Actively Recruiting
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
Led by SOLTI Breast Cancer Research Group · Updated on 2026-03-27
300
Participants Needed
27
Research Sites
227 weeks
Total Duration
On this page
Sponsors
S
SOLTI Breast Cancer Research Group
Lead Sponsor
W
Westdeutsche Studiengruppe GmbH (WSG)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300). The study integrates digital health tools for proactive toxicity management and potentially facilitate early detection of ILD/pneumonitis.
CONDITIONS
Official Title
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand the study and provide written informed consent, with capacity to use digital health tools.
- Male or female patients aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Histologically or cytologically confirmed HER2-positive breast cancer locally advanced or metastatic, with HER2 status defined as IHC 3+ or ISH+ by local testing.
- Documented hormone receptor positive or negative status confirmed locally.
- No prior chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer; prior adjuvant chemotherapy or HER2 therapy allowed.
- Measurable or evaluable disease as per RECIST v1.1 criteria.
- Adequate tumor tissue sample available from metastatic disease for central HER2 analysis.
- Patients with brain metastases are eligible if stable, asymptomatic, and not requiring immediate local therapy.
- Adequate blood counts and organ function based on laboratory tests.
- Left ventricular ejection fraction (LVEF) of 50% or higher within 28 days before treatment start.
- Life expectancy of at least 12 weeks at screening.
- Completed required washout periods before starting study treatment.
- Agreement to use effective contraception if of childbearing potential and sexually active.
- Access to a smartphone with internet and compatible operating system for the study app.
- For patients in France, must be affiliated with the social security system.
You will not qualify if you...
- HER2-negative breast cancer.
- Unable to comply with study requirements or provide informed consent, including insufficient language skills for study materials.
- History of other primary cancers within 3 years, except certain low-risk or treated skin, cervical, or breast cancers.
- Unresolved toxicities from prior anti-cancer therapy above grade 1, except stable grade 2 toxicities under management.
- Untreated spinal cord compression.
- Significant cardiovascular disease including advanced heart failure, recent heart attack, serious arrhythmias, or low LVEF below 50%.
- History or current interstitial lung disease or pneumonitis requiring steroids, or suspected lung inflammation not ruled out.
- Serious lung diseases or autoimmune disorders with lung involvement.
- Received live attenuated vaccines within 30 days before treatment.
- Active serious infections requiring intravenous treatment.
- Active untreated HIV, hepatitis B or C infections according to specified criteria.
- Medical or psychiatric conditions that may interfere with study participation.
- Prior chemotherapy or HER2 therapy for advanced or metastatic breast cancer.
- Prior exposure to antibody-drug conjugates containing exatecan derivative within 12 months.
- Use of prohibited medications or participation in conflicting clinical trials within specified time frames.
- Known allergy to study drugs or related compounds.
- Positive pregnancy test or currently breastfeeding.
- For France only, patients deprived of liberty or under guardianship.
AI-Screening
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Trial Site Locations
Total: 27 locations
1
Gustave Roussy
Villejuif, France, 94805
Not Yet Recruiting
2
Klinikum der Universitaet Muenchen AöR
München, Germany
Not Yet Recruiting
3
Hospital Universitari Vall d'Hebrón
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
4
Complexo Hospitalario Universitario A Coruna
A Coruña, Spain
Not Yet Recruiting
5
Hospital General Universitario Dr. Balmis
Alicante, Spain
Actively Recruiting
6
Hospital Universitario de Badajoz
Badajoz, Spain
Actively Recruiting
7
Hospital Clínic de Barcelona
Barcelona, Spain
Actively Recruiting
8
Hospital Universitario de Basurto
Bilbao, Spain
Not Yet Recruiting
9
Institut Català d'Oncologia (ICO) Girona
Girona, Spain
Not Yet Recruiting
10
Hospital Universitario Clínico San Cecilio
Granada, Spain
Actively Recruiting
11
Institut Català d'Oncologia (ICO) Hospitalet
L'Hospitalet de Llobregat, Spain
Not Yet Recruiting
12
Hospital Universitario Leon
León, Spain
Actively Recruiting
13
Hospital Universitari Arnau De Vilanova De Lleida
Lleida, Spain
Not Yet Recruiting
14
Hospital 12 Octubre
Madrid, Spain
Actively Recruiting
15
Hospital Universitario De Fuenlabrada
Madrid, Spain
Not Yet Recruiting
16
Hospital Universitaro Ramón y Cajal
Madrid, Spain
Not Yet Recruiting
17
Hospital Regional Universitario de Málaga
Málaga, Spain
Actively Recruiting
18
Hospital Son Espases
Palma de Mallorca, Spain
Actively Recruiting
19
Hospital Sant Joan de Reus
Reus, Spain
Actively Recruiting
20
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Not Yet Recruiting
21
Hospital Universitario de Valdecilla
Santander, Spain
Not Yet Recruiting
22
Centro Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela, Spain
Not Yet Recruiting
23
Hospital Universitario Virgen Del Rocío
Seville, Spain
Not Yet Recruiting
24
Hospital Clinico Universitario de Valencia
Valencia, Spain
Not Yet Recruiting
25
Instituto Valenciano de Oncologia (IVO)
Valencia, Spain
Not Yet Recruiting
26
Hospital Clínico Universitario de Valladolid
Valladolid, Spain
Actively Recruiting
27
Hospital Universitario Lozano Blesa
Zaragoza, Spain
Actively Recruiting
Research Team
M
Mariana Paes Dias, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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