Recruiting

CDK4/6 Inhibitors and Endocrine Therapy for High-Risk HR+/HER2+ Early Breast Cancer

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What is being tested

Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)

+ Standard endocrine therapy combined with CDK4/6 Inhibitor

Drug
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

From 18 to 70 Years
+19 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorFudan University
Study ContactZhimin Shao, MD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 15, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating how effective and safe it is to add CDK4/6 inhibitors to the usual hormone therapy for patients with a specific type of early breast cancer known as HR+/HER2+. These patients have already completed treatment that targets HER2, a protein that can promote the growth of cancer cells. By adding CDK4/6 inhibitors, which are known to help in more advanced stages of breast cancer, the study aims to see if similar benefits can be observed in patients at an earlier stage. The study targets those deemed high-risk due to their cancer characteristics and aims to improve outcomes for this group by potentially preventing cancer from returning. Participants in this study will receive a combination of CDK4/6 inhibitors and the standard hormone therapy. The treatment involves taking medication orally, and the study is conducted across multiple centers to gather comprehensive data. Researchers will closely monitor participants to evaluate how well the combination works and if there are any side effects. The study does not specify any risks or benefits in advance, but the main goal is to see if this treatment approach offers better protection against cancer recurrence compared to standard treatment alone.

Official TitleA Study on the Efficacy and Safety of CDK4/6 Inhibitors Combined With Standard Adjuvant Endocrine Therapy in High-Risk, HR+/HER2+ Early Breast Cancer Patients Who Have Completed Adjuvant Anti-HER2 Targeted Therapy"
NCT07019363
Principal SponsorFudan University
Study ContactZhimin Shao, MD, PhDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1903 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

8 inclusion criteria required to participate
ECOG systemic status grade 0 to 1.
Early-stage breast cancer after radical mastectomy with postoperative pathology consistent with TNM staging of ≥pN1 ; or postoperative pathology suggestive of non-pCR after neoadjuvant therapy; or postoperative pathology suggestive of pCR after neoadjuvant therapy but with clinical staging consistent with cT4 or N3 before neoadjuvant therapy
Subjects voluntarily enrolled in the study, signed an informed consent form, were compliant, and cooperated with follow-up visits.
Females aged ≥18 and ≤70 years.
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11 exclusion criteria prevent from participating
Taking food or medications that are strong inhibitors or inducers of CYP3/4. Strong inhibitors of CYP3/4 include: boceprevir, clarithromycin, konifactam, delavirdine, indinavir, itraconazole, ketoconazole, ritonavir, mibefradil, miconazole, fazodone, nelfinavir, propoxiconazole, ritonavir, saquinavir, naloxone, telaprevir, telithromycin, voriconazole, grapefruit, grapefruit juice, or grapefruit containing foods. Strong inducers of CYP3/4 including carbamazepine, phenytoin, pramipexole, rifampin, and St. John's wort.
Bilateral breast cancer.
Metastasis to any site.
History of clinically significant or uncontrolled cardiac disease including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
endocrine therapy

Group II

Experimental
Standard endocrine therapy combined with CDK4/6i

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Fudan cancer center

Shanghai, ChinaOpen Fudan cancer center in Google Maps
Recruiting
One Study Center