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De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial

ConditionBreast Cancer Early Stage Breast Cancer (Stage 1-3)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Endocrine Therapy of Physician's Choice

    Drug

    This study employs a 2-3 year de-escalated endocrine therapy regimen in the experimental group, which distinguishes it from other escalation therapy studies.

Treatment groups

2,934 Participants
are divided into 2 treatment groups
Group A: 5 years of standard endocrine therapyActive comparator 1 intervention
Group B: 2-3 years of de-escalated endocrine therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

5-year disease-free survival in the per-protocol population

The proportion of patients in a clinical trial who remained free of disease recurrence, secondary primary cancers, and death from the disease for five years following treatment initiation, calculated specifically among those who completed the study intervention as predefined in the trial protocol(i.e., without major deviations such as incomplete treatment, use of prohibited therapies, or significant protocol violations).

Time frame
5 year

Secondary outcomes

1

5-year disease-free survival in the Full Analysis Set

The proportion of patients in a clinical trial who remained free of disease recurrence, secondary primary cancers, and death from the disease for five years after randomization or initiation of treatment, analyzed within the Full Analysis Set (FAS) population-which includes all subjects randomized (or initially assigned to a treatment group) following the intention-to-treat (ITT) principle, regardless of whether they fully received, discontinued, or deviated from the protocol.

Time frame
5 year
2

5-year invasive breast cancer-free survival in the per-protocol population

The proportion of participants in a clinical trial who, after receiving the full intended course of treatment without major protocol deviations, remained free of invasive ipsilateral or contralateral breast cancer recurrence, distant metastatic invasive breast cancer, and death from any cause for a period of five years from the start of treatment or randomization.

Time frame
5 year
3

Overall survival in the per-protocol population

The length of time from randomization or initiation of treatment until death from any cause, measured specifically among participants who completed the study intervention without major protocol deviations, such as insufficient treatment exposure, use of prohibited therapies, or significant violations of inclusion/exclusion criteria.

Time frame
5 year
4

Quality of Life score in the per-protocol population

The quality of life of patients was assessed using the EORTC QLQ-C30 questionnaire before, during, and after treatment.

Time frame
5 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: