NCT04899713

NEOZOL_Follow-up Study

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
OTHER	Survival survey	To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.

Timeline

• Start date: 2021-05-01
• Primary completion: 2021-10-30
• Completion: 2021-12-31
• First posted: 2021-05-24
• Last updated: 2021-05-24

Locations

11 sites across 1 country: France