NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

Recruiting Phase 3 Interventional Study
Triple Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. 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 3
Study type
Interventional
Purpose
Treatment
Participants needed
348 (estimated)
Sponsor
Women's Cancer Study Group GmbH · Other
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About This Trial
TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis c…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer 2. All patients, independent from gender 3. ≥18 years at diagnosis 4. Histologically confirmed unilateral, primary invasive carcinoma…
Contacts

Oleg Gluz, PD Dr.

+492161566230

oleg.gluz@wsg-online.com

CONTACT

Anja Braschoß

+4917682119153

anja.braschoss@wsg-online.com

CONTACT