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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Repeat biopsy on day 5 (+/- day 21)

Safety Issue:

No

Principal Investigator

Robert E Coleman, MB BS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Academic Unit of Clinical Oncology, University of Sheffield

Authority:

United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:

STH14707

NCT ID:

NCT00525759

Start Date:

July 2007

Completion Date:

January 2010

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Zoledronic acid
  • Neoadjuvant chemotherapy
  • Synergy
  • Apoptosis
  • Breast Neoplasms

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