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Be Part of Research - Trial Details - Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6)

Not Recruiting

Open to: ALL

Age: 18.0 - 130.0

Medical Conditions


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.


The study is intended to show superiority of AZD9833 in combination with CDK4/6 inhibitor (palbociclib, abemaciclib or ribociclib) versus aromatase inhibitors (anastrozole or letrozole) in combination with CDK4/6 inhibitor in patients with hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative) metastatic breast cancer with detectable ESR1 mutation.

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:

Jun 2021 Apr 2025

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Dosage formulation: AZD9833 tablets will be administered orally

Intervention Arm Group : AZD9833 + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: AZD9833 placebo tablets will be administrated orally.

Intervention Arm Group : Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: anastrozole tablets will be administered orally.

Intervention Arm Group : Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: anastrozole placebo tablets will be administrated orally.

Intervention Arm Group : AZD9833 + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: letrozole tablets will be administered orally.

Intervention Arm Group : Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: letrozole placebo tablets will be administered orally.

Intervention Arm Group : AZD9833 + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: palbociclib tablets/capsules will be administered orally

Intervention Arm Group : AZD9833 + palbociclib, abemaciclib or ribociclib;Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: abemaciclib tablets will be administered orally

Intervention Arm Group : AZD9833 + palbociclib, abemaciclib or ribociclib;Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Men (when medically applicable) and pre- or peri-menopausal women are required to receive a monthly LHRH agonist.

Intervention Arm Group : AZD9833 + palbociclib, abemaciclib or ribociclib;Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib;

Intervention Type : DRUG
Intervention Description : Dosage formulation: ribociclib tablets will be administered orally

Intervention Arm Group : AZD9833 + palbociclib, abemaciclib or ribociclib;Anastrozole or letrozole + palbociclib, abemaciclib or ribociclib;



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
    Cambridge
    CB2 0QQ
  • Research Site
    Manchester
    M20 4BX
  • Research Site
    Sutton
    SM2 5PT
  • Research Site
    London
    SW3 6JJ
  • Research Site
    Nottingham
    NG5 1PB
  • Research Site
    Taunton
    TA1 5DA
  • Research Site
    Portsmouth
    PO6 3LY
  • Research Site
    London
    WC1N 3BG
  • Research Site
    Blackpool
    FY3 8NR
  • Research Site
    Newport
    NP10 8FZ
  • Research Site
    Reading
    RG2 9LH
  • Research Site
    Sheffield
    S10 2SJ


The study is sponsored by AstraZeneca




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Read full details for Trial ID: NCT04964934
Last updated 08 January 2025

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