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Breast CancerPhase 3NCT00543127

Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

A Phase 3 study testing Fulvestrant and Anastrozole in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 53 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Postmenopausal women with hormone receptor positive and negative Her2 tumours. Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Fulvestrant and Anastrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
870 participants
Where
53 sitesSpain
Study dates
Nov 2007to Jul 2016
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histological documentation of breast cancer.
  • Stage I, II, IIIA and IIIC* invasive breast cancer. One of these two characteristics must be fulfilled:
  • N+
  • T > 1cm *Eligible patients T1-T3 and pN3a (patients with metastasis in infraclavicular nodes would not be eligible)
  • Local treatment with curative intention:
  • mastectomy or tumour excision with free margins + radiotherapy
Show all 16Show fewer
  • axillary lymphadenectomy or sentinel node biopsy
  • Positive hormone receptors (Estrogen Receptor [ER]+ and/or Progesterone Receptor [PR]+) in primary tumour tissue as measured by a central laboratory
  • Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, defined as immunohistochemistry (IHC) 0 or 1+ or negative fluorescence in situ hybridization (FISH) (in the event of IHC 2+ or 3+)
  • Postmenopausal women, defined as women meeting any of the following criteria:
  • Age ≥ 60 years
  • Age ≥ 45 years with amenorrhea ≥ 12 months in the moment of breast cancer diagnosis and an intact uterus
  • Prior bilateral ovariectomy
  • In case previous hysterectomy, follicle stimulating hormone (FSH) and estradiol levels within the postmenopausal range (using local laboratory ranges)* * In patients previously treated with a luteinizing hormone releasing hormone (LH-RH) analogue, the last extended release formulation should have been administered more than 6 months before randomisation, and menses must not have reappeared.
  • A World Health Organization (WHO) performance status of 0, 1, or 2.
  • Age > 18 years

Who cannot join

  • Presence of metastatic disease or bilateral invasive cancer
  • ER and Progesterone Receptor (PR) negative breast cancer
  • HER2-positive breast cancer, defined as FISH+
  • Treatment with a non-approved or experimental drug within 4 months of randomisation
  • Current malignancy or previous malignancy in the past 5 years (other that breast cancer or basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix)
  • Pregnant or nursing patients
Show all 17Show fewer
  • Any of the following laboratory values within 3 months of randomisation:
  • Platelets < 100 x 109/L
  • Total bilirubin > 1.5 x Upper limit of reference range (ULRR)**
  • Patients with documented Gilbert syndrome may be included in this trial
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 2.5 x ULRR
  • A history of:
  • hemorrhagic diathesis (i.e. Disseminated Intravascular Coagulation [DIC], coagulation factor deficiency) or
  • long-term anticoagulant treatment (except for anti-platelet aggregants and low-dose warfarin; see section 3.7)
  • A history of hypersensitivity to the active ingredient or inactive excipients of fulvestrant, aromatase inhibitors, or castor oil
  • Any concomitant severe disease advising against patient participation in the trial o that may jeopardize compliance with the trial protocol, such as uncontrolled heart disease, uncontrolled diabetes mellitus, or uncontrolled severe infections
  • Hormone replacement therapy

Trial locations and contacts

53 sites in 1 country.

53 sites in 1 country

Spain53 sites

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006

  • Centro Oncológico de Galicia

    A Coruña, 15009

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital Universitario Virgen de Los Lirios

    Alcoy, Alicante, 03804

  • Complejo Hospitalario Torrecárdenas

    Almería, 04009

  • Hospital San Agustín de Avilés

    Avilés, Principality of Asturias, 33400

  • Hospital Municipal de Badalona

    Badalona, Barcelona, 08911

  • Hospital Universitari Germans Trias I Pujol

    Badalona, Barcelona, 08916

  • Hospital de Barbastro

    Barbastro, Huesca, 22300

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, 08025

  • Hospital Clinic I Provincial de Barcelona

    Barcelona, 08036

  • Hospital de Basurto

    Bilbao, Vizcaya, 48013

  • Hospital Universitario Puerta Del Mar

    Cadiz, 11009

  • Consorcio Hospitalario Provincial de Castellón

    Castellon, Castellón, 12002

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Donostia

    Donostia / San Sebastian, Guipúzcoa, 20014

  • Onkologikoa

    Donostia / San Sebastian, Guipúzcoa, 20014

  • Hospital Universitario de Valme

    Dos Hermanas, Sevilla, 41700

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital General Universitario de Elda

