NEOZOL_Follow-up Study

Study Overview
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Brief Summary
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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®).

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

Conditions
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Locally Advanced Breast Cancer

Intervention / Treatment
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* Other: Survival survey


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group (neo-adjuvant chemotherapy combined with ZOMETA®) (zoledronic acid)<br>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<br>* To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.<br>|
| Control group (neo-adjuvant chemotherapy alone)<br>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<br>* To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Zometa®, Survival survey, Neoadjuvant chemotherapy