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Higher dose of breast cancer drug shows promise in Late-Stage trial

NCT ID NCT00099437

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 2 times

Summary

This study tested whether a higher dose (500 mg) of the drug fulvestrant works better than the standard dose (250 mg) in postmenopausal women with a certain type of advanced breast cancer that had worsened after previous hormone therapy. The trial involved 736 participants and measured how long it took for the cancer to progress. The goal was to improve disease control without a cure, as ongoing treatment is needed.

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

736 people

The number who actually took part.

Started

Feb 2005

Expected to finish

Dec 2026

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

45 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: * Breast Cancer has continued to grow after having received treatment with an anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor * Requiring hormonal treatment * Postmenopausal women defined as a woman who has stopped having menstrual periods * Evidence of positive estrogen receptor hormone sensitivity * Written informed consent to participate in the trial Exclusion Criteria: * Treatment with an investigational or non-approved drug within one month * An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures * A history of allergies to any active or inactive ingredients of Faslodex (i.e. castor oil) * Treatment with more than one regimen of chemotherapy for advanced breast cancer * Treatment with more than one regimen of hormonal treatment for advanced breast cancer

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm estrogen-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

  • Research Site

    Casa Grande, Arizona, 85122, United States

  • Research Site

    Fountain Valley, California, 92708, United States

  • Research Site

    New Britain, Connecticut, 06052, United States

  • Research Site

    Crystal River, Florida, 34429, United States

  • Research Site

    Fort Lauderdale, Florida, 33308, United States

  • Research Site

    Urbana, Illinois, 61801, United States

  • Research Site

    Rosedale, Maryland, 21237, United States

  • Research Site

    Detroit, Michigan, 48202, United States

  • Research Site

    Kansas City, Missouri, 64131, United States

  • Research Site

    St Louis, Missouri, 63141, United States

  • Research Site

    Voorhees Township, New Jersey, 08043, United States

  • Research Site

    Greenville, North Carolina, 27858, United States

  • Research Site

    Pasadena, Texas, 77504, United States

  • Research Site

    West Bend, Wisconsin, 53095, United States

  • Research Site

    Brasschaat, 2930, Belgium

  • Research Site

    Brussels, 1070, Belgium

  • Research Site

    Brussels, 1090, Belgium

  • Research Site

    Edegem, 2650, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Hasselt, 3500, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Turnhout, 2300, Belgium

  • Research Site

    Barretos, 14784-400, Brazil

  • Research Site

    Londrina, 86010-640, Brazil

  • Research Site

    Porto Alegre, 91350-200, Brazil

  • Research Site

    Recife, 50670-420, Brazil

  • Research Site

    Salvador, 40170-070, Brazil

  • Research Site

    São Paulo, 04039-001, Brazil

  • Research Site

    Antofagasta, 1240000, Chile

  • Research Site

    Santiago, 8380455, Chile

  • Research Site

    Santiago, Chile

  • Research Site

    Bogotá, Colombia

  • Research Site

    Cali, Colombia

  • Research Site

    Brno, 656 53, Czechia

  • Research Site

    České Budějovice, 370 87, Czechia

  • Research Site

    Pardubice, 520 03, Czechia

  • Research Site

    Prague, 100 34, Czechia

  • Research Site

    Prague, 128 08, Czechia

  • Research Site

    Prague, 180 00, Czechia

  • Research Site

    Tábor, 390 03, Czechia

  • Research Site

    V Uvalu 84, 150 06, Czechia

  • Research Site

    Nyíregyháza, 4400, Hungary

  • Research Site

    Székesfehérvár, 8000, Hungary

  • Research Site

    Szombathely, 9700, Hungary

  • Research Site

    Ansārinagar, 110 029, India

  • Research Site

    Bhopal, 462001, India

  • Research Site

    Hyderabad, 500082, India

  • Research Site

    Jaipur, 302013, India

  • Research Site

    Kolkata, 700054, India

  • Research Site

    Manipal, 576 104, India

  • Research Site

    Marg Jaipur, 302004, India

  • Research Site

    Mumbai, 400012, India

  • Research Site

    Pune, 411001, India

  • Research Site

    Trivandrum, 2417, India

  • Research Site

    Vellore, 632004, India

  • Research Site

    Aviano, 33081, Italy

  • Research Site

    Bergamo, 24128, Italy

  • Research Site

    Carpi, 41012, Italy

  • Research Site

    Genova, 16132, Italy

  • Research Site

    Prato, 59100, Italy

  • Research Site

    Reggio Emilia, 42100, Italy

  • Research Site

    Varese, 21100, Italy

  • Research Site

    Floriana, VLT 14, Malta

  • Research Site

    Mexico City, 06720, Mexico

  • Research Site

    México, 01090, Mexico

  • Research Site

    México, 14140, Mexico

  • Research Site

    Bialystok, 15-027, Poland

  • Research Site

    Lodz, 90-553, Poland

  • Research Site

    Poznan, 61-878, Poland

  • Research Site

    Ivanovo, 153040, Russia

  • Research Site

    Kazan, Tatarstan, 420029, Russia

  • Research Site

    Kazan, Tatarstan, 420111, Russia

  • Research Site

    Krasnodar, 350040, Russia

  • Research Site

    Lipetsk, 398005, Russia

  • Research Site

    Moscow, 107005, Russia

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Moscow, 121356, Russia

  • Research Site

    Moscow, 59401, Russia

  • Research Site

    Nizhny Novgorod, 603081, Russia

  • Research Site

    Obninsk, 249020, Russia

  • Research Site

    Ryazan, 390046, Russia

  • Research Site

    Saint Petersburg, 191014, Russia

  • Research Site

    Saint Petersburg, 197089, Russia

  • Research Site

    Saint Petersburg, 197758, Russia

  • Research Site

    Yaroslavl, 150054, Russia

  • Research Site

    Bardejov, 08501, Slovakia

  • Research Site

    Bratislava, 812 50, Slovakia

  • Research Site

    Nitra, 949 01, Slovakia

  • Research Site

    Trnava, 917 75, Slovakia

  • Research Site

    A Coruña, 15006, Spain

  • Research Site

    Madrid, 28040, Spain

  • Research Site

    Málaga, 29010, Spain

  • Research Site

    Oviedo, 33011, Spain

  • Research Site

    Salamanca, 37007, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Cherkasy, 18009, Ukraine

  • Research Site

    Dnipro, 49102, Ukraine

  • Research Site

    Donetsk, 83092, Ukraine

  • Research Site

    Kyiv, 03022, Ukraine

  • Research Site

    Lviv, 79031, Ukraine

  • Research Site

    Sumy, 40022, Ukraine

  • Research Site

    Ternopil, 46023, Ukraine

  • Research Site

    Uzhhorod, 88000, Ukraine

  • Research Site

    Caracas, 1010, Venezuela

  • Research Site

    Caracas, 1053, Venezuela

  • Research Site

    Caracas, 1060, Venezuela

More trials for these conditions

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