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AZD4547 & Anastrozole or Letrozole (NSAIs) in ER+ Breast Cancer Patients Who Have Progressed on NSAIs (RADICAL)

NCT01791985 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2022-08-22

Study results available
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Summary

This study is looking at a new drug called AZD4547 which is being tested for the treatment of oestrogen receptor positive breast cancer. AZD4547 is a drug which specifically "blocks" proteins called fibroblast growth factor receptors (FGFR1) that are involved in the processes that help cancer cells to grow. These proteins may also be responsible for the development of resistance to hormonal therapies used to treat some breast cancers. AZD4547 is not yet approved for use in breast cancer and is therefore being used in this study as a research drug.

The investigators will also test the theory that it is not necessary for high levels of FGFR1 to be present in the body to see benefit from AZD4547. (Stage 1 only)

Conditions

Interventions

DRUG

AZD4547 / anastrozole or letrozole

Patients will continue or restart the NSAI which they have progressed\* on: either anastrozole (1mg) or letrozole (2.5mg), orally, once daily but together with twice daily AZD4547 (80mg). AZD4547 will be given on an intermittent schedule of one week on / one week off. \*Prior to study entry, patients must have taken anastrozole or letrozole at some stage in their treatment to date for breast cancer; and shown evidence of resistance to this therapy. The NSAI does not have to be the most recent line of treatment.

Sponsors & Collaborators

Principal Investigators

  • Michael Seckl · Imperial College Healthcare NHS Trust

  • Nicola Cresti · Newcastle-upon-Tyne Hospitals NHS Trust

  • Richard Baird · Cambridge University Hospitals NHS Foundation Trust

  • Iain MacPherson · NHS Greater Glasgow and Clyde

  • Amitabha Chakrabarti · Poole Hospital NHS Foundation Trust

  • Mojca Persic · Burton Hospitals NHS Foundation Trust

  • Anne Armstrong · The Christie NHS Foundation Trust

  • Rozenn Allerton · The Dudley Group NHS Foundation Trust

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2016-11-30
Completion
2018-12-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
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 NCT01791985 on ClinicalTrials.gov