Breast cancer drug showdown: which hormone therapy works better?

NCT ID NCT01602380

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tested two hormone therapies, fulvestrant (Faslodex) and anastrozole (Arimidex), in 462 postmenopausal women with advanced hormone receptor-positive breast cancer who had not received prior hormone treatment. The study compared how long each drug kept the cancer from worsening. Results help doctors choose the best first-line hormone therapy for these patients.

What this could mean

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

Active substance: Fulvestrant (Faslodex) and anastrozole (Arimidex)
What this could lead to: If fulvestrant works better, it could become a new first-choice hormone therapy for postmenopausal women with advanced hormone receptor-positive breast cancer, potentially delaying disease progression.
What could go wrong: This is a completed Phase 3 trial, so results are mature. However, the benefit may be modest, and not all patients respond. Side effects like injection site reactions or joint pain are possible.

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

462 people

The number who actually took part.

Started

Oct 2012

Finished

Jan 2026

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: * Histological confirmation of breast cancer in post menopausal women (age \>=60). Positive hormone receptor status (ER +ve and/or PgR +ve) of primary or metastatic tumour tissue based on local laboratory assessment. * EITHER locally advanced disease (1 line of chemotherapy allowed only if remain unsuitable for therapy of curative intent) OR Metastatic disease. (1 line of chemotherapy for breast cancer allowed only if subsequent evidence of further progressive disease) * At least 1 lesion (measurable and/or non-measurable) that can be accurately assessed at baseline and is suitable for repeated assessment. * Postmenopausal women, fulfilling 1 of: * Prior bilateral oophorectomy * Age \>60 years * Age \< 60 years and amenorrheic for 12+months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and oestradiol in the postmenopausal range Exclusion Criteria: * Presence of life-threatening metastatic disease * Any of: * Extensive hepatic involvement * involving brain or meninges * symptomatic pulmonary lymph spread * Discrete lung metastases are acceptable if respiratory function is not significantly compromised * Prior systemic therapy for breast cancer other than one line of cytotoxic chemotherapy (the last dose of chemotherapy must have been received more than 28 days prior to randomisation) * Radiation therapy if not completed within 28 days prior to randomisation (with the exception of radiotherapy given for control of bone pain, started prior to randomisation). Prior hormonal treatment for breast cancer. * Current or prior malignancy within previous 3 years (other than breast cancer or adequately treated basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Hormone receptor-positive breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

