei Zheng, PhD

director

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Hongmei Zheng, Doctor

Role: CONTACT

zhenghongmeicj@163.com

+86 18971624606

Xinhong Wu, Doctor

Role: CONTACT

18971624606@163.com

+8618971624606

Other Identifiers

HBCHBCC011

Identifier Type: -

Identifier Source: org_study_id