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Trial Title:
Select the Appropriate Population for Adding CDK4/6i to Neoadjuvant Endocrine Therapy
NCT ID:
NCT05809024
Condition:
Locally Advanced Breast Cancer
Hormone Receptor Positive，HER2-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Letrozole
Study type:
Interventional
Study phase:
Phase 4
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
letrozole
Description:
Hormone receptor positive,HER2 negative participants will receive letrozole as
neoadjuvant endocrine therapy，if don't work, CDK4/6 Inhibitor was added.
Arm group label:
single Arm
Other name:
CDK4/6 Inhibitor
Summary:
Select the appropriate population for adding CDK4/6 inhibitors therapy in high risk early
HR+/HER2-breast cancer based on molecular detection
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Newly treated female patients, ≥18 and ≤75 years;
2. ECOG score 0-1;
3. 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)
4. HR+/HER2- breast cancer confirmed by pathological examination, defined as: primary
HR+/HER2- breast cancer performed by the pathology department of the Central
Hospital;
5. Get hormone receptor status (ER and PR);
6. 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));
7. 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;
8. Volunteer to participate in the study, sign informed consent, have good compliance
and be willing to cooperate with follow-up.
Exclusion Criteria:
1. IV stage breast cancer or metastatic breast cancer;
2. Inflammatory breast cancer;
3. 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;
4. Participate in other clinical trials;
5. 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;
6. Patients were not allowed who had received blood transfusion or colony stimulating
factor treatment within 2 weeks before randomization;
7. Patients were not allowed who allergic to drug components;
8. 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;
9. 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;
10. 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;
11. 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.);
12. Patients were not allowed who with inability to swallow, chronic diarrhea and
intestinal obstruction, accompany multiple factors affecting the administration and
absorption of medicines;
13. Any other circumstances in which the investigator considers the patients unsuitable
for participation in the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast Cancer Center, Shandong Cancer Hospital and Institute
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Recruiting
Contact:
Last name:
yongsheng wang, MD
Phone:
+8613505409989
Email:
wangysh2008@aliyun.com
Contact backup:
Last name:
chunhui zheng, MD
Phone:
+8613656362930
Email:
zhengchunh@outlook.com
Start date:
March 1, 2023
Completion date:
March 25, 2026
Lead sponsor:
Agency:
Yongsheng Wang
Agency class:
Other
Collaborator:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Shandong Cancer Hospital and Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05809024
