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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

AstraZeneca Breast Cancer Study Locator Service 1-877-400-4655
az-bcsl@careboxhealth.com


AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com


Study Location:

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Be Part of Research - Trial Details - Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)
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Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292)

Recruiting

Open to: ALL

Age: 18.0 - 99.0

London Derry Guildford Taunton York

Medical Conditions

Breast Neoplasms

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


A Phase Ib/III Open-label, Randomised Study of Capivasertib plus CDK4/6 Inhibitors and Fulvestrant versus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292)

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2021 Nov 2027

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Phase Ib: Capivasertib 320 mg/ 400 mg administered PO BD 4 days on /3 days off per week for 4 weeks (28 days cycle) Phase III: : Capivasertib, administered PO BD 4 days on / 3 days off per week for 4 weeks (28 days cycle) at the dose confirmed in the phase Ib portion

Intervention Arm Group : Capivasertib Plus Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib);Capivasertib Plus Palbociclib and Fulvestrant;

Intervention Type : DRUG
Intervention Description : Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter

Intervention Arm Group : Capivasertib Plus Palbociclib and Fulvestrant;Fulvestrant and Investigator's choice of CDK4/6i (palbociclib or ribociclib);

Intervention Type : DRUG
Intervention Description : Phase Ib: 100 mg/ 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose of 125 mg.

Intervention Arm Group : Capivasertib Plus Palbociclib and Fulvestrant;

Intervention Type : DRUG
Intervention Description : Phase Ib: 200 mg/ 400 mg/ 600 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: Administered once daily for 21 days of 28-day cycle, at the dose confirmed in the phase 1b portion.

Intervention Arm Group : Capivasertib Plus Ribociclib and Fulvestrant;

Intervention Type : DRUG
Intervention Description : Phase Ib: 50 mg/ 100 mg/ 150 mg. Twice daily for 28 consecutive days to comprise a complete 28-day cycle

Intervention Arm Group : Capivasertib Plus Abemaciclib and Fulvestrant;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Research Site
    London
    SE1 9RT
  • Research Site
    Derry
    BT47 6SB
  • Research Site
    Guildford
    CU2 7XX
  • Research Site
    Taunton
    TA1 5DA
  • Research Site
    York
    YO21 8HE

AstraZeneca Clinical Study Information Center 1-877-240-9479
information.center@astrazeneca.com


AstraZeneca Breast Cancer Study Locator Service 1-877-400-4655
az-bcsl@careboxhealth.com



The study is sponsored by AstraZeneca



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Read full details for Trial ID: NCT04862663
Last updated 24 March 2025

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