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Estrogen Receptor Antagonist
Fulvestrant + Ipatasertib for Breast Cancer (FINER Trial)
Phase 3
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
FINER Trial 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.Check my eligibility
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.See study design
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.
FINER Trial 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.
Select...
I am 18 years old or older.
Select...
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.
FINER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
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) using RECIST 1.1
Secondary outcome measures
Adverse events as measured using NCI PRO-CTCAE questionnaire
Clinical Benefit Rate (CBR);
Duration of Response (DoR)
+10 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
FINER 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
2011
Completed Phase 3
~2320
Fulvestrant
2011
Completed Phase 3
~3690
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheIndustry Sponsor
2,430 Previous Clinical Trials
1,089,368 Total Patients Enrolled
159 Trials studying Breast Cancer
91,192 Patients Enrolled for Breast Cancer
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,203 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What other research has been conducted on Ipatasertib in the past?
"Ipatasertib was first studied in 2004 at Lowell General Hospital. Since then, a total of 18,371 trials have completed. At the moment, there are 166 studies actively recruiting patients--many of which are based in London, Ontario."
Answered by AI
Could you please tell me how many health facilities are participating in this experiment?
"This clinical trial has 22 participating sites, which can be found in London, Windsor, Kingston and 20 other locations. If you're interested in enrolling, try to select a location nearest to you so that travel isn't excessive."
Answered by AI
Why is Ipatasertib given to patients?
"Ipatasertib can be used to treat patients with a history of endocrine therapy, those currently suffering from disease, and breast cancer patients."
Answered by AI
Could you please tell us the level of threat Ipatasertib poses to patients?
"Ipatasertib, which is currently in Phase 3 trials, has received a safety score of 3 from our Power team. This is due to the presence of data supporting both its efficacy and safety."
Answered by AI
Are there any open slots in this clinical trial for volunteers?
"Yes, this is an ongoing trial that was originally posted on December 1st 2020. The most recent update to the listing was on October 7th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
QEII Health Sciences Centre
What portion of applicants met pre-screening criteria?
Met criteria
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