Spots Global Cancer Trial Database for Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer
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Trial Identification
Brief Title: Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer
Official Title: A Prospective Multicenter Open-label, Randomized Phase II Study of Pembrolizumab in Combination With Neoadjuvant EC-Paclitaxel Regimen in HER2-negative Inflammatory Breast Cancer.
Study ID: NCT03515798
Conditions
Study Description
Brief Summary: This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.
Detailed Description: Inflammatory breast cancer (IBC) is a rare and highly aggressive subtype of locally advanced breast cancer representing approximately 5% of all breast cancers that requires immediate aggressive treatment. Significant progress has been made in recent years using a combination of treatments, including neoadjuvant chemotherapy, surgery and radiation therapy. Accumulating data indicate a prognostic and/or predictive impact for immune-response variables in BC. Recent data, suggest that PD-L1 is overexpressed in a significant number of BC, notably in IBC and may have significant prognostic or predictive value. Furthermore it may be targeted to restore or boost functional antitumor immunity. Pembrolizumab, a PD-1-directed monoclonal antibody is already registered and has an out-standing activity in advanced melanoma and NSCLC patients, with promising results in several other tumor types, including triple-negative BC, and a favorable profile of tolerance. Thus, potential benefits of pembrolizumab in combination with a conventional cytotoxic backbone may be considered as high in HER2-negative IBC. The aim of the study is to assess the pathological complete response rate following neoadjuvant EC-paclitaxel chemotherapy plus pembrolizumab and to assess if neoadjuvant chemotherapy with anthracycline-based induction in combination with pembrolizumab exposes IBC patients to significant toxicity. rates.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sint-Augustinus Hospital, Antwerp, , Belgium
Jules Bordet, Bruxelles, , Belgium
Grand Hôpital de Charleroi, Charleroi, , Belgium
UZ Gand, Gand, , Belgium
UCL, Louvain, , Belgium
CHU Ambroise Pare, Mons, , Belgium
Saint Elisabeth, Namur, , Belgium
Clinique de L'Europe, Amiens, , France
Institut Sainte Catherine, Avignon, , France
Institut BERGONIE, Bordeaux, , France
CENTRE Francois Baclesse, Caen, , France
Centre Leon Berard, Lyon, , France
Institut Curie, Paris, , France
Centre Henri Becquerel, Rouen, , France
Institut Curie hopital rene huguenin, Saint-Cloud, , France
Institut de cancérologie de la loire, Saint-Priest-en-Jarez, , France
Centre Paul Strauss, Strasbourg, , France
IUCT-Oncopole Institut Claudius Rigaud, Toulouse, , France
Contact Details
Name: Anthony Goncalves, Pr
Affiliation: Institut Paoli-Calmettes
Role: PRINCIPAL_INVESTIGATOR
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