De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University
About this trial
This study is a prospective, randomized, open-label, non-inferiority Phase III clinical trial, planning to enroll 2,934 patients, with a 1:1 allocation to either the conventional endocrine therapy group or the de-escalation therapy group. The aim is to evaluate the safety and efficacy of 2-3 years of de-escalated endocrine therapy in patients with T1N0M0 potentially low-risk breast cancer, respectively.
Eligibility criteria
Qualifiers
Females aged 18 years or older;
Postoperative pathological stage I early breast cancer: histologically confirmed invasive carcinoma with a maximum diameter ≤2 cm and node-negative (N0);
Immunohistochemistry (IHC) shows ER-positive (ER ≥50%), HER2 IHC score of 0, 1+, or 2+ with no amplification confirmed by FISH, and Ki-67 ≤20%;
ECOG performance status of 0 or 1;
Disqualifiers
Primary tumor size >2 cm in maximum diameter and/or axillary lymph node positivity;
Prior neoadjuvant therapy, any systemic therapy, or local therapy (except surgery), including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy;
Prior adjuvant chemotherapy;
Use of CDK4/6 inhibitors in the adjuvant setting;
Trial design
Treatments tested in this trial
- Endocrine Therapy of Physician's Choice
Treatment groups
2,934 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov