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Fulvestrant +/- Akt Inhibition in Advanced Aromatase Inhibitor Resistant Breast Cancer

NCT01992952 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2025-11-26

No results posted yet for this study

Summary

This is a two stage study, with an initial dose escalation phase I study and subsequent double blind randomised phase II controlled trial. Eligible patients are post-menopausal women with metastatic ER+ breast cancer not suitable for surgical resection. Patients should be suitable for endocrine treatment, but have received no more than 3 previous lines of endocrine treatment and up to 1 line of chemotherapy for metastatic disease. They will also have had progressive disease during treatment with an aromatase inhibitor. Following the dose-escalation in stage 1, patients will be randomised to receive fulvestrant plus either placebo or 480mg (or maximum tolerated dose) of AZD5363 oral capsules or tablets taken once daily.

Patients will receive fulvestrant in combination with either placebo or AZD5363 until disease progression. Patients may continue to receive fulvestrant and AZD5363/placebo treatment even after the last trial visit.

Conditions

  • Estrogen Receptor Positive Breast Cancer

Interventions

DRUG

AZD5363

Up to 480mg oral tablets twice a day, taken four days on, 3 days off treatment.

DRUG

Placebo

Placebo tablets taken twice a day, 4 days on treatment, 3 days off treatment

DRUG

Fulvestrant

2 x 250mg injections, received on Days 1 and 15 of cycle 1, and on day 1 of each subsequent 28 day cycle.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Cenduit LLC

    collaborator INDUSTRY

  • Covance

    collaborator INDUSTRY

  • Cardiff and Vale University Health Board

    collaborator OTHER_GOV

  • Velindre NHS Trust

    lead OTHER_GOV

Principal Investigators

  • Sacha Howell, FRCP PhD · The University of Manchester and The Christie NHS Foundation Trust

  • Robert Jones, MRCP PhD · Cardiff University and Velindre Cancer Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-07
Primary Completion
2019-03-31
Completion
2025-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
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 NCT01992952 on ClinicalTrials.gov