NEOZOL_Follow-up Study

Locally Advanced Breast Cancer Clinical Trial

— NEOZOL_FU  

Official title:

Long-term Survival of Locally Advanced Breast Cancer Patients Treated With Neoadjuvant Chemotherapy With or Without Zoledronic Acid (ZOMETA®)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04899713
• Other study ID #: 69HCL21_0552
• Status: Not yet recruiting
• Start date: May 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2021
• Source: Hospices Civils de Lyon
• Contact: MATHEVET, MD
• Phone: 795 567 520
• Email: Patrice.Mathevet[@]chuv.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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®).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Locally Advanced Breast Cancer

Intervention

Other:
• Survival survey
To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	Event-free survival is defined as the time between the date of randomization and the date of the 1st event among: 1st documented locoregional or metastatic infiltrating relapse (not including in situ relapses) or death from whatever cause.	31/12/2019