Hormone receptor (HR)-positive/HER2-negative locally advanced unresectable or metastatic breast cancer MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864 MedDRA version: 20.0 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: ipatasertib 100 mg
Product Code: RO5532961
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: IPATASERTIB
Current Sponsor code: RO5532961
Concentration unit: mg milligram(s)
Co
Sponsors
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age >= 18 years - 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 a condom, 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 170
Exclusion criteria
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 Ib only: Prior treatment with CDK4/6 inhibitor - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in the intent to treat (ITT) population and in patients with PIK3CA/AKT1/PTEN altered tumors (Phase III);Secondary Objective: 1. To evaluate additional efficacy of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in the ITT population and in patients with PIK3CA/AKT1/PTEN altered tumors (Phase III) 2. To characterize the safety of combining ipatasertib with palbociclib + fulvestrant (Phase Ib and III) 3. To characterize the Pharmacokinetic profiles of ipatasertib and its metabolite (G-037720) in combination with palbociclib and fulvestrant (Phase Ib and III);Primary end point(s): 1. Progression-free survival (PFS) in ITT patients 2. PFS in patients with PIK3CA/AKT1/PTEN altered Tumors;Timepoint(s) of evaluation of this end point: Phase III 1-2. Up to 64 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Phase III 1. Objective response rate (ORR) 2. Duration of objective response (DOR) 3. Clinical benefit rate (CBR) 4. Overall survival (OS) 5. Time to deterioration (TTD) in pain 6. TTD in physical functioning, role functioning, and Global Health Survey/Health-Related Quality of Life Phase Ib and III 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 8. Change from baseline in targeted vital signs 9. Change from baseline in targeted clinical laboratory test results 10. Plasma concentration of ipatasertib and its metabolite, G-037720, at specified timepoints;Timepoint(s) of evaluation of this end point: 1-9. Up to 64 months 10. Phase Ib: Cycle 1 Day 1 and 15; Cycle 2 and 3 Day 15; Phase III: Cycle 1 Day 1 and 15; Cycle 2 Day 15 | — |
Countries
Australia, Brazil, Canada, Japan, Korea, Republic of, Spain, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed