NEOZOL_Follow-up Study (NEOZOL_FU)

May 21, 2021 updated by: Hospices Civils de Lyon

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

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®).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bourg-en-Bresse, France, 01012
        • Centre hospitalier de Bourg en Bresse, Hôpital Fleyriat, Service d'Onco-Hématologie et de Gynécologie Obstétrique
        • Contact:
        • Contact:
      • Bron, France, 69677
        • Hôpital Femme Mère Enfant, Groupement Hospitalier EST, Service de Gynécologie Clinique
        • Contact:
      • Clermont-Ferrand, France, 63011
        • Centre de Lutte Contre le Cancer - Institut Jean Perrin, Service de Médecine Oncologique
        • Contact:
      • Contamine-sur-Arve, France, 74130
        • Centre Hospitalier Alpes Léman, Service de Gynécologie
        • Contact:
      • Limoges, France, 87022
        • Centre Hospitalier Universitaire de Limoges, Hôpital Dupuytren 1, Service d'Oncologie Médicale,
        • Contact:
      • Lyon, France, 69373
      • Marseille, France, 13003
      • Montpellier, France, 34295
      • Poitiers, France, 86021
      • Saint-Priest-en-Jarez, France, 42270
        • Institut de Cancérologie de la Loire Lucien Neuwirth
        • Contact:
          • CHAULEUR, MD
          • Phone Number: +33 477 917 000
        • Contact:
      • Thonon-les-Bains, France, 74203
        • Centre Hospitalier de Thonon Hôpitaux du Léman, site Georges Pianta Service de Gynécologie Obstétrique
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.
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
To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 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.
31/12/2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

May 1, 2021

Primary Completion (Anticipated)

October 30, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

May 21, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 24, 2021

Last Update Submitted That Met QC Criteria

May 21, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0552

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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