    Elda, Alicante, 03600

  • HOSPITAL UNIVERSITARI DE GIRONA DR. JOSEP TRUETA (ICO de Girona)

    Girona, 17007

  • Hospital Universitario San Cecilio

    Granada, 18012

  • Hospital General de Granollers

    Granollers, Barcelona, 08402

  • Hospital General Universitario de Guadalajara

    Guadalajara, 19002

  • Hospital Juan Ramón Jiménez

    Huelva, 21005

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Institut Catalá D'Oncología L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Complejo Hospitalario Universitario Insular-Materno Infantil

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, 25198

  • Hospital General Universitario Gregorio Marañón

    Madrid, 28007

  • Hospital Universitario Ramón Y Cajal

    Madrid, 28034

  • Hospital Clínico Universitario San Carlos

    Madrid, 28040

  • CENTRO INTEGRAL ONCOLÓGICO CLARA CAMPAL (Hospital Madrid Norte Sanchinarro)

    Madrid, 28050

  • Hospital Clínico Universitario Virgen de La Victoria

    Málaga, 29010

  • Hospital Regional Universitario Carlos Haya

    Málaga, 29010

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital de Sagunto

    Sagunto, Valencia, 46520

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa CRUZ DE Tenerife, 38320

  • Hospital Universitario Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Del Rocío

    Seville, 41013

  • Hospital Mutua de Terrassa

    Terrassa, Barcelona, 08221

  • Consorci Sanitari de Terrassa

    Terrassa, Barcelona, 08227

  • Hospital Virgen de La Salud

    Toledo, 45004

  • Hospital Usp San Jaime

    Torrevieja, Alicante, 03180

  • Hospital de Torrevieja Salud Ute

    Torrevieja, Alicante, 03186

  • Instituto Valenciano de Oncología

    Valencia, 46009

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Clínico Universitario de Valencia

    Valencia, 46015

  • Hospital Universitario Arnau de Vilanova de Valencia

    Valencia, 46015

  • Hospital Lluís Alcanyis

    Xátiva, Valencia, 46800

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

About this study

Official title: Phase III Trial Comparing Efficacy and Tolerance of Fulvestrant for 3 Years (y) Combined With Anastrozole 5 y Versus Anastrozole 5 y as Adjuvant Hormonotherapy in Postmenopausal With Early Breast Cancer and Positive Hormone Receptors

Postmenopausal women with hormone receptor positive and negative Her2 tumours.

Before randomization, the patients will be stratified according to the center, positive nodes (0 vs. 1-3 vs. ≥4), previous chemotherapy (yes vs no) and hormonal receptors status.

Read the detailed description

It is expected that disease-free survival for patients receiving Anastrozole alone for 5 years will be up to 90%. An increase of 3% in disease-free survival (DFS) is expected in the arm of Fulvestrant plus Anastrozole, i.e a DFS of up to 93%. They will be required 1358 patients per treatment group (i.e, 2716 patients in total) to give 80% power, alfa bilateral 0.05, and OR 0.6888. Assuming 5% screening failures 2852 patients are required to enter the study. In Jun-2010 the recruitment was stopped due to lack of support of the financier based on the result of Faslodex® and Arimidex® in Combination Trial (FACT-trial), comparing Fulvestrant + Anastrozole vs Anastrozole alone in 1st relapse showed no difference in time to progression at more than 40 months follow-up.

Conditions
Breast Cancer
Keywords
luminal, anastrozole, fulvestrant, early breast cancer, HR+/HER2-
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FulvestrantDrug

    Also called Faslodex

    500 mg Im Fulvestrant day 0, 250 mg days 14 and 28(charge dose); later 250 mg each 28 days during 3 years plus 1 mg oral Anastrozole per day during 5 years.

  • AnastrozoleDrug

    Also called Arimidex

    1 mg oral Anastrozole per day during 5 years.

