Clinical trial NCT04899713: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Locally Advanced Breast Cancer
Keywords: Breast cancer
Zometa®
Survival survey
Neoadjuvant chemotherapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of 50 patients with locally advanced breast cancer (TNM IIa or IIb or IIIa, tumor \> 2 cm, ductal or lobular histology), who benefited from neoadjuvant chemotherapy associated ( n = 26) or not (n = 24) with the zoledronic acid, and having participated in the NEOZOL study (NCT01367288)

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®).


Eligibility criteria: Inclusion Criteria:

* Woman who signed a written consent, included and randomised in the main analysis of the NEOZOL study

Exclusion Criteria:

* Patient's opposition to the use of her data in this study

Primary outcomes:
measure: Event-free survival
timeFrame: 31/12/2019
Secondary outcomes:
Other outcomes:
Locations:
city: Bourg-en-Bresse
country: France
facility: Centre hospitalier de Bourg en Bresse, Hôpital Fleyriat, Service d'Onco-Hématologie et de Gynécologie Obstétrique
city: Bron
country: France
facility: Hôpital Femme Mère Enfant, Groupement Hospitalier EST, Service de Gynécologie Clinique
city: Clermont-Ferrand
country: France
facility: Centre de Lutte Contre le Cancer - Institut Jean Perrin, Service de Médecine Oncologique
city: Contamine-sur-Arve
country: France
facility: Centre Hospitalier Alpes Léman, Service de Gynécologie
city: Limoges
country: France
facility: Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren 1, Service d'Oncologie Médicale,
city: Lyon
country: France
facility: Centre Léon Bérard, Département de Cancérologie Médicale
city: Marseille
country: France
facility: Hôpital Européen, Service d'Oncologie
city: Montpellier
country: France
facility: Centre Hospitalier Universitaire de Montpellier - Hôpital St Eloi
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire de Poitiers, Hôpital la Milétrie
city: Saint-Priest-en-Jarez
country: France
facility: Institut de Cancérologie de la Loire Lucien Neuwirth
city: Thonon-les-Bains
country: France
facility: Centre Hospitalier de Thonon Hôpitaux du Léman, site Georges Pianta Service de Gynécologie Obstétrique
Study officials:
References: