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 | Biotech Hunter

Enrollment

200

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

January 31, 2027

Study Completion Date

January 31, 2028

Conditions

Advanced Breast CancerAdvanced Breast CarcinomaHormone Receptor Positive Breast Carcinoma

Interventions

DRUG

Trastuzumab deruxtecan (T-DXd, DS-8201a)

Patients will receive T-DXd 5.4 mg/kg body weight administered as an intravenous (IV) infusion on Day 1 (D1) of each 21-day cycle. The initial dose will be administered as a 90-minute IV infusion.

DRUG

CDK4/6i plus ET

Patients will receive physician's choice of CDK4/6 inhibitor (CDK4/6i) including palbociclib, ribociclib, and abemaciclib; physician's choice of endocrine therapy (ET) including fulvestrant, letrozole, anastrozole, and exemestane.

Trial Locations (8)

15006

RECRUITING

Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña

28007

RECRUITING

Hospital Beata María Ana, Madrid

29010

RECRUITING

Hospital Universitario Virgen de la Victoria, Málaga

80131

RECRUITING

Federico II Napoli, Napoli

03550

RECRUITING

Hospital Universitario San Juan de Alicante, Alicante

08017

RECRUITING

UOMI Cancer Center, Barcelona

08036

RECRUITING

Hospital Clínic i Provincial de Barcelona, Barcelona

Unknown

RECRUITING

Hospital Arnau de Vilanova de Valencia, Valencia

All Listed Sponsors

lead

MedSIR

OTHER