Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

CAPTURE : A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast

Trial Overview Read MoreRead more

This phase II trial is trying to find out if treatment with a targeted cancer therapy (alpelisib) and a chemotherapy (fulvestrant) increases survival compared to a chemotherapy (capecitabine) alone in men and women with ER+, HER2- breast cancer with a PIKC3A mutation.
 

This trial is treating patients with ER+, 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 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.
  • You have previously been treated (or are currently being treated) on a clinical trial.

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

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A phase II randomised study to evaluate alpelisib plus fulvestrant versus capecitabine in oestrogen receptor positive, HER2-negative advanced breast cancer patients with PIK3CA mutant circulating DNA

Other Non-Commercial Sponsor

National Health & Medical Research Council (NHMRC)

Summary

Eligible patients will be randomised 1:1 to either: Arm A: alpelisib plus fulvestrant (clinic visits every 28 days) OR Arm B: capecitabine (clinic visits every 21 days).

Recruiting Hospitals Read MoreRead more

Ballarat Hospital
Ballarat
Ms Carmel Goss
CarmelG@bhs.org.au
03 5320 4735

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

Box Hill Hospital Medical Oncology
Box Hill
Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Epworth Freemasons, Medical Oncology
East Melbourne
Ms Jenni Flynn
jenni.flynn@epworth.org.au
03 9936 8206

Maroondah Hospital, Maroondah Breast Clinic
Ringwood East
Ms Lauren Mitchell
lauren.mitchell@monash.edu
03 9094 9544

Monash Health, Medical Oncology
Clayton
Breast and Gynaecology Research Study Coordinator
breastgynae.oncresearch@monashhealth.org
0491299561

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Enquiries Line Coordinator
clinicaltrials.enquiries@petermac.org
03 8559 7456 (9am-2pm, Mon-Fri)

South West Healthcare
Warrnambool
Kaye McDowall
swhct@swh.net.au

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.

Next