32 Participants NeededMy employer runs this trial

Sapanisertib + Serabelisib for Breast Cancer

Recruiting at 2 trial locations
MM
Overseen ByMedical Monitor
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants with HR+/HER2- advanced/metastatic breast cancer.

Are You a Good Fit for This Trial?

Inclusion Criteria

My breast cancer is HR positive and HER2 negative.
My cancer is advanced or has come back and cannot be cured with surgery or radiation.
I am fully active or have only minor limitations in daily activities.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies

6 months
Regular visits for dose escalation and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months
Periodic visits for safety and efficacy assessments

Long-term follow-up

Participants are monitored for progression-free survival and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Sapanisertib
  • Serabelisib

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Cohort A2 - Sapanisertib and serabelisib (PIKTOR) with fulvestrantExperimental Treatment3 Interventions
Group II: Cohort A1 - Sapanisertib and serabelisib (PIKTOR) with fulvestrantExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Faeth Therapeutics

Lead Sponsor

Trials
4
Recruited
170+