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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04650581
Registration number
NCT04650581
Ethics application status
Date submitted
24/11/2020
Date registered
2/12/2020
Date last updated
9/05/2024
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
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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
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Secondary ID [1]
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2101
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Secondary ID [2]
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MA40
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Universal Trial Number (UTN)
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Trial acronym
FINER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Breast Cancer
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Condition category
Condition code
Cancer
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free survival (PFS) using RECIST 1.1
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Assessment method [1]
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Timepoint [1]
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5 years
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Secondary outcome [1]
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To compare the two treatment arms with respect to investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN altered cohort
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Assessment method [1]
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Timepoint [1]
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5 years
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Secondary outcome [2]
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Investigator assessed PFS (per RECIST 1.1) in the PIK3CA/AKT1/PTEN non-altered cohort
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Assessment method [2]
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Timepoint [2]
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5 years
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Secondary outcome [3]
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PFS as assessed by blinded central radiology review in all enrolled patients, PIK3CA/AKT1/PTEN altered and non-altered cohorts
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Assessment method [3]
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Timepoint [3]
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5 years
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Secondary outcome [4]
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Response rate (RR) (per RECIST 1.1)
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Assessment method [4]
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Timepoint [4]
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5 years
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Secondary outcome [5]
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Duration of Response (DoR)
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Assessment method [5]
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Timepoint [5]
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5 years
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Secondary outcome [6]
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Clinical Benefit Rate (CBR);
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Assessment method [6]
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Timepoint [6]
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5 years
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Secondary outcome [7]
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Overall survival (OS)
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Assessment method [7]
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Timepoint [7]
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5 years
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Secondary outcome [8]
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Time to commencement of subsequent line of systemic therapy or death (TSST)
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Assessment method [8]
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Timepoint [8]
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5 years
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Secondary outcome [9]
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Number of participants with treatment-related adverse events as assessed by CTCAE version 5.0
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Assessment method [9]
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Timepoint [9]
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5 years
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Secondary outcome [10]
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Quality of Life (QOL) as measured using EORTC QLQ-C30 questionnaire
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Assessment method [10]
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Timepoint [10]
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5 years
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Secondary outcome [11]
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Adverse events as measured using NCI PRO-CTCAE questionnaire
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Assessment method [11]
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Timepoint [11]
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5 years
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Secondary outcome [12]
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Economic Evaluation of healthcare utilization using average cost per study subject by treatment arm to estimate an overall mean cost per study arm.
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Assessment method [12]
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Timepoint [12]
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5 years
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Secondary outcome [13]
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Economic Evaluation of health utilities measured using EQ-5D-5L
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Assessment method [13]
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Timepoint [13]
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5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
27/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
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Accrual to date
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Final
250
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Southern Highlands Cancer Centre - Bowral
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Recruitment hospital [2]
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Lake Macquarie Private Hospital - Gateshead
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Recruitment hospital [3]
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Gosford Hospital - Gosford
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Recruitment hospital [4]
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Macquarie University Hospital - Macquarie University
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Recruitment hospital [5]
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Shoalhaven Cancer Care Centre - Nowra
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Recruitment hospital [6]
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Sunshine Coast University Hospital - Birtinya
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Recruitment hospital [7]
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Toowoomba Hospital - Toowoomba
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Recruitment hospital [8]
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Victorian Breast and Oncology Care - East Melbourne
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Recruitment hospital [9]
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The Northern Hospital - Epping
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Recruitment hospital [10]
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Frankston Hospital - Frankston
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Recruitment hospital [11]
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Alfred Hospital - Melbourne
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Recruitment hospital [12]
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Sunshine Hospital - St. Albans
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Recruitment hospital [13]
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St John of God Bunbury - Bunbury
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Recruitment hospital [14]
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Fiona Stanley Hospital - Murdoch
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Recruitment hospital [15]
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Canberra Hospital - Garran
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Recruitment hospital [16]
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Royal Brisbane and Womens Hospital - Herston
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Recruitment postcode(s) [1]
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2576 - Bowral
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Recruitment postcode(s) [2]
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2324 - Gateshead
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Recruitment postcode(s) [3]
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2250 - Gosford
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Recruitment postcode(s) [4]
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2109 - Macquarie University
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Recruitment postcode(s) [5]
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2541 - Nowra
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Recruitment postcode(s) [6]
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4575 - Birtinya
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Recruitment postcode(s) [7]
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4350 - Toowoomba
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Recruitment postcode(s) [8]
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3002 - East Melbourne
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Recruitment postcode(s) [9]
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3076 - Epping
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Recruitment postcode(s) [10]
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3199 - Frankston
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Recruitment postcode(s) [11]
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3004 - Melbourne
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Recruitment postcode(s) [12]
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3021 - St. Albans
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Recruitment postcode(s) [13]
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6230 - Bunbury
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Recruitment postcode(s) [14]
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6150 - Murdoch
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Recruitment postcode(s) [15]
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ACT 2605 - Garran
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Recruitment postcode(s) [16]
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4029 - Herston
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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British Columbia
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Country [2]
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Canada
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State/province [2]
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New Brunswick
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Country [3]
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Canada
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State/province [3]
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Nova Scotia
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Country [4]
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Canada
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State/province [4]
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Ontario
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Country [5]
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Canada
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State/province [5]
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Quebec
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Country [6]
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Canada
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State/province [6]
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Saskatchewan
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Country [7]
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New Zealand
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State/province [7]
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Auckland
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Country [8]
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New Zealand
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State/province [8]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Canadian Cancer Trials Group
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Hoffmann-La Roche
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief 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).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04650581
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Stephen Chia
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Address
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BCCA - Vancouver Cancer Centre, BC Canada
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04650581
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