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NCT Number: NCT00525759

Investigating the Biological Effects of the Addition of Zoledronic Acid to Pre-operative Chemotherapy in Breast Cancer

There is clear preclinical in vitro and in vivo evidence of sequence dependent synergy between chemotherapy agents and zoledronic acid. The aim of the study is to investigate if the synergistic increase in tumour cell apoptosis observed in preclinical studies occurs in patients. The hypothesis for this study is that there may be anti-tumour benefits of the sequential application of chemotherapy agents followed by zoledronic acid in patients with invasive breast cancer.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Sheffield Teaching Hospitals NHS Foundation Trust / Weston Park Hospital

Sheffield, South Yorkshire, S10 2SJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with histological diagnosis of invasive breast cancer requiring neoadjuvant chemotherapy
  • T2 tumour or above
  • WHO Performance status of 0,1 or 2
  • Must consent to or have undergone a core biopsy for diagnosis of breast cancer AND consent to undergo an additional core biopsy prior to the second cycle of chemotherapy (Day 5 +/- Day 21)
  • Written informed consent

Exclusion criteria

  • Previous chemotherapy or radiotherapy to treated breast
  • Evidence of metastatic disease or recurrent breast cancer or previous malignancy (some exceptions)
  • Calculated creatinine clearance < 40mls/min
  • Prior treatment with bisphosphonates in last year or known contraindications to bisphosphonate therapy
  • Concurrent tamoxifen or aromatase inhibitor medication
  • Pregnant or lactating women
  • Cardiac dysfunction that precludes use of anthracycline chemotherapy
  • Unwilling to have extra interim biopsy

Treatment and study plan

5-FU, Epirubicin, Cyclophosphamide, Docetaxel

Drug

3 cycles of FEC q3w, followed by 3 cycles of docetaxel q3w FEC: 5FU 500mg/m2 intravenous bolus D1, Epirubicin 100mg/m2 intravenous bolus D1, Cyclophosphamide 500mg/m2 intravenous bolus D1) every 21 days Docetaxel: (100mg/ m2 intravenous infusion) every 21 days

5-FU, Epirubicin, Cyclophosphamide, Docetaxel, Zoledronic acid

Drug

3 cycles of FEC q3w, followed by 3 cycles of docetaxel q3w FEC: 5FU 500mg/m2 intravenous bolus D1, Epirubicin 100mg/m2 intravenous bolus D1, Cyclophosphamide 500mg/m2 intravenous bolus D1) every 21 days Docetaxel: (100mg/ m2 intravenous infusion) every 21 days Zoledronic acid: 4mg intravenous infusion Day 2, AFTER FIRST CYCLE CHEMOTHERAPY ONLY

Primary outcomes

  1. Increase in apoptotic index between diagnostic core biopsy and repeat core biopsy taken on day 5

    Time frame: Repeat biopsy on day 5 (+/- day 21)

Secondary outcomes

  1. Reduction in Ki67 immunostaining between preoperative core biopsy, repeat core biopsy on day 5, +/- day 21, and operative specimen

    Time frame: Day 5, +/- Day 21, surgical specimen

  2. Changes in serum angiogenesis markers between pre-treatment and operative time points

    Time frame: Pre-treatment, Day 5, day 21, pre-surgery

  3. Changes in bone biochemical markers between pre-treatment, treatment and operative timepoints

    Time frame: Pre-treatment, Day 5, day 21, pre-surgery

  4. Detection of, and changes in, circulating tumour cells in peripheral blood taken pre-treatment, during treatment and following treatment

    Time frame: Pre-treatment, day 5, day 21, pre-surgery

Sponsors and collaborators

Lead sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Other

Collaborators

  • University of Sheffield

Registry information

Official study title

A Randomised Phase II Feasibility Study Investigating the Biological Effects of the Addition of Zoledronic Acid to Neoadjuvant Combination Chemotherapy on Invasive Breast Cancer

Acronym: ANZAC

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Sep 6, 2007
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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