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New pill shows promise in slowing advanced breast cancer

NCT ID NCT04214288

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

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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 Results may not be published yet.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
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tested a new oral drug, AZD9833, against a standard injected treatment (fulvestrant) in 240 women with advanced ER-positive, HER2-negative breast cancer. The main goal was to see how long the cancer stayed under control. Results from one dose group were limited because it was stopped early. This is a disease-control study, not a cure, as patients continue to need ongoing treatment.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

240 people

The number who actually took part.

Started

Apr 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 to 130 years

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 female patients aged at least 18 years. * Metastatic or loco-regionally recurrent ER-positive HER2-negative adenocarcinoma of the breast. * Radiological or other objective evidence of progression on or after the last systemic therapy prior to starting study treatment. * Patients must have at least 1 lesion, not previously irradiated, that can be measured accurately at baseline as ≥10 mm in the longest diameter or in absence of measurable disease as defined above, at least 1 lytic or mixed (lytic+sclerotic) bone lesion. * Eastern Cooperative Oncology Group (ECOG)/World Health Organisation (WHO) performance status 0 to 1. * Prior endocrine therapy as follows: 1. Recurrence or progression on at least one line of endocrine therapy 2. No more than 1 line of endocrine therapy for advanced disease 3. No more than 1 line of chemotherapy for advanced disease 4. Prior treatment with CDK4/6 inhibitors is permitted 5. No prior treatment with fulvestrant, oral selective oestrogen receptor degrader (SERD), or related therapies * Inclusion criterion for the paired tumour biopsy research subgroup: Washout from prior tamoxifen: 4 months to elapse from last tamoxifen dose to pre-dose on-study biopsy. Exclusion Criteria: Intervention with any of the following: * Any cytotoxic chemotherapy, investigational agents or other anti-cancer drugs for the treatment of breast cancer from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment. * Use of systemic oestrogen-containing hormone replacement therapy within 6 months prior to the first dose of study treatment. * Medications or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4/5 and sensitive CYP2B6 substrates, and drugs which are substrates of CYP2C9 and/or CYP2C19 which have a narrow therapeutic index or inability to stop use within the washout period prior to receiving the first dose of study treatment. * Drugs that are known to prolong QT and have a known risk of torsades de pointes. * The following cardiovascular criteria: QTcF \>470 ms, resting heart rate \<45 bpm, clinically significant abnormalities of resting electrocardiogram, uncontrolled hypertension, symptomatic hypotension, factors that increase the risk for QTc prolongation, left ventricular ejection fraction \<50%. * Radiotherapy with a limited field of radiation for palliation within 1 week of dosing, or to \> 30% of bone marrow or a wide field within 4 weeks of dosing. * Major surgical procedure or significant traumatic injury. * Presence of life-threatening metastatic visceral disease or uncontrolled central nervous system metastatic disease. * Inadequate bone marrow reserve or organ function. * Refractory nausea and vomiting, uncontrolled chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of AZD9833. * History of hypersensitivity to active or inactive excipients of AZD9833 or fulvestrant. * Previous randomisation in the present study. * Women of childbearing potential.

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Conditions

The condition(s) this trial relates to.

estrogen-receptor positive breast cancer hormone receptor-positive breast cancer Neoplasm Metastasis

As listed by the trial registrant

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

Advanced ER-positive HER2-negative breast cancer

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35205, United States

  • Research Site

    Long Beach, California, 90806, United States

  • Research Site

    Fort Myers, Florida, 33901, United States

  • Research Site

    St. Petersburg, Florida, 33705, United States

  • Research Site

    Lincoln, Nebraska, 68506, United States

  • Research Site

    Canton, Ohio, 44710, United States

  • Research Site

    Chattanooga, Tennessee, 37404, United States

  • Research Site

    Nashville, Tennessee, 37203, United States

  • Research Site

    Eagle River, Wisconsin, 54521, United States

  • Research Site

    Brasschaat, 2930, Belgium

  • Research Site

    Charleroi, 6000, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Haine-Saint-Paul, 7100, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Libramont-Chevigny, 6800, Belgium

