Trial ID:NCT04060862
Protocol #:19-602
Condition(s):Breast Cancer
Phase:III
Principal Investigator:Wander, Seth, A
Site Investigator(s):Mayer, Erica, L.
Site Research Nurse(s):Bychkovsky, Brittany,
Campbell, Margaret,
Caradonna, Lisa,
Hershey, Allie,
Kasparian, Elizabeth,
Roche, Kathleen, A.
Rutter, Morgan,
Trial Description:
The open-label Phase Ib portion of 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.
Eligibility Requirements:
- 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
Exclusion Criteria:
- Pregnant or breastfeeding, or intending to become pregnant
- Prior treatment with fulvestrant or other selective estrogen receptor down-regulator
- Prior treatment with PI3K inhibitor, mTOR inhibitor or AKT inhibitor
- Phase III only: Prior treatment with CDK4/6 inhibitor for locally advanced
unresectable or metastatic breast cancer
- Prior treatment with a cytotoxic chemotherapy regimen for metastatic breast cancer
- History of Type I or Type II diabetes mellitus requiring insulin
- History of or active inflammatory bowel disease or active bowel inflammation
- Lung disease: pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis,
cystic fibrosis, Aspergillosis, active tuberculosis, or history of opportunistic
infections
Protocol #: 19-602