Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy

NCT05809024 | Recruiting Phase 4

• 1 other identifier: MA-BC-II-023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early HR+/HER2-breast cancer based on molecular detection

Conditions

Locally Advanced Breast Cancer; Hormone Receptor Positive，HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• ki67 index

  Independent review committee (IRC) evaluates the Ki67 index after treatment. Ki67 index using the definition of HE stained breast cancer samples after neoadjuvant therapy and surgery. (Defined by the American Joint Committee onCancer, AJCC).

  Up to approximately 2 weeks

Secondary Outcomes (1)

• Objective Overall Response Rate

  Up to approximately 7 weeks

Study Arms (1)

single Arm

EXPERIMENTAL

Hormone receptor positive,HER2 negative participants will receive letrozole as neoadjuvant endocrine therapy，if ki67 was higher than 10% after two weeks,CDK4/6 Inhibitor was added.

Drug: letrozole

Interventions

letrozole DRUG

Hormone receptor positive,HER2 negative participants will receive letrozole as neoadjuvant endocrine therapy，if don't work, CDK4/6 Inhibitor was added.

Also known as: CDK4/6 Inhibitor

single Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Newly treated female patients, ≥18 and ≤75 years;
• ECOG score 0-1;
• Breast cancer following:
• Histologically confirmed invasive breast cancer with primary tumor diameter \>2 cm by standard evaluation methods.Tumor stage: cT2-cT4/cN0-cN3/cM0 (clinical phase II and III)
• HR+/HER2- breast cancer confirmed by pathological examination, defined as: primary HR+/HER2- breast cancer performed by the pathology department of the Central Hospital;
• Get hormone receptor status (ER and PR);
• Major organ function following:
• Complete blood count: Neutrophil (ANC) ≥ 1.5×109/L; Platelet count (PLT) ≥ 90×109/L; hemoglobin (Hb) ≥90 g/L; Blood Biochemistry: Total bilirubin (TBIL) ≤ 2.5×ULN; Alanine aminotransferase (ALT) ≤ 1.5×ULN; Aspartate aminotransferase (AST) ≤ 1.5×ULN; Alkaline phosphatase ≤ 2.5×ULN; Urea nitrogen (BUN) ≤ 1.5×ULN; Creatinine (Cr) ≤ 1.5×ULN; Twelve-lead electrocardiogram: Fridericia corrected QT Interval (QTcF) woman \< 470 ms (QTcF=QT/(RR\^1/3));
• Woman who are not menopausal or have not been surgically sterilized agree to abstain from sex or use effective contraceptive methods for at least the duration of the study treatment and for 7 months after the last dosing;
• Volunteer to participate in the study, sign informed consent, have good compliance and be willing to cooperate with follow-up.

You may not qualify if:

• IV stage breast cancer or metastatic breast cancer;
• Inflammatory breast cancer;
• Any previous malignant tumor or previous anti-tumor therapy or radiotherapy were not allowed, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma;
• Participate in other clinical trials;
• Patients were not allowed who had undergone major non-breast cancer related surgery within 4 weeks prior to randomization or had not fully recovered from such surgery;
• Patients were not allowed who had received blood transfusion or colony stimulating factor treatment within 2 weeks before randomization;
• Patients were not allowed who allergic to drug components;
• Patients were not allowed who had a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or a history of organ transplantation;
• Patients have heart disease were not allowed including: (1) angina pectoris; (2) medically treatable or clinically significant arrhythmias; (3) myocardial infarction; (4) heart failure; (5) any other heart disease that the investigator has determined is not suitable for participation in the study;
• Pregnant and lactating women, fertile women who tested positive for baseline pregnancy tests, or fertile women who were unwilling to take effective contraceptive measures during the test period were not allowed;
• Patients have concomitant diseases that endanger patient safety or influence the completion of the study were not allowed (including but not limited to hypertension, severe diabetes, active infection, thyroid disease, etc.);
• Patients were not allowed who with inability to swallow, chronic diarrhea and intestinal obstruction, accompany multiple factors affecting the administration and absorption of medicines;
• Any other circumstances in which the investigator considers the patients unsuitable for participation in the study.

Sponsors & Collaborators

• Yongsheng Wang: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Breast Cancer Center, Shandong Cancer Hospital and Institute

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• yongsheng wang

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

yongsheng wang, MD

CONTACT

+8613605409989; wangysh2008@aliyun.com

chunhui zheng, MD

CONTACT

+8613656362930; zhengchunhui@mail.sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of breast cancer center, Shandong Cancer Hospital and Institute

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 12, 2023
• Study Start: March 1, 2023
• Primary Completion: March 25, 2025
• Study Completion: March 25, 2026
• Last Updated: April 12, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)