  • Research Site

    Namur, 5000, Belgium

  • Research Site

    Greenfield Park, Quebec, J4V 2H1, Canada

  • Research Site

    Montreal, Quebec, H1T 2M4, Canada

  • Research Site

    Montreal, Quebec, H3T 1E2, Canada

  • Research Site

    Paris, 75005, France

  • Research Site

    Vandœuvre-lès-Nancy, 54519, France

  • Research Site

    Batumi, 6000, Georgia

  • Research Site

    Tbilisi, '0112, Georgia

  • Research Site

    Tbilisi, '0159, Georgia

  • Research Site

    Tbilisi, '0186, Georgia

  • Research Site

    Tbilisi, 0159, Georgia

  • Research Site

    Tbilisi, 0186, Georgia

  • Research Site

    Berlin, 10707, Germany

  • Research Site

    Düsseldorf, 40225, Germany

  • Research Site

    Essen, 45136, Germany

  • Research Site

    Budapest, 1122, Hungary

  • Research Site

    Debrecen, 4032, Hungary

  • Research Site

    Kaposvár, 7400, Hungary

  • Research Site

    Kecskemét, 6000, Hungary

  • Research Site

    Nyíregyháza, 4400, Hungary

  • Research Site

    Pécs, 7624, Hungary

  • Research Site

    Szeged, 6725, Hungary

  • Research Site

    Jerusalem, 91031, Israel

  • Research Site

    Jerusalem, 9112001, Israel

  • Research Site

    Nahariya, 22100, Israel

  • Research Site

    Petah Tikva, 4941492, Israel

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Catanzaro, 88100, Italy

  • Research Site

    Meldola, 47014, Italy

  • Research Site

    Messina, 98158, Italy

  • Research Site

    Milan, 20141, Italy

  • Research Site

    Milan, 20121, Italy

  • Research Site

    Monza, 20900, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Roma, 00128, Italy

  • Research Site

    Umbria, 5100, Italy

  • Research Site

    Bydgoszcz, 85-796, Poland

  • Research Site

    Lodz, 93-513, Poland

  • Research Site

    Piła, 64-920, Poland

  • Research Site

    Rzeszów, 35-021, Poland

  • Research Site

    Skorzewo, 60-185, Poland

  • Research Site

    Warsaw, 02-781, Poland

  • Research Site

    Almada, 2805-267, Portugal

  • Research Site

    Lisbon, 1400-038, Portugal

  • Research Site

    Lisbon, 1449-005, Portugal

  • Research Site

    Lisbon, 1998-018, Portugal

  • Research Site

    Kazan', 420029, Russia

  • Research Site

    Krasnodar, 350040, Russia

  • Research Site

    Kursk, 305035, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 123056, Russia

  • Research Site

    Pyatigorsk, 357502, Russia

  • Research Site

    Ryazan, 390011, Russia

  • Research Site

    Saint Petersburg, 197082, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Volgograd, 400138, Russia

  • Research Site

    Goyang-si, 10408, South Korea

  • Research Site

    Incheon, 405-760, South Korea

  • Research Site

    Barcelona, 08190, Spain

  • Research Site

    Madrid, 28050, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Zaragoza, 50009, Spain

  • Research Site

    Cherkasy, 18009, Ukraine

  • Research Site

    Chernivtsі, 58013, Ukraine

  • Research Site

    Kyiv, 03039, Ukraine

  • Research Site

    M. Kyiv, 02094, Ukraine

  • Research Site

    S. Khodosivka, 08173, Ukraine

  • Research Site

    Uzhhorod, 88000, Ukraine

  • Research Site

    Derby, DE22 3NE, United Kingdom

  • Research Site

    Leicester, LE1 5WW, United Kingdom