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

Primary Purpose

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

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
letrozole
Sponsored by
Yongsheng Wang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Breast Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Breast Cancer Center, Shandong Cancer Hospital and InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single Arm

Arm Description

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Objective Overall Response Rate
Defined as the proportion of subjects who achieved CR or PR as optimal tumor response during neoadjuvant therapy. Objective response rates will be assessed according to the RECIST v1.1 for the evaluation of efficacy in solid tumors.

Full Information

First Posted
March 29, 2023
Last Updated
April 11, 2023
Sponsor
Yongsheng Wang
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05809024
Brief Title
Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy
Official Title
Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy in High Risk Early HR+/HER2-breast Cancer Based on Molecular Marker
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2023 (Actual)
Primary Completion Date
March 25, 2025 (Anticipated)
Study Completion Date
March 25, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yongsheng Wang
Collaborators
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Breast Cancer, Hormone Receptor Positive,HER2-negative Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single Arm
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
letrozole
Other Intervention Name(s)
CDK4/6 Inhibitor
Intervention Description
Hormone receptor positive,HER2 negative participants will receive letrozole as neoadjuvant endocrine therapy,if don't work, CDK4/6 Inhibitor was added.
Primary Outcome Measure Information:
Title
ki67 index
Description
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).
Time Frame
Up to approximately 2 weeks
Secondary Outcome Measure Information:
Title
Objective Overall Response Rate
Description
Defined as the proportion of subjects who achieved CR or PR as optimal tumor response during neoadjuvant therapy. Objective response rates will be assessed according to the RECIST v1.1 for the evaluation of efficacy in solid tumors.
Time Frame
Up to approximately 7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
yongsheng wang, MD
Phone
+8613605409989
Email
wangysh2008@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
chunhui zheng, MD
Phone
+8613656362930
Email
zhengchunhui@mail.sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yongsheng wang
Organizational Affiliation
Shandong Cancer Hospital and Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Breast Cancer Center, Shandong Cancer Hospital and Institute
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250117
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yongsheng wang, MD
Phone
+8613505409989
Email
wangysh2008@aliyun.com
First Name & Middle Initial & Last Name & Degree
chunhui zheng, MD
Phone
+8613656362930
Email
zhengchunh@outlook.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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