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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

250

Participants

Timeline

Start Date

January 27, 2021

Primary Completion Date

May 23, 2025

Study Completion Date

December 31, 2026

Conditions
Breast Cancer
Interventions
DRUG

Ipatasertib

400 mg PO QD days 1-21 every 28 days

DRUG

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

Trial Locations (39)

2

Wellington Cancer Centre, Wellington Hospital, Wellington

1023

Auckland City Hospital, Auckland

2109

Macquarie University Hospital, Macquarie University

2250

Gosford Hospital, Gosford

2324

Lake Macquarie Private Hospital, Gateshead

2541

Shoalhaven Cancer Care Centre, Nowra

2576

Southern Highlands Cancer Centre, Bowral

3002

Victorian Breast and Oncology Care, East Melbourne

3004

Alfred Hospital, Melbourne

3021

Sunshine Hospital, St Albans

3076

The Northern Hospital, Epping

3199

Frankston Hospital, Frankston

4029

Royal Brisbane and Womens Hospital, Herston

4350

Toowoomba Hospital, Toowoomba

4575

Sunshine Coast University Hospital, Birtinya

6150

Fiona Stanley Hospital, Murdoch

6230

St John of God Bunbury, Bunbury

ACT 2605

Canberra Hospital, Garran

V1Y 5L3

BCCA - Cancer Centre for the Southern Interior, Kelowna

V3V 1Z2

BCCA - Fraser Valley Cancer Centre, Surrey

V5Z 4E6

BCCA - Vancouver Cancer Centre, Vancouver

E2L 4L2

Regional Health Authority B, Zone 2, Saint John

B3H 1V7

QEII Health Sciences Centre, Halifax

L4M 6M2

Royal Victoria Regional Health Centre, Barrie

L6R 3J7

William Osler Health System, Brampton

L8V 5C2

Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton

K7L 2V7

Kingston Health Sciences Centre, Kingston

N6A 5W9

London Regional Cancer Program, London

L3Y 2P9

Stronach Regional Health Centre at Southlake, Newmarket

K1H 8L6

Ottawa Hospital Research Institute, Ottawa

P6B 0A8

Algoma District Cancer Program, Sault Ste. Marie

P7B 6V4

Thunder Bay Regional Health Sciences Centre/, Thunder Bay

M5G 2M9

University Health Network, Toronto

N8W 2X3

Windsor Regional Cancer Centre, Windsor

J4V 2H1

Centre Integre de Sante et de Services Sociaux, Greenfield Park

H2X 3E4

CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal

G1S 4L8

CHA-Hopital Du St-Sacrement, Québec

S4T 7T1

Allan Blair Cancer Centre, Regina

S7N 4H4

Saskatoon Cancer Centre, Saskatoon

All Listed Sponsors
collaborator

Hoffmann-La Roche

INDUSTRY

lead

Canadian Cancer Trials Group

NETWORK

NCT04650581 - 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 | Biotech Hunter | Biotech Hunter