WO41554-INAVO120

The purpose of this study is to compare the effects, good or bad of an investigational product, inavolisib, when combined with palbociclib and fulvestrant. In this study, you will get either inavolisib or placebo and no one (you, your doctors, or the company sponsoring this study) will know who is receiving inavolisib and who is receiving placebo. This helps to ensure that the results are free from bias.

Category
Trial Status
Recruiting
Trial Phase
Phase 3 Drug Trial
Registry Listing
ERM Project ID
58288
Trial contact details
Contact Person
Caitlin Bennett
What you need to know

Who can take part?

Patients with breast cancer which is hormone receptor positive and  HER2-negative  that has progressed, or spread shortly after completing endocrine therapy.

What is involved for you?

You will  receive the approved standard treatment for your cancer, a targeted therapy (palbociclib) in combination with an endocrine therapy (fulvestrant), and well as the inavolisib or placebo. Inavolisib is a tablet taken by mouth each day. Fulvestrant is a monthly injection and palbociclib is a tablet taken by mouth once a day for 21 days and then not taken for 7 days. It will involve seeing the doctor and coordinator for study visits every month  for physical exams, ECG's, blood tests, tumour assessments (ie-CT scans).

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