A 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
TerminatedPhase 1Results postedLast updated 8 November 2024
What this trial tests
Phase 1 trial testing Ipatasertib in Breast Cancer in 20 participants. Terminated before completion.
18 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase Ib: Number of Participants With Adverse Events and Adverse Events With Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)Secondary· Up to 36 Months
AE=any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. Severity of AEs were rated per NCI CTCAE v5 where, Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; di
Any AE: Any Grade
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
20
Grade 1
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
3
Grade 2
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
3
Grade 3
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
12
Grade 4
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
5
Phase Ib: Plasma Concentration of Ipatasertib and Its Metabolite G-037720Secondary· Cycle 1, Day 1 and 15: 0.25 hours pre-dose, 0.5, 1, 2, 3, 4 and 6 hours post- dose ; Cycle 2, Day 15: 0.25 hours pre-dose; Cycle 3, Day 15: 0.15 hours pre-dose, 2 hours post-dose (each cycle = 28 days)
Plasma concentrations of Ipatasertib and its metabolite G-037720 are reported.
Ipatasertib: Cycle 1 Day 15 0.25 hours pre-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
46.6
± 56.0
Ipatasertib: Cycle 1 Day 15 0.5-hours post-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
150
± 112.3
Ipatasertib: Cycle 1 Day 15 1-hours post-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
236
± 83.4
Ipatasertib: Cycle 1 Day 15 2-hours post-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
299
± 68.0
Ipatasertib: Cycle 1 Day 15 3-hours post-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
290
± 34.2
Ipatasertib: Cycle 1 Day 15 4-hours post-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
244
± 30.2
Ipatasertib: Cycle 1 Day 15 6-hours post-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
192
± 40.1
Ipatasertib: Cycle 2 Day 15 0.25 hours pre-dose
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
42.8
± 46.4
Phase Ib: Maximum Concentration (Cmax) of Ipatasertib and Its Metabolite G-037720 in PlasmaSecondary· Cycle 1: Day 1 and Day 15
Cmax of ipatasertib and its metabolite G-037720 in plasma is reported.
Ipatasertib: Cycle 1 Day 1
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
294
± 52.6
Ipatasertib: Cycle 1 Day 15
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
437
± 41.1
G-037720: Cycle 1 Day 1
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
120
± 84.2
G-037720: Cycle 1 Day 15
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
137
± 53.4
Phase Ib: Area Under the Plasma Concentration Time-curve From Zero to 24 Hours (AUC0-24) of Ipatasertib and Its Metabolite G-037720Secondary· Cycle 1: Day 1 and Day 15
AUC0-24 of Ipatasertib and its metabolite G-037720 is reported
Ipatasertb: Cycle 1 Day 1
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
2169.88
± 46.3
Ipatasertb: Cycle 1 Day 15
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
3636.97
± 33.7
G-037720: Cycle 1 Day 1
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
1157.02
± 76.6
G-037720: Cycle 1 Day 15
Group
Value
95% CI
Phase 1b: Ipatasertib + Palbociclib +Fulvestrant
1391.60
± 44.9
Phase Ib: Time to Maximum Concentration (Tmax) of Ipatasertib and Its Metabolite G-037720Secondary· Cycle 1: Day 1 and Day 15
Tmax of ipatasertib and its metabolite G-037720 isreported.
Ipatasertib: Cycle 1 Day 1
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
1.00
0.50 – 4.00
Ipatasertib: Cycle 1 Day 15
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
1.92
0.50 – 4.00
G-037720: Cycle 1 Day 1
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
2.00
0.97 – 4.00
G-037720: Cycle 1 Day 15
Group
Value
95% CI
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
2.00
1.00 – 3.08
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 36 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Phase Ib: Ipatasertib + Palbociclib +Fulvestrant
Serious: 4/20 (20%)
Deaths: 0/20
Serious adverse events (4 terms)
Reaction
System
Phase Ib: Ipatasertib + Pa…
Neutropenia
Blood and lymphatic system disorders
—
Pseudomembranous colitis
Infections and infestations
—
Soft tissue infection
Infections and infestations
—
Bone pain
Musculoskeletal and connective tissue disorders
—
Other adverse events (116 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT05554380 — Study of Chemotherapy Plus Ipatasertib for People With Solid Tumors With PTEN/AKT Mutations, A ComboMATCH Treatment Tria
· Phase 2
· suspended
NCT05862285 — A Rollover Study for Participants Previously Enrolled in a Genentech and/or F. Hoffman-La Roche Sponsored Study
· Phase 3
· recruiting
NCT05564377 — Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The Co
· Phase 2
· recruiting
NCT05538897 — Testing the Addition of the AKT Inhibitor, Ipatasertib, to Treatment With the Hormonal Agent Megestrol Acetate for Recur
· Phase 1, PHASE2
· active not recruiting
NCT05172245 — Testing the Addition of Ipatasertib to Usual Chemotherapy and Radiation for Head and Neck Cancer
· Phase 1
· recruiting
Other recruiting trials for Breast Cancer
Currently open trials in the same condition.
NCT06148038 — CBD for Breast Cancer Primary Tumors
· Phase 1
· recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R
· Phase 2
· recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
· Phase 2
· recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
· NA
· recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer
· Phase 2
· recruiting
Other Hoffmann-La Roche trials
Trials by the same sponsor.
NCT07503340 — A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous O
· Phase 2
· not yet recruiting
NCT07298421 — A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in
· Phase 3
· recruiting
NCT07059273 — A COPD Data Registry for Participants With Frequent Exacerbations
· not yet recruiting
NCT07416526 — A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
· Phase 3
· recruiting
NCT05199688 — A Study To Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, And Pharmacodynamics Of Satralizumab In Pediatric
· Phase 3
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hoffmann-La Roche
Last refreshed: 8 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04060862.