EPIK-B3 - Clinical trial • Breast Cancer Foundation NZ

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EPIK-B3

Advanced Breast Cancer clinical trials for Triple negative

Recruiting
Updated: July 6, 2020

This study will determine whether treatment with alpelisib in combination with abraxane is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation or have PTEN loss without PIK3CA mutation.

The purpose of this study is to determine whether treatment with alpelisib in combination with abraxane is safe and effective in subjects with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation (Study Part A) or have PTEN loss without PIK3CA mutation (Study Parts B1 and B2)

Who is it for?

You may be eligible for this study if you meet the below criteria:

  • Subject has histologically confirmed diagnosis of advanced (loco-regionally recurrent and not amenable to curative therapy, or metastatic (stage IV)) TNBC.
  • Subject has either a measurable disease per RECIST 1.1 criteria or, if no measurable disease is present, then at least one predominantly lytic bone lesion or mixed lytic-blastic bone lesion with identifiable soft tissue component (that can be evaluated by CT/MRI) must be present Part B1: patients must have measurable disease.
  • Subject has adequate tumor tissue to identify the PIK3CA mutation status (either carrying a mutation or without a mutation) and the PTEN loss status; both of which will determine whether the subject can be allocated to Part A - PIK3CA mutation regardless of PTEN status; or to Part B - PTEN loss without a PIK3CA mutation.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Subject has received no more than one line of therapy for metastatic disease.
  • Subject has adequate bone marrow and organ function.

Study details

Alpelisib + abraxane: Drug: Patients will be administered 300mg alpelisib orally once per day and 100 mg/m² abraxane as IV infusion on Days 1, 8 and 15 of a 28-day cycle.

Placebo + abraxane: Drug: Patients will be administered 300mg placebo orally once per day and 100 mg/m² abraxane as IV infusion on Days 1, 8 and 15 of a 28-day cycle.

For full trial information

Australia

Nedlands

Contact:

Novartis Pharmaceuticals

If you think you might be a candidate for this trial, use the contact details supplied, or talk to your doctor.

Want to access a trial that's not in your area? It's not always possible, but if you're interested, email us at intouch@bcf.org.nz

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