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A Study to Assess the Ability of a Novel Endocrine Treatment for Breast Cancer, Irosustat, to Slow Down Cancer Growth

NCT01662726 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2016-03-14

No results posted yet for this study

Summary

This study is investigating the effects of a new hormone treatment for breast cancer called Irosustat. Seventy percent of breast cancers in post-menopausal wome rely on oestrogen to grow therefore are likely to respond to hormone therapy. Irosustat blocks a different pathway of steroid synthesis to Aromatase, reducing in this way oestrogen levels in the body. As less oestrogen reaches the breast cancer, it grows more slowly or stops growing altogether.

IPET will recruit postmenopausal women with early, hormone sensitive, treatment naive breast cancer will receive 40mg of Irosustat once daily for 2 weeks. The effects of Irosustat on breast cancer will be evaluated by PET scans (Positron Emission Tomography) using a radioactive substance called FLT as a tracer. The scans will be performed in a PET-CT scanner which combines a PET scan and a CT scan (Computer Tomography) into one scan. This type of scan can show how body tissues are working, as well as what they look like. FLT-PET scans will be performed before and following treatment with Irosustat. As cancer cells grow faster than the normal cells around them, they will take up more of the radioactive substance, and so stand out clearly on the scan. If Irosustat is slowing down the cancer growth, the cancer will take up less of the tracer.

Blood samples will be taken at regular intervals to assess what the new drug does to the body and the safety and tolerability of Irosustat will be assessed. The study incorporates translation aspects/endpoints which are based on the collection of tumour biopsies before and after treatment with Irosustat although the later biopsy is not mandatory.

Conditions

  • Breast Neoplasms

Interventions

DRUG

Irosustat

Irosustat will be administered once daily in 40mg tablets. Treatment will start the day after the baseline FLT-PET and will be continued for a minimum of 2 weeks until the follow up FLT PET scan. For those patients who have consented to a repeat tumour biopsy, treatment will be extended to the day before the procedure. Study medication should be taken in the morning under fasting conditions with a glass of water, 30 minutes before breakfast.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Ipsen

    collaborator INDUSTRY

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER

  • University of Southern California

    collaborator OTHER

  • QPS Netherlands B.V.

    collaborator INDUSTRY

  • Imperial College London

    lead OTHER

Principal Investigators

  • Carlo Palmieri, BSc MBBS PhD · Imperial Colllge London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2014-07-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01662726 on ClinicalTrials.gov