IPATunity150 - Clinical trial • Breast Cancer Foundation NZ

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IPATunity150

Advanced Breast Cancer clinical trials for ER+

Recruiting
Updated: July 6, 2020

This study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of
ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion.

The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.

Who is it for?

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

  • HR+ HER2- adenocarcinoma of the breast that is locally advanced unresectable or metastatic.
  • For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs.
  • For men: agreement to remain abstinent or use contraceptive methods, and agreement to refrain from donating sperm.
  • Radiologic/objective relapse during adjuvant endocrine therapy or disease progression during the initial 12 months of 1L endocrine therapy in locally advanced unresectable or metastatic breast cancer.
  • At least one measurable lesion via Response Evaluation Criteria in Solid Tumors, Version 1.1.
  • Phase III only: Tumor specimen from the most recently collected, available tumor tissue.

Study details

Ipatasertib + palbociclib + fulvestrant: Patients will receive 300mg ipatasertib orally once daily during an initial 5-7 day run-in period, then continued on Days 1-21 during the first cycle. Starting with Cycle 2, Day 1 ipatasertib will be taken orally once daily on Days 1-21 of each 28-day cycle. Palbociclib will be administered orally on Days 1-21 of each 28-day cycle. 500mg fulvestrant will be administered as two intramuscular injections of 250mg each on Cycle 1 Days 1 and 15 and Day 1 of each subsequent 28-day cycle.

Placebo + palbociclib + fulvestrant: Patients will receive 300mg placebo orally once daily on Days 1-21 on each 28-day cycle. Palbociclib will be administered orally on Days 1-21 of each 28-day cycle. 500mg fulvestrant will be administered as two intramuscular injections of 250mg each on Cycle 1 Days 1 and 15 and Day 1 of each subsequent 28-day cycle.

For full trial information

Australia

Cabrini Medical Centre; Oncology, Malvern

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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