RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Trastuzumab deruxtecan (T-DXd, DS-8201a) for Advanced Breast Cancer

This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50). Patients will be treated with trastuzumab deruxtecan (T-DXd) or with physician's choice of CDK4/6 inhibitor (CDK4/6i) plus endocrine therapy (ET).

Official registry: https://clinicaltrials.gov/study/NCT06486883 · MedSIR · enrollment listed as 200

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Trastuzumab deruxtecan (T-DXd, DS-8201a), or CDK4/6i plus ET. The registry lists allocation as randomized. This trial studies a type of advanced breast cancer defined as hormone receptor HR-positive/HER2-negative and classified as non-luminal by gene expression profiling (PAM50).

They plan to enroll about 200 people at 79 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Randomized Phase II Study to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan Versus CDK4/6 Inhibitor-based Endocrine Therapy as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype According to Gene Expression Profiling.

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

Primary outcome (registry wording): Progression-free survival (PFS)

Who it is for (from inclusion criteria)

Ages 18 Years to any
Female or male patients ≥ 18 years of age at the time of signing ICF
how well you can do daily activities (ECOG score) of 0-1
Minimum life expectancy of ≥ 12 weeks at screening
Patients must have HR-positive (estrogen receptor \[ER\] and/or progesterone receptor \[PgR\]-positive defined as ≥ 1% positive stained cells) status according to the most recent ASCO/CAP guidelines locally determined prior to study entry
Unresectable locally recurrent or metastatic breast cancer documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to resection with curative intent
Evaluable disease according to RECIST v.1.1. Patients with bone-only disease are not allowed. Patients with bone metastases with soft tissue masses measuring \> 10 mm are eligible
Patients must have endocrine resistance criteria:

Who the registry excludes

Current participation in another therapeutic clinical trial, except other translational studies
Treatment with approved or investigational cancer therapy within 3 weeks prior to initiation of study drug
Treatment with chloroquine/hydroxychloroquine within 14 days prior to initiation of study drug
Have previously been treated with T-DXd and/or fulvestrant. Note: patients who experienced relapse after more than 1 year from completion of fulvestrant are eligible
Note I: previous treatment with anti-HER2 therapies in (neo-) adjuvant setting will be allowed for participants who showed conversion from HER2-positive expression in primary breast tumor sample to HER2-low or HER2-ultralow expression (HER2 loss) in relapsed tumor sample
Patients with advanced, symptomatic, visceral spread, that are at risk of life-threatening complications in the short term (including patients with massive uncontrolled effusions \[pleural, pericardial, and/or peritoneal\] and pulmonary lymphangitis)
Known allergy or hypersensitivity reaction to any of the investigational medicinal products (IMPs) or their inactive ingredients

Public study contact (from the registry)

MEDSIR

+ 34 932 214 135

contact.trials@medsir.org

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

79 listed

Medizinische Universität Graz — Graz, Austria (recruiting)
Kepler Universitäts Klinikum — Linz, Austria (recruiting)
Medical University of Vienna — Vienna, Austria (recruiting)
Algemeen Ziekenhuis Klina — Brasschaat, Belgium (recruiting)
Ghent University Hospital — Ghent, Belgium (recruiting)
CHU Helora - Hopital de Mons — Mons, Belgium (recruiting)
Cliniques universitaires Saint-Luc — Woluwe-Saint-Lambert, Belgium (recruiting)
Centre Francois Baclesse — Caen, France (recruiting)
CHU Lyon Sud — Lyon, France (recruiting)
Institute Paoli Calmettes — Marseille, France (recruiting)
Institut Curie — Paris, France (recruiting)
CHU Saint Etienne — Saint-Priest-en-Jarez, France (recruiting)

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FAQ about this NCT record

Is NCT06486883 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06486883?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06486883?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary