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ClinicalTrials.gov ID

NCT04899713

Lead Sponsor

Hospices Civils de LyonOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

50Estimated

Last Update Posted

May 24, 2021Actual

Start Date

May 2021Estimated

Primary Completion Date

Oct 30, 2021Estimated

Completion Date

Dec 31, 2021Estimated

Official Title

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

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®).

• Locally Advanced Breast Cancer

• Survival survey

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Retrospective

Lead Sponsor

Hospices Civils de LyonOTHER

philippedalivoust@gmail.com491 833 838 ext. +33