NEOZOL_Follow-up Study

NCT04899713 | Unknown

• 1 other identifier: 69HCL21_0552
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 11

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®).

Conditions

Locally Advanced Breast Cancer

Keywords

Breast cancer; Zometa®; Survival survey; Neoadjuvant chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental group (neo-adjuvant chemotherapy combined with ZOMETA®) (zoledronic acid)

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)

Other: Survival survey

Control group (neo-adjuvant chemotherapy alone)

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)

Other: Survival survey

Interventions

Survival survey OTHER

To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.

Control group (neo-adjuvant chemotherapy alone); Experimental group (neo-adjuvant chemotherapy combined with ZOMETA®) (zoledronic acid)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (11)

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

Bourg-en-Bresse, 01012, France

Location

Hôpital Femme Mère Enfant, Groupement Hospitalier EST, Service de Gynécologie Clinique

Bron, 69677, France

Location

Centre de Lutte Contre le Cancer - Institut Jean Perrin, Service de Médecine Oncologique

Clermont-Ferrand, 63011, France

Location

Centre Hospitalier Alpes Léman, Service de Gynécologie

Contamine-sur-Arve, 74130, France

Location

Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren 1, Service d'Oncologie Médicale,

Limoges, 87022, France

Location

Centre Léon Bérard, Département de Cancérologie Médicale

Lyon, 69373, France

Location

Hôpital Européen, Service d'Oncologie

Marseille, 13003, France

Location

Centre Hospitalier Universitaire de Montpellier - Hôpital St Eloi

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Poitiers, Hôpital la Milétrie

Poitiers, 86021, France

Location

Institut de Cancérologie de la Loire Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Centre Hospitalier de Thonon Hôpitaux du Léman, site Georges Pianta Service de Gynécologie Obstétrique

Thonon-les-Bains, 74203, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

MATHEVET, MD

CONTACT

795 567 520; Patrice.Mathevet@chuv.ch

FEBVEY-COMBES, MD

CONTACT

472 115 162; olivia.febvey-combes@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2021
• First Posted: May 24, 2021
• Study Start: May 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: December 31, 2021
• Last Updated: May 24, 2021

Record last verified: 2021-05

Locations

FR (11)