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PD-L1 Inhibitor

Ipatasertib for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 49 months
Awards & highlights

Study Summary

This trial will study whether adding ipatasertib to atezolizumab and paclitaxel helps people with TNBC that hasn't been treated before.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 49 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 49 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall Survival (OS)
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
Secondary outcome measures
Number of Participants With Adverse Events (AEs)
Other outcome measures
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Duration of Response (DOR) for participants with PIK3CA/AKT1/PTEN-altered tumors
+12 more

Side effects data

From 2023 Phase 3 trial • 242 Patients • NCT04177108
74%
Diarrhoea
40%
Nausea
35%
Neutropenia
35%
Anaemia
35%
Neuropathy peripheral
26%
Alanine aminotransferase increased
23%
Alopecia
23%
Hyperglycaemia
23%
Rash
21%
Asthenia
19%
Fatigue
16%
Constipation
16%
Aspartate aminotransferase increased
16%
Vomiting
14%
Mucosal inflammation
14%
Pyrexia
14%
Decreased appetite
12%
Paraesthesia
12%
Abdominal pain upper
12%
Neutrophil count decreased
12%
White blood cell count decreased
12%
Myalgia
12%
Blood alkaline phosphatase increased
12%
Blood creatinine increased
9%
Dizziness
9%
Cough
9%
Rhinorrhoea
9%
Urticaria
9%
Leukopenia
9%
Gamma-glutamyltransferase increased
9%
Peripheral sensory neuropathy
9%
Weight decreased
9%
Hypokalaemia
9%
Arthralgia
9%
Insomnia
7%
Epistaxis
7%
Hypomagnesaemia
7%
Lymphocyte count decreased
7%
Stomatitis
7%
Back pain
7%
Dyspepsia
7%
Urinary tract infection
7%
Infusion related reaction
7%
Illness
7%
Pruritus
7%
Hyperbilirubinaemia
7%
Lymphoedema
7%
Abdominal discomfort
7%
Gastrooesophageal reflux disease
5%
Septic shock
5%
Cellulitis
5%
Polyneuropathy
5%
COVID-19
5%
Hyponatraemia
5%
Headache
5%
Abdominal pain
5%
Oedema peripheral
5%
Hypothyroidism
5%
Bone pain
5%
Dyspnoea
5%
Erythema
5%
Blood glucose increased
5%
Lymphopenia
2%
Cholecystitis infective
2%
Pyelonephritis
2%
Blood albumin decreased
2%
Gastritis
2%
Glycosylated haemoglobin increased
2%
Hypernatraemia
2%
Musculoskeletal pain
2%
Dehydration
2%
COVID-19 pneumonia
2%
Hypersensitivity
2%
Upper gastrointestinal haemorrhage
2%
Clostridium difficile colitis
2%
Drug eruption
2%
Lipase increased
2%
Hypocalcaemia
2%
Pleural effusion
2%
Hyperkalaemia
2%
Eczema
2%
Accidental overdose
2%
Acute kidney injury
2%
Blood lactate dehydrogenase increased
2%
Blood cholesterol increased
2%
Rash maculo-papular
2%
Dry mouth
2%
Neurotoxicity
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1 Arm C: Ipatasertib Matching Placebo + Atezolizumab Matching Placebo + Paclitaxel
Cohort 1 Arm A: Ipatasertib + Atezolizumab + Paclitaxel
Cohort 1 Arm B: Ipatasertib + Atezolizumab Matching Placebo + Paclitaxel
Cohort 2 Arm A: Ipatasertib + Atezolizumab + Paclitaxe
Cohort 2 Arm B: Ipatasertib Matching Placebo+ Atezolizumab + Paclitaxel

Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort 2 Arm B: Placebo+ Atezolizumab + PaclitaxelExperimental Treatment3 Interventions
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Group II: Cohort 2 Arm A: Ipatasertib + Atezolizumab + PaclitaxelExperimental Treatment3 Interventions
TNBC participants with PD-L1 positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Group III: Cohort 1 Arm C: Placebo + Placebo + PaclitaxelExperimental Treatment3 Interventions
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib-matching placebo, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Group IV: Cohort 1 Arm B: Ipatasertib + Placebo + PaclitaxelExperimental Treatment3 Interventions
TNBC participants with PD-L1 non-positive received a combination of paclitaxel, 80 mg/m^2, IV infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, PO, QD, from Day 1 to Day 21 of each 28-day cycle and atezolizumab-matching placebo, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Group V: Cohort 1 Arm A: Ipatasertib + Atezolizumab + PaclitaxelExperimental Treatment3 Interventions
TNBC participants with programmed death-ligand 1 (PD-L1) non-positive received a combination of paclitaxel, 80 milligrams per meter square (mg/m^2), intravenous (IV) infusion on Days 1, 8, and 15 of each 28-day cycle and ipatasertib, 400 mg, orally (PO), once daily (QD), from Day 1 to Day 21 of each 28-day cycle and atezolizumab, 840 mg, IV infusion on Day 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or withdrawal of consent, whichever occurred first.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
2011
Completed Phase 3
~2320
Atezolizumab
2017
Completed Phase 3
~5860
Placebo for Atezolizumab
2019
Completed Phase 3
~250
Placebo for Ipatasertib
2019
Completed Phase 3
~250
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,432 Previous Clinical Trials
1,090,081 Total Patients Enrolled
160 Trials studying Breast Cancer
91,442 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,798 Total Patients Enrolled
138 Trials studying Breast Cancer
72,096 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are Ipatasertib's most common therapeutic benefits?

"Ipatasertib is most commonly used for treatment of metastatic bladder cancer. It can also be prescribed to treat various conditions like acquired immunodeficiency syndrome, advanced thymoma, small cell lung cancer (sclc)."

Answered by AI

What previous studies have there been with Ipatasertib?

"Ipatasertib is being studied in 1204 separate clinical trials, with 292 of those currently active. The majority of these phase 3 studies are based in Woolloongabba, Queensland; however, Ipatasertib research is taking place all around the world at 63473 locations."

Answered by AI

Are investigators currently looking for new participants for this trial?

"Unfortunately, this trial is not looking for any more participants at the moment. The study was initially posted on 11/25/2019 and was most recently updated on 10/6/2022. There are currently 2436 studies actively searching for participants with triple negative breast neoplasms and 1204 studies for Ipatasertib actively recruiting participants."

Answered by AI

When might Ipatasertib be available for public use?

"Ipatasertib has received a score of 3 on Power's safety scale."

Answered by AI

Are hospitals in North America collaborating to test this new treatment?

"The primary locations for this trial are Oregon Health and Science University, Charleston Oncology, P.A., and the University of Maryland Medical Center; though there are 43 other sites where patients can enroll."

Answered by AI

How many people can sign up for this clinical trial in total?

"Unfortunately, this particular clinical trial is not recruiting patients at the moment. 25/11/2019 was when the study was first posted and 10/6/2022 marks its most recent update. However, there are 2436 trials presently enrolling participants with triple negative breast neoplasms and 1204 studies for Ipatasertib actively recruiting participants."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
2019. "A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04177108.
~45 spots leftby May 2025
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