NEOZOL_Follow-up Study

• Conditions: Locally Advanced Breast Cancer
• Interventions: Other: Survival survey

• Registration Number: NCT04899713
• Lead Sponsor: Hospices Civils de Lyon

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-05
• Study Start: 2021-05
• Study First Submitted: 2021-05-21
• Study First Submitted QC: 2021-05-21
• Last Update Submitted: 2021-05-21
• Study First Posted: 2021-05-24
• Last Update Posted: 2021-05-24
• Primary Completion: 2021-10-30
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group (neo-adjuvant chemotherapy alone)	Survival survey	Patients treated every 3 weeks (+/- 2 days) for 8 cycles in total. The 4 first cycles : doxorubicin (60 mg/m²) combined with cyclophosphamide (600 mg/m²). The 4 last cycles with docetaxel (100 mg/m²)
Experimental group (neo-adjuvant chemotherapy combined with ZOMETA®) (zoledronic acid)	Survival survey	Patients treated every 3 weeks (+/- 2 days ) for 8 cycles in total. The 4 first cycles : zoledronic acid 4 mg (in a 15 min. infusion) + doxorubicin (60 mg/m²) + cyclophosphamide (600 mg/m²). The 4 last cycles with zoledronic acid 4 mg (in a 15 min. infusion) + docetaxel (100 mg/m²)

Primary Outcome Measures

Name	Time	Method
Event-free survival	31/12/2019	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.

Trial Locations

Locations (11)

Hôpital Femme Mère Enfant, Groupement Hospitalier EST, Service de Gynécologie Clinique; 🇫🇷 Bron, France

Centre hospitalier de Bourg en Bresse, Hôpital Fleyriat, Service d'Onco-Hématologie et de Gynécologie Obstétrique; 🇫🇷 Bourg-en-Bresse, France

Centre de Lutte Contre le Cancer - Institut Jean Perrin, Service de Médecine Oncologique; 🇫🇷 Clermont-Ferrand, 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

Centre Hospitalier de Thonon Hôpitaux du Léman, site Georges Pianta Service de Gynécologie Obstétrique; 🇫🇷 Thonon-les-Bains, France

Institut de Cancérologie de la Loire Lucien Neuwirth; 🇫🇷 Saint-Priest-en-Jarez, France

Centre Hospitalier Alpes Léman, Service de Gynécologie; 🇫🇷 Contamine-sur-Arve, France