# Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype

> **NCT06486883** · PHASE2 · RECRUITING · sponsor: **MedSIR** · enrollment: 200 (estimated)

## Conditions studied

- Advanced Breast Cancer
- Advanced Breast Carcinoma
- Hormone Receptor Positive Breast Carcinoma

## Interventions

- **DRUG:** Trastuzumab deruxtecan (T-DXd, DS-8201a)
- **DRUG:** CDK4/6i plus ET

## Key facts

- **NCT ID:** NCT06486883
- **Lead sponsor:** MedSIR
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-06-30
- **Primary completion:** 2027-01
- **Final completion:** 2028-01
- **Target enrollment:** 200 (ESTIMATED)
- **Last updated:** 2026-04-02


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06486883

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06486883, "Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT06486883. Licensed CC0.

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