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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04650581
Other study ID # MA40
Secondary ID 2101M041883
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 27, 2021
Est. completion date December 31, 2026

Study information

Verified date May 2024
Source Canadian Cancer Trials Group
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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).


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 250
Est. completion date December 31, 2026
Est. primary completion date June 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 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


Related Conditions & MeSH terms


Intervention

Drug:
Ipatasertib
400 mg PO QD days 1-21 every 28 days
Fulvestrant
500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles
Other:
Placebo
PO QD days 1-21 every 28 days

Locations

Country Name City State
Australia Sunshine Coast University Hospital Birtinya Queensland
Australia Southern Highlands Cancer Centre Bowral New South Wales
Australia St John of God Bunbury Bunbury Western Australia
Australia Victorian Breast and Oncology Care East Melbourne Victoria
Australia The Northern Hospital Epping Victoria
Australia Frankston Hospital Frankston Victoria
Australia Canberra Hospital Garran
Australia Lake Macquarie Private Hospital Gateshead New South Wales
Australia Gosford Hospital Gosford New South Wales
Australia Royal Brisbane and Womens Hospital Herston
Australia Macquarie University Hospital Macquarie University New South Wales
Australia Alfred Hospital Melbourne Victoria
Australia Fiona Stanley Hospital Murdoch Western Australia
Australia Shoalhaven Cancer Care Centre Nowra New South Wales
Australia Sunshine Hospital St. Albans Victoria
Australia Toowoomba Hospital Toowoomba Queensland
Canada Royal Victoria Regional Health Centre Barrie Ontario
Canada William Osler Health System Brampton Ontario
Canada Centre Integre de Sante et de Services Sociaux Greenfield Park Quebec
Canada QEII Health Sciences Centre Halifax Nova Scotia
Canada Juravinski Cancer Centre at Hamilton Health Sciences Hamilton Ontario
Canada BCCA - Cancer Centre for the Southern Interior Kelowna British Columbia
Canada Kingston Health Sciences Centre Kingston Ontario
Canada London Regional Cancer Program London Ontario
Canada CHUM-Centre Hospitalier de l'Universite de Montreal Montreal Quebec
Canada Stronach Regional Health Centre at Southlake Newmarket Ontario
Canada Ottawa Hospital Research Institute Ottawa Ontario
Canada CHA-Hopital Du St-Sacrement Quebec City Quebec
Canada Allan Blair Cancer Centre Regina Saskatchewan
Canada Regional Health Authority B, Zone 2 Saint John New Brunswick
Canada Saskatoon Cancer Centre Saskatoon Saskatchewan
Canada Algoma District Cancer Program Sault Ste. Marie Ontario
Canada BCCA - Fraser Valley Cancer Centre Surrey British Columbia
Canada Thunder Bay Regional Health Sciences Centre/ Thunder Bay Ontario
Canada University Health Network Toronto Ontario
Canada BCCA - Vancouver Cancer Centre Vancouver British Columbia
Canada Windsor Regional Cancer Centre Windsor Ontario
New Zealand Auckland City Hospital Auckland
New Zealand Wellington Cancer Centre, Wellington Hospital Wellington

Sponsors (2)

Lead Sponsor Collaborator
Canadian Cancer Trials Group Hoffmann-La Roche

Countries where clinical trial is conducted

Australia,  Canada,  New Zealand, 

Outcome

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