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RecruitingLast updated: 2 December 2022

IPATunity150: This phase Ib/III trial is examining the effectiveness and safety of using a novel targeted therapy (Ipatasertib) in combination with another targeted therapy (Palbociclib) and chemotherapy (Fulvestrant) to treat advanced unresectable or metastatic breast cancerA phase Ib/III study of Ipatasertib plus Palbociclib and Fulvestrant versus placebo plus Palbociclib and Fulvestrant in hormone receptor positive and HER2 negative locally advanced unresectable or metastatic breast cancer

Clinical summary

Summary

This trial will consist of two parts: a phase Ib section and a phase III section. Eligible patients in the phase Ib section will receive single oral daily doses of Ipatasertib for a run-in period of 5-7 days, and then for Day 1-21 of the first 28-day cycle. Doses will increase to twice per day for Day 1-21 in the second cycle. Palbociclib and Fulvestrant will also be received during the phase Ib part, as per the details below. During the phase III part eligible patients will receive either Ipatasertib or a placebo to be orally administered once per day on Days 1-21 of each 28 day cycle, at the dose identified in the part Ib phase. Patients will also receive Palbociclib to be orally administered once per day on Days 1-21 of each 28-day cycle and injections of Fulvestrant on Day 1 and 15 of the first cycle and Day 1 for all other cycles.

Conditions

This trial is treating patients with locally advanced inoperable or metastatic breast cancer.

Cancer

Breast Cancers Breast

Age

People18+

Phase

III

Trial Acronym

IPATunity150

More information

Trial Identifiers

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Commercial Sponsor

Hoffmann-La Roche

Scientific Title

A phase Ib/III study of Ipatasertib plus Palbociclib and Fulvestrant versus placebo plus Palbociclib and Fulvestrant in hormone receptor positive and HER2 negative locally advanced unresectable or metastatic breast cancer

Eligibility

Inclusion

  • You are able to swallow medication by mouth.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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