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Estrogen Receptor Antagonist
Ipatasertib for Breast Cancer (IPATunity150 Trial)
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 from randomization in phase 3 to the first documentation of a 10-point or more decrease from baseline in the pf scale of the eortc qlq-c30, up to approx 64 months
Awards & highlights
IPATunity150 Trial Summary
This trial is testing a new combination of drugs to treat breast cancer that has progressed despite other treatments. The first part of the trial will test safety and how well the body absorbs the new drug. The second part will compare the new combination to a standard combination to see if it works better.
Eligible Conditions
- Breast Cancer
IPATunity150 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from randomization in phase 3 to the first documentation of a 10-point or more decrease from baseline in the rf scale of the eortc qlq-c30, up to approx 64 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization in phase 3 to the first documentation of a 10-point or more decrease from baseline in the rf scale of the eortc qlq-c30, up to approx 64 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-Free Survival (PFS) in Intent-to-Treat (ITT), as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Progression-Free Survival (PFS) in Patients with PIK3CA/AKT1/PTEN Altered Tumors, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Secondary outcome measures
Clinical Benefit Rate (CBR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Duration of Objective Response (DOR) as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)
Number of Participants with Adverse Events
+9 moreSide effects data
From 2023 Phase 3 trial • 242 Patients • NCT0417710874%
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%
Cellulitis
5%
Septic shock
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%
Musculoskeletal pain
2%
Cholecystitis infective
2%
Pyelonephritis
2%
Blood albumin decreased
2%
Gastritis
2%
Glycosylated haemoglobin increased
2%
Hypernatraemia
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
IPATunity150 Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Phase 1b and Phase 3: Ipatasertib + Palbociclib +FulvestrantExperimental Treatment3 Interventions
Group II: Phase 3: Placebo + Palbociclib + FulvestrantPlacebo Group3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3690
Ipatasertib
2011
Completed Phase 3
~2320
Palbociclib
2017
Completed Phase 3
~3760
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,089,034 Total Patients Enrolled
159 Trials studying Breast Cancer
91,447 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have already received treatment with fulvestrant or other medications that lower estrogen receptor activity.You have already received a certain type of medication called CDK4/6 inhibitor for advanced breast cancer.You have been treated before with certain medications called PI3K inhibitors, mTOR inhibitors, or AKT inhibitors.You have a history of or currently have a condition called inflammatory bowel disease that causes inflammation in your bowels.You have a specific type of breast cancer called HR+ HER2- adenocarcinoma that has spread and cannot be surgically removed.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 3: Placebo + Palbociclib + Fulvestrant
- Group 2: Phase 1b and Phase 3: Ipatasertib + Palbociclib +Fulvestrant
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some key findings of other Ipatasertib research?
"Ipatasertib was first studied in 2004 and, as of today, 18395 total trials have been completed. There are currently 267 active studies, a fair number of which are being conducted in Victoria, British Columbia."
Answered by AI
Are there any more participants needed for this research project?
"This study is no longer recruiting patients. The study's last update was on September 13th, 2022. However, if you are still interested in participating in clinical trials, there are 2677 trials for breast cancer and 267 for Ipatasertib currently looking for patients."
Answered by AI
How many individuals can join this clinical trial at most?
"Breast cancer: 2677 clinical trials are presently admitting patients. Ipatasertib: There are 267 trials actively searching for participants."
Answered by AI
For what purpose is Ipatasertib most commonly prescribed?
"Ipatasertib is an effective treatment option for patients with malignant neoplasms, a pik3ca gene mutation, and disease progression."
Answered by AI
Could you please tell me how many different hospitals are conducting this trial at the moment?
"This trial has 29 operating locations, including BC Cancer - Victoria in Victoria, USC Norris Cancer Center; USC Oncology Hematology Newport Beach in Newport Beach, and BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre) in Kelowna, among others."
Answered by AI
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