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Estrogen Receptor Antagonist
Fulvestrant + Ipatasertib for Breast Cancer (FINER Trial)
Phase 3
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0 or 1
≥ 18 years of age
Must not have
Type 1 or Type 2 diabetes mellitus requiring insulin
Mean QT interval corrected for heart rate (QTc) ≥ 480 msec by ECG or history of familial long QT syndrome
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Summary
This trial will test whether Ipatasertib can help treat breast cancer that has progressed despite standard hormone therapy.
Who is the study for?
This trial is for post-menopausal women or those with ovarian suppression, aged 18+, who have advanced ER+ and HER-2 negative breast cancer that has worsened after treatment with CDK 4/6 inhibitors and aromatase inhibitors. They must be in good health otherwise, not on other cancer treatments, and haven't used certain drugs like fulvestrant or PI3K pathway inhibitors.
What is being tested?
The study tests if adding Ipatasertib to the standard therapy Fulvestrant can slow down breast cancer growth. Participants will either receive Ipatasertib plus Fulvestrant or a placebo alongside Fulvestrant to compare effectiveness.
What are the potential side effects?
Possible side effects include digestive issues, changes in blood sugar levels (which could affect diabetics), increased cholesterol or triglycerides, liver problems, heart rhythm changes (QTc prolongation), allergic reactions to drug components, and infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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I am 18 years old or older.
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I am post-menopausal or will use ovarian suppression if pre-menopausal.
Select...
I have had only one prior treatment with a CDK 4/6 inhibitor and an AI for my advanced disease.
Select...
I am not currently on any cancer treatments.
Select...
My last treatment before this study was with CDK 4/6 inhibitor and AI.
Select...
I have had only one prior treatment with a CDK 4/6 inhibitor and an AI for my advanced disease.
Select...
My blood and organs are functioning well without any help.
Select...
My breast cancer is ER positive and HER-2 negative.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have diabetes and need insulin.
Select...
My heart's electrical activity (QTc) is 480 msec or more, or I have a family history of long QT syndrome.
Select...
I have previously been treated with medications targeting estrogen or the PI3K pathway.
Select...
I have a serious liver condition.
Select...
I do not have any active or uncontrolled infections or serious illnesses.
Select...
I have high cholesterol or triglycerides that isn't well-controlled.
Select...
I have had lung disease or infections due to a weak immune system.
Select...
I have an active bowel condition that affects my ability to take pills.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2024 Phase 3 trial • 1101 Patients • NCT0307223879%
Diarrhoea
38%
Hyperglycaemia
28%
Nausea
26%
Rash
22%
Fatigue
20%
Alanine aminotransferase increased
19%
Anaemia
18%
Decreased appetite
18%
Asthenia
17%
Vomiting
17%
Aspartate aminotransferase increased
15%
Back pain
14%
Hypertension
13%
Oedema peripheral
12%
Weight decreased
12%
Arthralgia
10%
Headache
9%
Rash maculo-papular
8%
Hypokalaemia
8%
Pruritus
8%
Constipation
8%
Nasopharyngitis
8%
Cough
7%
Urinary tract infection
7%
Pain in extremity
7%
Upper respiratory tract infection
7%
Bone pain
7%
Dizziness
6%
Blood creatinine increased
6%
Dyspepsia
6%
Hypertriglyceridaemia
6%
Abdominal pain
6%
Pyrexia
6%
Fall
6%
Haematuria
6%
Dyspnoea
5%
Hot flush
5%
Musculoskeletal pain
4%
Insomnia
2%
Pneumonia
2%
Dehydration
1%
Erythema multiforme
1%
Cardiac failure
1%
Cellulitis
1%
Sepsis
1%
Acute kidney injury
1%
Nephrolithiasis
1%
Acute myocardial infarction
1%
Myocardial infarction
1%
Death
1%
Pulmonary embolism
1%
Septic shock
1%
Deep vein thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + Abiraterone
Ipatasertib + Abiraterone
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ipatasertib + FulvestrantExperimental Treatment2 Interventions
Group II: PlaceboPlacebo Group2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipatasertib
2017
Completed Phase 3
~3490
Fulvestrant
2011
Completed Phase 3
~3890
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheIndustry Sponsor
2,444 Previous Clinical Trials
1,092,872 Total Patients Enrolled
158 Trials studying Breast Cancer
90,400 Patients Enrolled for Breast Cancer
Canadian Cancer Trials GroupLead Sponsor
127 Previous Clinical Trials
68,024 Total Patients Enrolled
8 Trials studying Breast Cancer
8,474 Patients Enrolled for Breast Cancer
Stephen ChiaStudy ChairBCCA - Vancouver Cancer Centre, BC Canada
3 Previous Clinical Trials
518 Total Patients Enrolled
2 Trials studying Breast Cancer
503 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am fully active or can carry out light work.I am 18 years old or older.I am post-menopausal or will use ovarian suppression if pre-menopausal.There is proof that you have a documented disease from either clinical or radiological exams.I have diabetes and need insulin.I have had only one prior treatment with a CDK 4/6 inhibitor and an AI for my advanced disease.I am not currently on any cancer treatments.My heart's electrical activity (QTc) is 480 msec or more, or I have a family history of long QT syndrome.I have previously been treated with medications targeting estrogen or the PI3K pathway.I have a serious liver condition.I have brain metastases that are either untreated or causing symptoms.You have known blood clotting problems.I do not have any active or uncontrolled infections or serious illnesses.I have high cholesterol or triglycerides that isn't well-controlled.I have had lung disease or infections due to a weak immune system.I have an active bowel condition that affects my ability to take pills.My last treatment before this study was with CDK 4/6 inhibitor and AI.I have had only one prior treatment with a CDK 4/6 inhibitor and an AI for my advanced disease.My blood and organs are functioning well without any help.My breast cancer is ER positive and HER-2 negative.My cancer progressed despite initial treatment with CDK 4/6 inhibitor and AI.
Research Study Groups:
This trial has the following groups:- Group 1: Ipatasertib + Fulvestrant
- Group 2: Placebo
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.
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