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New drug combo shows promise in slowing advanced breast cancer

NCT ID NCT01992952

Disease control Sponsor: Velindre NHS Trust 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether adding a targeted drug called AZD5363 to the standard hormone therapy fulvestrant can slow the growth of advanced estrogen-receptor-positive (ER+) breast cancer. It involves 149 postmenopausal women whose cancer has worsened despite prior treatment with an aromatase inhibitor. The trial has two phases: first finding the safest dose, then comparing the combination against fulvestrant alone.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD5363 (a targeted drug) combined with fulvestrant (a hormone therapy)
What this could lead to
If it works, this could offer a new treatment option that delays cancer progression for postmenopausal women with advanced ER+ breast cancer.
What could go wrong
This is an early-phase trial (1b/2) with a small number of participants, so results may not confirm benefit. The drug combination may cause side effects or fail to improve outcomes.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

149 people

The number who actually took part.

Started

May 2014

Expected to finish

Dec 2025

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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

Female participants only

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: * Post-menopausal Women * Life expectancy 3 months * Histological confirmation of ER+ breast cancer * Clinical or histological confirmation of metastatic or locally advanced disease not amenable to surgical resection * Measurable or non-measurable disease * Adequate bone marrow, renal and hepatic function * Eastern Cooperative Oncology Group (ECOG) performance status \< or equal to 2 * Progressive disease whilst receiving an aromatase inhibitor (AI) for metastatic breast cancer (MBC) * Relapsed with metastatic disease whilst receiving an AI in adjuvant setting * Up to 3 prior lines of endocrine therapy for Advanced Breast Cancer * Up to 1 line of chemotherapy for Advanced Breast Cancer * Patient willing to donate archival tumour sample * Patient willing to donate baseline blood sample * Suitable for further endocrine therapy Exclusion Criteria: * Previous treatment with fulvestrant or PI3K/mTOR(mammalian target of rapamycin )/Akt inhibitor therapy * Treatment with chemotherapy, immunotherapy or targeted, biologic or tumour embolisation within 21 days of study drug administration * Palliative radiotherapy within 7 days of study drug * Clinically significant abnormalities in glucose metabolism * Rapidly progressive visceral disease not suitable for further endocrine therapy * Known brain or leptomeningeal metastases * Any co-existing medical condition precluding trial entry including significant cardiac disease (to be defined in the protocol) * Concomitant medication unsuitable for combination with trial medication

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Conditions

The condition(s) this trial relates to.

breast carcinoma estrogen-receptor positive breast cancer

As listed by the trial registrant

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

Estrogen-receptor-positive breast cancer

Contacts and locations

Locations

  • Blackpool Victoria Hospital

    Blackpool, United Kingdom

  • Calderdale and Huddersfield NHS Foundation Trust

    Huddersfield, United Kingdom

  • Christie Hospital

    Manchester, Greater Manchester, United Kingdom

  • Clatterbridge Cancer Centre

    Bebington, United Kingdom

  • Derriford Hospital

    Plymouth, United Kingdom

  • Glan Clwyd Hospital

    Rhyl, United Kingdom

  • Great Western General Hospital

    Edinburgh, United Kingdom

  • Mount Vernon Cancer Centre

    London, United Kingdom

  • Queen's Hospital

    Romford, United Kingdom

  • Royal Albert and Edward Infirmary -Wrightington

    Wigan, United Kingdom

  • Royal Blackburn Hospital

    Blackburn, United Kingdom

  • Royal Free Hospital

    London, United Kingdom

  • Royal Preston Hospital

    Preston, United Kingdom

  • Royal Stoke University Hospital

    Stoke-on-Trent, United Kingdom

  • Southampton General Hospital

    Southampton, United Kingdom

  • St James's University Hospital

    Leeds, United Kingdom

  • The Ipswich Hospital NHS Trust

    Ipswich, United Kingdom

  • University Hospital of North Durham

    Durham, United Kingdom

  • University Hospitals Morecambe Bay

    Lancaster, United Kingdom

  • Velindre NHS Trust

    Cardiff, Cardiff, United Kingdom

  • Ysbyty Gwynedd

    Bangor, United Kingdom

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