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NCT01834950: HERBIN

Identification of Early Markers of Response and Resistance to Trastuzumab

Completed NA Last updated 29 March 2018
What this trial tests

NA trial testing Blood test in Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer in 25 participants. Completed in 10 December 2017.

Timeline
27 March 2013
Primary endpoint
10 December 2017
10 December 2017

Quick facts

Lead sponsorGustave Roussy, Cancer Campus, Grand Paris
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment25
Start date27 March 2013
Primary completion10 December 2017
Estimated completion10 December 2017
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris — full company profile →

Who can join

18 and older, female only, with Untreated Human Epidermal Growth Factor Receptor-2(HER2)Positive Early Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a single arm prospective study, aiming at identifying biomarkers of early response to trastuzumab. It is a prognostic factor study recruiting all consecutive cases of HER-2 positive breast cancer eligible for a pre-operative treatment by trastuzumab, followed by breast conserving surgery. The investigators will study the association between the value of biomarkers measured at diagnosis and the Response Evaluation Criteria in Solid Tumors response (partial and complete response) using a logistic regression (main analysis).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Concordance between HER-2 status determined by qPCR in Fine Needle Aspiration Cytology (FNAC) samples compared with IHC and FISH in Core Needle Biopsy (CNB) or surgical specimens in breast cancer patients.
    Rodriguez C, Suciu V, Poterie A, Lacroix L, et al · · 2016 · cited 2× · PMID 27555543 · DOI 10.1016/j.molonc.2016.07.009

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