CAPItello-291 : A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-130Age 18-130

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy,Treatment | BreastBreast

Trial Overview Read MoreRead more

This phase III trial is trying to understand whether it is more or less effective to use hormone therapy alone or in combination with a targeted cancer drug for the treatment of advanced HR+/HER2- breast cancer that has gotten worse or come back on prior treatment.
 

This trial is treating patients with HR+/HER2- breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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Scientific Title

A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Breast Cancer Following Recurrence or Progression On or After Treatment With an Aromatase Inhibitor

Commercial Sponsor

AstraZeneca

Summary

Eligible patients will be randomised to receive 2 intramuscular injections of Fulvestrant in combination with 400 mg capivasertib (2 oral tablets) or a placebo-equivalent twice daily on intermittent weeks.

Recruiting Hospitals Read MoreRead more

Border Medical Oncology
Albury
Ms Nyree Sarakis
Nsarkis@bordermedonc.com.au
02 6064 1493

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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