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

NCT06810492 | Not Yet Recruiting

• 1 other identifier: HBCHBCC011
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hormone receptor (HR) positive; HER2 negative; neoadjuvant treatment; CDK4/6 inhibitors

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  The main effect evaluation index was Objective response rate (ORR) after CDK4/6 inhibitor combined with endocrine, a total of 6 cycles.

  At the end of Cycle 6 (each cycle is 28 days)

Secondary Outcomes (4)

• Ki67 variations

  At the end of Cycle 2(each cycle is 28 days)

• complete cell cycle arrest (CCCA; Ki67 ≤ 2.7%)

  6 months

• iDFS

  2 years

• QoL

  1 year

Study Arms (1)

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

EXPERIMENTAL

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

Drug: Ribociclib; abemaciclib; palbociclib; Dalpiciclib

Interventions

Ribociclib; abemaciclib; palbociclib; Dalpiciclib 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.

Also known as: Letrozole, Anastrozole, Esomeprazole

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

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years old.
• 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).
• Patients must have histologically confirmed ER and/or PR \>10%, HER2-, early invasive breast cancer.
• 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.
• ECOG PS score 0-2.
• Patients must be able and willing to swallow and retain oral medications.
• 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.
• 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.
• Absolute neutrophil count ≥ 1500/µL, platelet ≥ 100000/mm3, hemoglobin ≥ 10g/dL

You may not qualify if:

• Prior treatment with any CDK inhibitor.
• Inflammatory breast cancer or stage IV breast cancer or bilateral breast cancer.
• History of anaphylaxis caused by chemical or biologic components similar to dalsily.
• Patients who have received any drugs or substances with effective CYP3A isoenzyme inhibitors or inducers within 7 days of enrollment.
• Uncontrolled intercurrent illness that would limit compliance with study requirements.
• Pregnant women or women of childbearing potential with a negative pregnancy test within 14 days prior to admission.
• Patients with any history of malignancy are not eligible.
• Patients who have received endocrine therapy within 5 years prior to the diagnosis of the current malignancy.

Sponsors & Collaborators

• Hongmei Zheng, PhD: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib; abemaciclib; palbociclib; dalpiciclib; Letrozole; Anastrozole; Esomeprazole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Hongmei Zheng, Doctor

CONTACT

+86 18971624606; zhenghongmeicj@163.com

Xinhong Wu, Doctor

CONTACT

+8618971624606; 18971624606@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: December 30, 2024
• First Posted: February 5, 2025
• Study Start: April 1, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share