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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04650581




Registration number
NCT04650581
Ethics application status
Date submitted
24/11/2020
Date registered
2/12/2020

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2101
Secondary ID [2] 0 0
MA40
Universal Trial Number (UTN)
Trial acronym
FINER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ipatasertib
Treatment: Drugs - Fulvestrant
Other interventions - Placebo

Experimental: Ipatasertib + Fulvestrant -

Placebo comparator: Placebo -


Treatment: Drugs: Ipatasertib
400 mg PO QD days 1-21 every 28 days

Treatment: Drugs: Fulvestrant
500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles

Other interventions: Placebo
PO QD days 1-21 every 28 days
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free survival (PFS) using RECIST 1.1
Timepoint [1] 0 0
5 years
Secondary outcome [1] 0 0
To compare the two treatment arms with respect to investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN altered cohort
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN non-altered cohort
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
PFS as assessed by blinded central radiology review in all enrolled patients, PIK3CA/AKT1/PTEN altered and non-altered cohorts
Timepoint [3] 0 0
5 years
Secondary outcome [4] 0 0
Response rate (RR) (per RECIST 1.1)
Timepoint [4] 0 0
5 years
Secondary outcome [5] 0 0
Duration of Response (DoR)
Timepoint [5] 0 0
5 years
Secondary outcome [6] 0 0
Clinical Benefit Rate (CBR);
Timepoint [6] 0 0
5 years
Secondary outcome [7] 0 0
Overall survival (OS)
Timepoint [7] 0 0
5 years
Secondary outcome [8] 0 0
Time to commencement of subsequent line of systemic therapy or death (TSST)
Timepoint [8] 0 0
5 years
Secondary outcome [9] 0 0
Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
Timepoint [9] 0 0
5 years
Secondary outcome [10] 0 0
Quality of Life (QOL) as measured using EORTC QLQ-C30 questionnaire
Timepoint [10] 0 0
5 years
Secondary outcome [11] 0 0
Adverse events as measured using NCI PRO-CTCAE questionnaire
Timepoint [11] 0 0
5 years
Secondary outcome [12] 0 0
Economic Evaluation of healthcare utilization using average cost per study subject by treatment arm to estimate an overall mean cost per study arm.
Timepoint [12] 0 0
5 years
Secondary outcome [13] 0 0
Economic Evaluation of health utilities measured using EQ-5D-5L
Timepoint [13] 0 0
5 years

Eligibility
Key inclusion criteria
* 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
* 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
Accrual to date
Final
250
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Southern Highlands Cancer Centre - Bowral
Recruitment hospital [2] 0 0
Lake Macquarie Private Hospital - Gateshead
Recruitment hospital [3] 0 0
Gosford Hospital - Gosford
Recruitment hospital [4] 0 0
Macquarie University Hospital - Macquarie University
Recruitment hospital [5] 0 0
Shoalhaven Cancer Care Centre - Nowra
Recruitment hospital [6] 0 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [7] 0 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [8] 0 0
Victorian Breast and Oncology Care - East Melbourne
Recruitment hospital [9] 0 0
The Northern Hospital - Epping
Recruitment hospital [10] 0 0
Frankston Hospital - Frankston
Recruitment hospital [11] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [12] 0 0
Sunshine Hospital - St. Albans
Recruitment hospital [13] 0 0
St John of God Bunbury - Bunbury
Recruitment hospital [14] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [15] 0 0
Canberra Hospital - Garran
Recruitment hospital [16] 0 0
Royal Brisbane and Womens Hospital - Herston
Recruitment postcode(s) [1] 0 0
2576 - Bowral
Recruitment postcode(s) [2] 0 0
2324 - Gateshead
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2109 - Macquarie University
Recruitment postcode(s) [5] 0 0
2541 - Nowra
Recruitment postcode(s) [6] 0 0
4575 - Birtinya
Recruitment postcode(s) [7] 0 0
4350 - Toowoomba
Recruitment postcode(s) [8] 0 0
3002 - East Melbourne
Recruitment postcode(s) [9] 0 0
3076 - Epping
Recruitment postcode(s) [10] 0 0
3199 - Frankston
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
3021 - St. Albans
Recruitment postcode(s) [13] 0 0
6230 - Bunbury
Recruitment postcode(s) [14] 0 0
6150 - Murdoch
Recruitment postcode(s) [15] 0 0
ACT 2605 - Garran
Recruitment postcode(s) [16] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
British Columbia
Country [2] 0 0
Canada
State/province [2] 0 0
New Brunswick
Country [3] 0 0
Canada
State/province [3] 0 0
Nova Scotia
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland
Country [8] 0 0
New Zealand
State/province [8] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
Canadian Cancer Trials Group
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Hoffmann-La Roche
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Stephen Chia
Address 0 0
BCCA - Vancouver Cancer Centre, BC Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04650581