Study groups in NCT00543127
Study groupRoleWhat they receive
Fulvestrant + AnastrozoleExperimentalFulvestrant loading dose regimen will consist of two 5 ml intramuscular injections on day 0 (500 mg), 250 mg single injection on days 14 and 28, and 250 mg single injection every 28 days thereafter for 3 years plus Anastrozole 1 mg PO once daily for 5 years
Receives: Drug: Fulvestrant; Drug: Anastrozole
AnastrozoleActive comparatorAnastrozole 1 mg will be administered orally as one tablet daily for 5 years.
Receives: Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease Free Survival (DFS) Events

    Disease-free survival (DFS) has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

    DFS event is defined as the evidence of local and/or distant recurrence, new primary breast tumour, or death from any cause.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Breast Cancer Specific Survival (BCsS) Events

    BCsS events has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to BCsS in patients treated with anastrozole for 5 years.

    BCsS event is defined as the death from breast cancer.

    Measured: Up to 5 years

  2. Overall Survival (OS) Event

    OS event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

    OS event is defined as the death from any cause.

    Measured: Up to 5 years

  3. Time to Recurrence (TR) Event

    TR event has been evaluated in patients treated with Fulvestrant for 3 years and Anastrozole for 5 years as compared to DFS in patients treated with anastrozole for 5 years.

    TR event is defined as the evidence of breast cancer recurrence (local and/or distant recurrence of breast cancer, does not include second primary malignancies or deaths from any cause).

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionJul 2016
  4. Study completionJul 2016

Why it stopped: Unjustified decision of company that funded the trial.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
870 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00543127
Sponsor's protocol ID
GEICAM/2006-10
Other IDs
2007-003417-14
Status last verified
Mar 2023
First submitted
11 Oct 2007
Last updated
10 Mar 2023
Data monitoring committee
No

Publications

  • Ruiz-Borrego M, Guerrero-Zotano A, Bermejo B, Ramos M, Cruz J, Baena-Canada JM, Cirauqui B, Rodriguez-Lescure A, Alba E, Martinez-Janez N, Munoz M, Antolin S, Alvarez I, Del Barco S, Sevillano E, Chacon JI, Anton A, Escudero MJ, Ruiz V, Carrasco E, Martin M; GEICAM. Phase III evaluating the addition of fulvestrant (F) to anastrozole (A) as adjuvant therapy in postmenopausal women with hormone receptor-positive HER2-negative (HR+/HER2-) early breast cancer (EBC): results from the GEICAM/2006-10 study. Breast Cancer Res Treat. 2019 Aug;177(1):115-125. doi: 10.1007/s10549-019-05296-8. Epub 2019 May 31.

    PubMed 31152327

  • Servitja S, Carrasco E, Andres R, Rodriguez-Lescure A, Martin M, Ruiz-Borrego M, Guerrero A, Bermejo B, Anton A, Munoz M, Margeli M, Alvarez I, Fernandez LA, Ponce J, Cruz J, Martinez P, Lopez-Tarruella S, Amenedo M, Blasco A, Polonio O, Gil-Gil M. Outcomes of Hormone receptor-positive/HER2-negative early breast cancer patients by risk of recurrence groups focusing on the intermediate-risk group: Retrospective analysis from GEICAM studies. Breast Cancer Res. 2026 May 25;28(1):134. doi: 10.1186/s13058-026-02300-0.

    PubMed 42185928

  • Martin M, Carrasco E, Rodriguez-Lescure A, Andres R, Servitja S, Anton A, Ruiz-Borrego M, Bermejo B, Guerrero A, Ramos M, Santaballa A, Munoz M, Cruz J, Lopez-Tarruella S, Chacon JI, Alvarez I, Martinez P, Miralles JJ, Polonio O, Jara C, Aguiar-Bujanda D. Long-term outcomes of high-risk HR-positive and HER2-negative early breast cancer patients from GEICAM adjuvant studies and El Alamo IV registry. Breast Cancer Res Treat. 2023 Sep;201(2):151-159. doi: 10.1007/s10549-023-07002-1. Epub 2023 Jun 20.

    PubMed 37338729

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant and Anastrozole in people with Breast Cancer, run by Spanish Breast Cancer Research Group at 53 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease Free Survival (DFS) Events (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00543127, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.

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