Data

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 (BCT 1901 CAPTURE)

Breast Cancer Trials (BCT)

Dataset description

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 66 participants with oestrogen receptor positive, HER2 negative advanced breast cancer and PIK3CA mutant circulating DNA who are randomised to evaluate treatment with alpelisib plus fulvestrant compared with capecitabine on progression free survival. The experimental arm is alpelisib at a dose of 300 mg administered by oral tablet once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in combination with fulvestrant 500 mg intramuscular every 28 days. The comparator arm is capecitabine at a dose of 1000 mg/m^2 administered by oral tablet twice daily on Day 1 to 14 of a 21 day cycle. the primary endpoint is progression free survival (PFS) measured as per RECIST 1.1.
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Subjects

Chemotherapy |

Source Study

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Prof Sarah-Jane Dawson

Brief Summary

This study aims to find out whether treatment with alpelisib plus fulvestrant increases progression-free survival compared to capecitabine in women and men with eostrogen receptor positive (ER+), HER2-negative advanced breast cancer who have a PIKC3A mutation identified in circulating tumour DNA (ctDNA). Who is it for? This study may be suitable for you if you are 18 years or older, have advanced ER+, HER2-negative breast cancer, and have already had treatment with a CDK4/6 inhibitor and an arom ....
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Key Inclusion Criteria

PRE-SCREENING For inclusion in the pre-screening, participants must fulfil all the following criteria: 1. Female or Male, >= 18 years. 2. Advanced (locoregionally recurrent not amenable to curative therapy, or metastatic) ER-positive, HER2-negative breast cancer, histologically defined as: a. ER positive: Locally assessed oestrogen receptor status based on assessment of primary or metastatic disease. ER-positive is defined as >=10% (any PR expression) by immunohistochemistry irrespective of stai ....
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Key Exclusion Criteria

1. Any disease burden that makes participants ineligible for endocrine therapy as per the investigator’s best judgement. 2. Prior treatment with capecitabine, fulvestrant, any PI3K, mTOR or AKT inhibitor. 3. Known hypersensitivity or contra-indication to alpelisib, fulvestrant or capecitabine. 4. Concurrently using other anti-cancer therapy. Exception: goserelin. 5. Previous or concomitant invasive malignancy. The exceptions are: a. participants with non-breast malignancy >= 3 years ago, treated ....
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Can healthy volunteers participate?

No

 

Population

Sample Size    66

Min. age    18 Years

Max. age    No limit

Sex    Both males and females

Condition category    Advanced Breast Cancer

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs

Alpelisib at a dose of 300 mg will be administered by oral tablet once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in combination with fulvestrant 500 mg intramuscular every 28 days. Pre- or peri-menopausal women will also receive a 3.6 mg goserelin implant under the skin every 28 days. Participants will be given a patient diary to monitor their alpelisib administration; the diary will be checked at each treatment visit. Treatment will continue until one of the following crit ....
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Comparison

Control group Active

Capecitabine at a dose of 1000 mg/m^2 will be administered by oral tablet twice daily on Day 1 to 14 of a 21 day cycle. Participants will be given a patient diary to monitor their capecitabine administration; the diary will be checked at each treatment visit. Treatment will continue until one of the following criteria applies: * Documented disease progression#; * Intercurrent illness that prevents further administration of treatment; * Unacceptable adverse event(s) or toxicity; * Withdrawal of c ....
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Outcomes

Outcome: Progression Free Survival (PFS) measured as per RECIST 1.1
Timepoint: The duration of time from randomisation until the date of progression or death from any cause.

Study Protocol: Not Available
Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

Anonymised Individual Patient Data (IPD) collected during the trial.

When will data be available?

Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines.

Available to whom?

Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines.

Available for what types of analyses?

To achieve the aims in the approved proposal.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au