Breast CancerPhase 3FINERNCT04650581
Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
A Phase 3 study testing Ipatasertib and Fulvestrant in people with Breast Cancer, run by Canadian Cancer Trials Group at 39 sites in 3 countries.
Trial summary
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Ipatasertib and Fulvestrant
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 39 sitesin 3 countries
- Study dates
- 27 Jan 2021to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
- Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
- Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
- Evidence of clinically and/or radiologically documented disease
- ≥ 18 years of age
- ECOG performance status of 0 or 1
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- No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy
- Must not have received more than one prior line of treatment with a CDK 4/6 inhibitor and an AI in the advanced disease setting.
- Treatment with CDK 4/6 inhibitor and AI must have been the most recent treatment prior to registration for this study
- Adequate hematology and organ function, in the absence of growth factors
- Absolute neutrophils > 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin > 90 g/L
- Total Bilirubin ≤ 1.5 x ULN (upper limit of normal) or ≤ 3 x ULN if confirmed Gilbert's Syndrome
- ALT and AST ≤ 2.5 x ULN (or ≤ 5.0 x ULN if liver or bone metastasis)
- Alkaline phosphatase ≤ 2.0 x ULN (or ≤ 5.0 x ULN if liver metastases, ≤ 7.0 x ULN if bone metastasis)
- Fasting glucose ≤ 8.3 mmol/L
- HbA1c ≤ 7.5%
- Serum albumin ≥ 30 g/L
- INR ≤ 1.2
- Serum Creatinine or Creatinine clearance ≤ 1.5 x ULN or ≥ 50 mL/min; measured directly by 24-hour urine sampling or as calculated by Crockcroft and Gault equation
Who cannot join
- Untreated or symptomatic CNS metastases, radiation treatment for CNS metastases within 28 days
- Active inflammatory bowel disease, bowel inflammation, inability to swallow oral medication or GI condition that alters oral absorption
- Prior treatment with fulvestrant, selective estrogen receptor degraders (SERDs) or known inhibitors of the PI3K pathway including PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
- Mean QT interval corrected for heart rate (QTc) ≥ 480 msec by ECG or history of familial long QT syndrome
- Active or uncontrolled infections or serious illnesses or medical conditions
- Clinically significant liver diseases
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- History of lung disease or history of opportunistic infections
- Type 1 or Type 2 diabetes mellitus requiring insulin
- Grade ≥ 2 uncontrolled hypercholesterolemia or hypertriglyceridemia
- Known abnormalities in coagulation
- History of hypersensitivity to the study drugs or components
- Pregnant or lactating women
Trial locations and contacts
39 sites in 3 countries.
39 sites in 3 countries
Canada21 sites
Royal Victoria Regional Health Centre
Barrie, Ontario, L4M 6M2
William Osler Health System
Brampton, Ontario, L6R 3J7
Centre Integre de Sante et de Services Sociaux
Greenfield Park, Quebec, J4V 2H1
QEII Health Sciences Centre
Halifax, Nova Scotia, B3H 1V7
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, L8V 5C2
BCCA - Cancer Centre for the Southern Interior
Kelowna, British Columbia, V1Y 5L3
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
London Regional Cancer Program
London, Ontario, N6A 5W9
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 3E4
Stronach Regional Health Centre at Southlake
Newmarket, Ontario, L3Y 2P9
Ottawa Hospital Research Institute
Ottawa, Ontario, K1H 8L6
CHA-Hopital Du St-Sacrement
Québec, Quebec, G1S 4L8
Allan Blair Cancer Centre
Regina, Saskatchewan, S4T 7T1
Regional Health Authority B, Zone 2
Saint John, New Brunswick, E2L 4L2
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, S7N 4H4
Algoma District Cancer Program
Sault Ste. Marie, Ontario, P6B 0A8
BCCA - Fraser Valley Cancer Centre
Surrey, British Columbia, V3V 1Z2
Thunder Bay Regional Health Sciences Centre/
Thunder Bay, Ontario, P7B 6V4
University Health Network
Toronto, Ontario, M5G 2M9
BCCA - Vancouver Cancer Centre
Vancouver, British Columbia, V5Z 4E6
Windsor Regional Cancer Centre
Windsor, Ontario, N8W 2X3
Australia16 sites
Sunshine Coast University Hospital
Birtinya, Queensland, 4575
Southern Highlands Cancer Centre
Bowral, New South Wales, 2576
St John of God Bunbury
Bunbury, Western Australia, 6230
Victorian Breast and Oncology Care
East Melbourne, Victoria, 3002
The Northern Hospital
Epping, Victoria, 3076
Frankston Hospital
Frankston, Victoria, 3199
Canberra Hospital
Garran, ACT 2605
Lake Macquarie Private Hospital
Gateshead, New South Wales, 2324
Gosford Hospital
Gosford, New South Wales, 2250
Royal Brisbane and Womens Hospital
Herston, 4029
Macquarie University Hospital
Macquarie University, New South Wales, 2109
Alfred Hospital
Melbourne, Victoria, 3004
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
Shoalhaven Cancer Care Centre
Nowra, New South Wales, 2541
Sunshine Hospital
St Albans, Victoria, 3021
Toowoomba Hospital
Toowoomba, Queensland, 4350
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
Wellington Cancer Centre, Wellington Hospital
Wellington, 2
About this study
Official title: Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
Read the detailed description
Patients enrolled in this study will receive either Ipatasertib plus Fulvestrant or placebo (a substance that looks like the study drug but does not have any active or medicinal ingredient) plus Fulvestant. The study will provide information about the ability of Ipatasertib plus Fulvestrant to control the cancer, the side effects and safety of the treatment, how patients feel while taking the treatment and associated costs.
