LIME - Clinical trial • Breast Cancer Foundation NZ

LIME

Early Breast Cancer clinical trials for ER+

Recruiting
Updated: January 20, 2022

This is an observational study of the frequency and causes of impaired liver metabolism of cyclophosphamide in breast cancer.

This is an observational study of the frequency and causes of impaired liver metabolism of cyclophosphamide in breast cancer.

Key inclusion criteria

  • Age>18
  • ECOG (Eastern Cooperative Oncology Group) Performance Status 0-2
  • Histologically confirmed breast cancer
  • To receive intravenous cyclophosphamide as part of adjuvant, neoadjuvant or first line chemotherapy for breast cancer as part of standard care.
  • Staging investigations in process (should not be greater than 2 weeks after start of chemotherapy).
  • Patients must be able to provide written informed consent
  • Aspartate transaminase (AST), Alaninine transaminase (ALT) =< 2.5 X upper limit of normal (ULN) for institution
  • Alkaline phosphatase <5x ULN
  • Bilirubin =< ULN, except when due to Gilbert’s Disease
  • Creatinine <1.5 ULN

Key exclusion criteria

  • Patients receiving medication which is either a CYP2C19 inhibitor or inducer, and where a washout period of 5 days is not clinically feasible
  • Chronic inflammatory condition such as systemic lupus erythematosis, inflammatory bowel disease, other autoimmune phenomenon or active chronic infection
  • Active infections (e.g. wound) at time of chemotherapy
  • Pregnant or breast feeding
  • Other active malignancy within the last 5 years, excluding non-melanoma skin cancers, or preinvasive cervical cancer that has been treated definitively

    Full trial information

    New Zealand

    Auckland

    Contact:

    Nuala Helsby

    If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

    Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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