NeoAdjuvant Therapy With Trastuzumab-deruxtecan Versus Chemotherapy+Trastuzumab+Pertuzumab in HER2+ Early Breast Cancer

Recruiting Phase 2 Interventional Study
HER2-positive Early Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
702 (estimated)
Sponsor
Women's Cancer Study Group GmbH · Other
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About This Trial
ADAPT-HER2-IV will address question of optimal neoadjuvant therapy in patients with less advanced -HER2+ EBC. ADAPT-HER2-IV is planned as a superiority trial to demonstrate higher pCR rates in both clinically relevant subgroups of low-intermediate risk HER2+ EBC. Moreover, it aims to demonstrate excellent survival in patients treated by T-DXd (with the use of standard chemotherapy at investigator…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Patients eligible for inclusion in this study must meet all the following criteria: 1\. Female patients with invasive, untreated HER2+ breast cancer (as assessed by local pathology) maximum 6 weeks before registration (standard-of-care diagnostic biopsy according to current AGO…
Contacts

Anja Braschoß, MD

+4917682119153

anja.braschoss@wsg-online.com

CONTACT

Pauline Tholen

+492161566230

pauline.tholen@wsg-online.com

CONTACT