Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug combo aims to slow advanced breast cancer growth

NCT ID NCT04650581

Disease control Sponsor: Canadian Cancer Trials Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tests whether adding the experimental drug ipatasertib to standard hormone therapy (fulvestrant) can slow the growth of advanced ER-positive, HER2-negative breast cancer. The study enrolls 250 postmenopausal women whose cancer worsened after initial treatment with a CDK 4/6 inhibitor and an aromatase inhibitor. Participants are randomly assigned to receive either fulvestrant plus ipatasertib or fulvestrant plus a placebo, and researchers track how long the cancer stays under control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

250 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Alfred Hospital

    Melbourne, Victoria, 3004, Australia

  • Algoma District Cancer Program

    Sault Ste. Marie, Ontario, P6B 0A8, Canada

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1, Canada

  • Auckland City Hospital

    Auckland, 1023, New Zealand

  • BCCA - Cancer Centre for the Southern Interior

    Kelowna, British Columbia, V1Y 5L3, Canada

  • BCCA - Fraser Valley Cancer Centre

    Surrey, British Columbia, V3V 1Z2, Canada

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6, Canada

  • CHA-Hopital Du St-Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4, Canada

  • Canberra Hospital

    Garran, ACT 2605, Australia

  • Centre Integre de Sante et de Services Sociaux

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Fiona Stanley Hospital

    Murdoch, Western Australia, 6150, Australia

  • Frankston Hospital

    Frankston, Victoria, 3199, Australia

  • Gosford Hospital

    Gosford, New South Wales, 2250, Australia

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2, Canada

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7, Canada

  • Lake Macquarie Private Hospital

    Gateshead, New South Wales, 2324, Australia

  • London Regional Cancer Program

    London, Ontario, N6A 5W9, Canada

  • Macquarie University Hospital

    Macquarie University, New South Wales, 2109, Australia

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6, Canada

  • QEII Health Sciences Centre

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2, Canada

  • Royal Brisbane and Womens Hospital

    Herston, 4029, Australia

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2, Canada

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4, Canada

  • Shoalhaven Cancer Care Centre

    Nowra, New South Wales, 2541, Australia

  • Southern Highlands Cancer Centre

    Bowral, New South Wales, 2576, Australia

  • St John of God Bunbury

    Bunbury, Western Australia, 6230, Australia

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9, Canada

  • Sunshine Coast University Hospital

    Birtinya, Queensland, 4575, Australia

  • Sunshine Hospital

    St Albans, Victoria, 3021, Australia

  • The Northern Hospital

    Epping, Victoria, 3076, Australia

  • Thunder Bay Regional Health Sciences Centre/

    Thunder Bay, Ontario, P7B 6V4, Canada

  • Toowoomba Hospital

    Toowoomba, Queensland, 4350, Australia

  • University Health Network

    Toronto, Ontario, M5G 2M9, Canada

  • Victorian Breast and Oncology Care

    East Melbourne, Victoria, 3002, Australia

  • Wellington Cancer Centre, Wellington Hospital

    Wellington, 2, New Zealand

  • William Osler Health System

    Brampton, Ontario, L6R 3J7, Canada

  • Windsor Regional Cancer Centre

    Windsor, Ontario, N8W 2X3, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.