- Conditions
- Breast Cancer
- Being tested
- Ipatasertib, Fulvestrant, Placebo
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpatasertibDrug
400 mg PO QD days 1-21 every 28 days
FulvestrantDrug
500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles
PlaceboOther
PO QD days 1-21 every 28 days
| Study group | Role | What they receive |
|---|---|---|
| Ipatasertib + Fulvestrant | Experimental | Not described Receives: Drug: Ipatasertib; Drug: Fulvestrant |
| Placebo | Placebo comparator | Not described Receives: Drug: Fulvestrant; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Progression-free Survival (PFS) Using RECIST 1.1
Progression-free survival (PFS) defined as time from randomization to disease progression or death from any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: 4 years
Secondary outcomes (2)
To Compare the Two Treatment Arms With Respect to Investigator Assessed PFS (Per RECIST 1.1) in the PIK3CA/AKT1/PTEN Altered Cohort
The PFS is tested in the PIK3CA/PTEN/AKT1 altered status subset under the same 0.05 significance level among the 111 subjects in the PIK3CA/PTEN/AKT1 altered status subset
Measured: 4 years
Commencement of Subsequent Line of Systemic Therapy or Death (TSST)
Number of patients with commencement of subsequent line of systemic therapy or death between enrollment and the end of study
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start27 Jan 2021
- Primary completion23 May 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Stephen Chia, Study chair, BCCA - Vancouver Cancer Centre, BC Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650581
- Sponsor's protocol ID
- MA40
- Other IDs
- 2101, M041883
- Acronym
- FINER
- Status last verified
- Jan 2026
- First submitted
- 24 Nov 2020
- Last updated
- 13 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
- ClinicalTrials.gov ID
- NCT04650581
- Acronym / sponsor ID
- FINER / MA40
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Canadian Cancer Trials GroupResearch network
- Collaborators
- Hoffmann-La Roche
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 23 May 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Posted 28 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
Detailed description
Patients enrolled in this study will receive either Ipatasertib plus Fulvestrant or placebo (a substance that looks like the study drug but does not have any active or medicinal ingredient) plus Fulvestant. The study will provide information about the ability of Ipatasertib plus Fulvestrant to control the cancer, the side effects and safety of the treatment, how patients feel while taking the treatment and associated costs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipatasertib + Fulvestrant | Experimental | Drug: Ipatasertib, Drug: Fulvestrant |
| Placebo | Placebo comparator | Drug: Fulvestrant, Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
- Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
- Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
- Evidence of clinically and/or radiologically documented disease
- ≥ 18 years of age
Key exclusion criteria (12 listed)
- Untreated or symptomatic CNS metastases, radiation treatment for CNS metastases within 28 days
- Active inflammatory bowel disease, bowel inflammation, inability to swallow oral medication or GI condition that alters oral absorption
- Prior treatment with fulvestrant, selective estrogen receptor degraders (SERDs) or known inhibitors of the PI3K pathway including PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
- Mean QT interval corrected for heart rate (QTc) ≥ 480 msec by ECG or history of familial long QT syndrome
- Active or uncontrolled infections or serious illnesses or medical conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipatasertib400 mg PO QD days 1-21 every 28 days | Drug | Ipatasertib + Fulvestrant |
| Fulvestrant500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles | Drug | Ipatasertib + Fulvestrant, Placebo |
| PlaceboPO QD days 1-21 every 28 days | Other | Placebo |
Primary outcome
Number of Participants With Progression-free Survival (PFS) Using RECIST 1.1
Time frame: 4 years
Progression-free survival (PFS) defined as time from randomization to disease progression or death from any cause, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
2 secondary outcomes
To Compare the Two Treatment Arms With Respect to Investigator Assessed PFS (Per RECIST 1.1) in the PIK3CA/AKT1/PTEN Altered Cohort
Time frame: 4 years
Commencement of Subsequent Line of Systemic Therapy or Death (TSST)
Time frame: 4 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Chia study chair
BCCA - Vancouver Cancer Centre, BC Canada
39 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ipatasertib and Fulvestrant in people with Breast Cancer, run by Canadian Cancer Trials Group at 39 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Canada, Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Progression-free Survival (PFS) Using RECIST 1.1 (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.