Spots Global Cancer Trial Database for NEOZOL_Follow-up Study
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Trial Identification
Brief Title: NEOZOL_Follow-up Study
Official Title: Long-term Survival of Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy With or Without Zoledronic Acid (ZOMETA®)
Study ID: NCT04899713
Conditions
Interventions
Study Description
Brief Summary: Breast cancer is the most common cancer in women and is the leading cause of death from cancer in France. The main types of treatment used to treat breast cancer are surgery, chemotherapy, radiotherapy, hormone therapy and targeted therapies. In locally advanced breast cancer, a neo-adjuvant chemotherapy treatment is currently recommended as it may provide a sufficient tumour response to allow for conservative breast treatment. Zoledronic acid (ZOL) is an N-biphosphonate used in the prevention of bone complications and in the treatment of hypercalcaemia In vitro and in vivo studies have shown an effect of ZOL on tumour and endothelial cells, supporting an anti-tumour activity of N-biphosphonates. Between April 2010 and October 2013, 50 patients with locally advanced breast cancer were randomized in the NEOZOL study to receive neoadjuvant chemotherapy with (n=26) or without (n=24) zoledronic acid (ClinicalTrials.gov Identifier: NCT01367288). The primary objective of this study was to evaluate the effect of the addition of ZOMETA® to neoadjuvant chemotherapy on the change in serum VEGF concentration before and after neoadjuvant treatment (i.e. at the time of surgery). Assessment of long-term survival was not planned in the NEOZOL study protocol. The objective of NEOZOL_FU study is to evaluate the survival of patients included in the NEOZOL study, 7 years after inclusion of the last patient. This study will provide essential data on the long-term survival and risk of relapse of patients with locally advanced breast cancer who have received neo-adjuvant chemotherapy with or without zoledronic acid (ZOMETA®).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Centre hospitalier de Bourg en Bresse, Hôpital Fleyriat, Service d'Onco-Hématologie et de Gynécologie Obstétrique, Bourg-en-Bresse, , France
Hôpital Femme Mère Enfant, Groupement Hospitalier EST, Service de Gynécologie Clinique, Bron, , France
Centre de Lutte Contre le Cancer - Institut Jean Perrin, Service de Médecine Oncologique, Clermont-Ferrand, , France
Centre Hospitalier Alpes Léman, Service de Gynécologie, Contamine-sur-Arve, , France
Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren 1, Service d'Oncologie Médicale,, Limoges, , France
Centre Léon Bérard, Département de Cancérologie Médicale, Lyon, , France
Hôpital Européen, Service d'Oncologie, Marseille, , France
Centre Hospitalier Universitaire de Montpellier - Hôpital St Eloi, Montpellier, , France
Centre Hospitalier Universitaire de Poitiers, Hôpital la Milétrie, Poitiers, , France
Institut de Cancérologie de la Loire Lucien Neuwirth, Saint-Priest-en-Jarez, , France
Centre Hospitalier de Thonon Hôpitaux du Léman, site Georges Pianta Service de Gynécologie Obstétrique, Thonon-les-Bains, , France
Contact Details
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