hormone receptor-positive breast cancer neoplasm Neoplasm Metastasis

As listed by the trial registrant

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

Hormone receptor-positive breast cancer

Contacts and locations

Locations

Research Site

Modesto, California, 95355, United States
Research Site

Savannah, Georgia, 31405, United States
Research Site

Auburn, Maine, 04212, United States
Research Site

Worcester, Massachusetts, 01608, United States
Research Site

Detroit, Michigan, 48202, United States
Research Site

St Louis, Missouri, 63110, United States
Research Site

Lincoln, Nebraska, 68506, United States
Research Site

Somerset, New Jersey, 08873, United States
Research Site

Columbus, Ohio, 43202, United States
Research Site

Montgomery, Ohio, 45242, United States
Research Site

Memphis, Tennessee, 38120, United States
Research Site

Salt Lake City, Utah, 84107, United States
Research Site

La Rioja, 5300, Argentina
Research Site

Mar del Plata, B7600CTO, Argentina
Research Site

Pergamino, B2700CPM, Argentina
Research Site

Rosario, S2000KZE, Argentina
Research Site

Porto Alegre, 91350-200, Brazil
Research Site

Santo André, 09060-870, Brazil
Research Site

Abbotsford British Columbia, British Columbia, V2S0C2, Canada
Research Site

Vancouver, British Columbia, V5Z 4E6, Canada
Research Site

Kitchener, Ontario, N2G 1G3, Canada
Research Site

Thunder Bay, Ontario, P7B 6V4, Canada
Research Site

Montreal, Quebec, H3T 1E2, Canada
Research Site

Montreal, Quebec, H4A 3J1, Canada
Research Site

Chengdu, 610041, China
Research Site

Dalian, 116011, China
Research Site

Fuzhou, 350025, China
Research Site

Guangzhou, 510060, China
Research Site

Shanghai, 200032, China
Research Site

Shenyang, 110001, China
Research Site

Suzhou, 215004, China
Research Site

Tianjin, 300060, China
Research Site

Prague, 150 06, Czechia
Research Site

Příbram, 261 01, Czechia
Research Site

Avellino, 83100, Italy
Research Site

Bari, 70124, Italy
Research Site

Benevento, 82100, Italy
Research Site

Catania, 95126, Italy
Research Site

Genova, 16128, Italy
Research Site

Pisa, 56100, Italy
Research Site

Roma, 00100, Italy
Research Site

Roma, 00144, Italy
Research Site

Roma, 00161, Italy
Research Site

Treviglio, 24047, Italy
Research Site

Fukuoka, 811-1395, Japan
Research Site

Hamamatsu, 430-0906, Japan
Research Site

Kagoshima, 892-0833, Japan
Research Site

Kumamoto, 860-8556, Japan
Research Site

Matsuyama, 791-0280, Japan
Research Site

Mitaka-shi, 181-8611, Japan
Research Site

Nishinomiya-shi, 663-8501, Japan
Research Site

Osaka, 540-0006, Japan
Research Site

Sakaishi, 590-0064, Japan
Research Site

Suita-shi, 565-0871, Japan
Research Site

Mexico City, 6760, Mexico
Research Site

Mérida, 97000, Mexico
Research Site

Monterrey, 64000, Mexico
Research Site

Monterrey, 64060, Mexico
Research Site

Monterrey, 64710, Mexico
Research Site

Lima, Lima 18, Peru
Research Site

Lima, LIMA 27, Peru
Research Site

Lima, LIMA 33, Peru
Research Site

Lima, LIMA 41, Peru
Research Site

Katowice, 40-635, Poland
Research Site

Lodz, 90-242, Poland
Research Site

Lublin, 20-718, Poland
Research Site

Brăila, 810325, Romania
Research Site

Craiova, 200347, Romania
Research Site

Onești, 601048, Romania
Research Site

Timișoara, 300239, Romania
Research Site

Barnaul, 656052, Russia
Research Site

Moscow, 115478, Russia
Research Site

Omsk, 644013, Russia
Research Site

Ryazan, 390046, Russia
Research Site

Saint Petersburg, 191014, Russia
Research Site

Saint Petersburg, 195271, Russia
Research Site

Saint Petersburg, 197022, Russia
Research Site

Saint Petersburg, 197758, Russia
Research Site

Tomsk, 634028, Russia
Research Site

Bardejov, 085 01, Slovakia
Research Site

Bratislava, 814 65, Slovakia
Research Site

Bratislava, 833 10, Slovakia
Research Site

Trenčín, 91171, Slovakia
Research Site

Cape Town, 7570, South Africa
Research Site

Cape Town, 7700, South Africa
Research Site

Cape Town, 7925, South Africa
Research Site

Pietermaritzburg, 3201, South Africa
Research Site

Pretoria, 0001, South Africa
Research Site

Pretoria, 0081, South Africa
Research Site

Madrid, 28034, Spain
Research Site

Madrid, 28050, Spain
Research Site

Pamplona, 31008, Spain
Research Site

Pozuelo de Alarcón, 28223, Spain
Research Site

Sabadell, 8208, Spain
Research Site

Seville, 41009, Spain
Research Site

Seville, 41013, Spain
Research Site

Seville, 41014, Spain
Research Site

Valencia, 46014, Spain
Research Site

Valencia, 46026, Spain
Research Site

Taichung, 40447, Taiwan
Research Site

Taipei, 10449, Taiwan
Research Site

Taipei, 112, Taiwan
Research Site

Taipei, 235, Taiwan
Research Site

Ankara, 06100, Turkey (Türkiye)
Research Site

Gaziantep, 27310, Turkey (Türkiye)
Research Site

Cherkasy, 18009, Ukraine
Research Site

Dnipro, 49102, Ukraine
Research Site

Donetsk, 83092, Ukraine
Research Site

Ivano-Frankivsk, 76014, Ukraine
Research Site

Kharkiv Region, 61070, Ukraine
Research Site

Kyiv, 3115, Ukraine
Research Site

Lviv, 79031, Ukraine
Research Site

Mariupol, 87500, Ukraine
Research Site

Uzhhorod, 88000, Ukraine
Research Site

Vinnytsia, 21029, Ukraine
Research Site

Airdrie, ML6 0JS, United Kingdom
Research Site

Derby, DE22 3NE, United Kingdom
Research Site

Stoke-on-Trent, ST4 6QG, United Kingdom

More trials for these conditions

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