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RecruitingNCT05809024Updated Apr 12, 2023

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

A Phase 4 interventional study of letrozole in Locally Advanced Breast Cancer and Hormone Receptor Positive,HER2-negative Breast Cancer, sponsored by Yongsheng Wang. Recruiting at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-04-12.

Sponsored by Yongsheng Wang · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Mar 2023; still recruiting 3 years 7 months later.
Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
Female
01

Study summary

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

02

Conditions studied

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

Browse trials for

03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 100 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Yongsheng Wang is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    single Arm

    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

  • Drugletrozole

    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

06

What researchers measure

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).

    Time frame: Up to approximately 2 weeks

Secondary outcomes

  1. 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.

    Time frame: Up to approximately 7 weeks

07

Study locations

1 of 1 sites recruiting
  • Breast Cancer Center, Shandong Cancer Hospital and Institute
    Jinan, Shandong 250117, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05809024
Lead sponsor
Yongsheng Wang
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Yongsheng Wang (Director of breast cancer center, Shandong Cancer Hospital and Institute, Shandong Cancer Hospital and Institute) — Sponsor-investigator
First posted
Apr 12, 2023
Start date
Mar 1, 2023
Primary completion
Mar 25, 2025 (estimated)
Completion
Mar 25, 2026 (estimated)
Last update
Apr 12, 2023

Study contacts

yongsheng wang, MD
Contact
wangysh2008@aliyun.com
+8613605409989
chunhui zheng, MD
Contact
zhengchunhui@mail.sdu.edu.cn
+8613656362930
yongsheng wang
principal investigator · Shandong Cancer Hospital and Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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