Clinical trial · Interventional
De-escalation Therapy in Stage I ER-Positive Breast Cancer: A Non-Inferiority Trial
A Prospective, Randomized, Open-label, Non-inferiority, Phase III Study Evaluating the Efficacy and Safety of 2 to 3 Years of Adjuvant Endocrine De-escalation Therapy for ER-positive/HER2-negative Stage I Breast Cancer
NCT07153757CI-TRIAL-00094524DESCENTnot yet recruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Early Stage Breast Cancer (Stage 1-3) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endocrine Therapy of Physician's Choice | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 5 years of standard endocrine therapy
- description
- The control group receives 5 years of standard endocrine therapy: Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 5 years) or Toremifene (60 mg, orally, once daily, for 5 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 5 years) or Anastrozole (1 mg, orally, once daily, for 5 years) or Exemestane (25 mg, orally, once daily, for 5 years); A sequential regimen of 2-3 years of Tamoxifen or Toremifene followed by 3-2 years of Letrozole, Anastrozole, or Exemestane is acceptable. Ovarian function suppression is permitted for premenopausal patients. CDK4/6 inhibitors are not allowed during the treatment course
- interventionNames
- Drug: Endocrine Therapy of Physician's Choice
- type
- EXPERIMENTAL
- label
- 2-3 years of de-escalated endocrine therapy
- description
- The experimental group receives 2-3 years of endocrine therapy: Premenopausal patients: Tamoxifen (10 mg, orally, twice daily, for 2-3 years) or Toremifene (60 mg, orally, once daily, for 2-3 years); Postmenopausal patients: Letrozole (2.5 mg, orally, once daily, for 2-3 years) or Anastrozole (1 mg, orally, once daily, for 2-3 years) or Exemestane (25 mg, orally, once daily, for 2-3 years). Ovarian function suppression is permitted for premenopausal patients. CDK4/6 inhibitors are not allowed during the treatment course.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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%; * Presence of at least one of the following potential low-risk factors: 1）Tumor size ≤1 cm, 2）21-gene recurrence score \<11, 3）Fudan digital pathological subtype classified as SNF1, 4）Age ≥65 years; * ECOG performance status of 0 or 1; * Patients with bilateral synchronous invasive lesions are eligible if both lesions are ER-positive, HER2-negative, and meet the tumor size criteria; * Normal major organ function, meeting the following criteria: 1. Hematological: HB ≥90 g/L (no transfusion within 14 days), ANC ≥1.5×10⁹/L, PLT ≥100×10⁹/L; 2. Biochemical: TBIL ≤1.5×ULN, ALT and AST ≤3×ULN, serum Cr ≤1×ULN, and creatinine clearance \>50 mL/min (Cockcroft-Gault formula); * Participants voluntarily enroll, sign informed consent, demonstrate good compliance, and cooperate with follow-up. Exclusion Criteria: * 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; * History of other malignancies (except cured basal cell carcinoma or cervical carcinoma in situ); * Metastasis at any site; * Pregnancy, lactation, or women of childbearing potential unable to use effective contraception; * Concurrent participation in other clinical trials; * Severe cardiac, pulmonary, hepatic, or renal dysfunction; LVEF \<50% (by echocardiography); severe cardio-cerebrovascular diseases within 6 months (e.g., unstable angina, chronic heart failure, uncontrolled hypertension \>150/90 mmHg, myocardial infarction, or stroke); poorly controlled diabetes; severe hypertension; * Severe or uncontrolled infections; * History of drug abuse or psychiatric disorders; * Patients deemed unsuitable for the study by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.