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TerminatedNCT00543127Updated Mar 10, 2023Results posted

Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

A Phase 3 interventional study of Fulvestrant and Anastrozole in Breast Cancer, sponsored by Spanish Breast Cancer Research Group. Terminated at 53 sites in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-10.

Sponsored by Spanish Breast Cancer Research Group · Phase 3, Interventional, and Treatment

Why this study was terminated
Unjustified decision of company that funded the trial.
Phase
Phase 3
Study type
Interventional
Enrollment
870
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • luminal
  • anastrozole
  • fulvestrant
  • early breast cancer
  • HR+/HER2-
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 870 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Spanish Breast Cancer Research Group is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Histological documentation of breast cancer.

  2. 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)

  3. Local treatment with curative intention:

    • mastectomy or tumour excision with free margins + radiotherapy
    • axillary lymphadenectomy or sentinel node biopsy
  4. Positive hormone receptors (Estrogen Receptor [ER]+ and/or Progesterone Receptor [PR]+) in primary tumour tissue as measured by a central laboratory
  5. 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+)

  6. 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.
  7. A World Health Organization (WHO) performance status of 0, 1, or 2.
  8. Age > 18 years

Exclusion criteria

Exclusion criteria:

  1. Presence of metastatic disease or bilateral invasive cancer
  2. ER and Progesterone Receptor (PR) negative breast cancer
  3. HER2-positive breast cancer, defined as FISH+
  4. Treatment with a non-approved or experimental drug within 4 months of randomisation
  5. 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)
  6. Pregnant or nursing patients

  7. 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)
  8. A history of hypersensitivity to the active ingredient or inactive excipients of fulvestrant, aromatase inhibitors, or castor oil
  9. 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
  10. Hormone replacement therapy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
870 participants (actual)

Study arms

  • Experimental
    Fulvestrant + Anastrozole

    Fulvestrant 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

    Drug: Fulvestrant · Drug: Anastrozole

  • Active comparator
    Anastrozole

    Anastrozole 1 mg will be administered orally as one tablet daily for 5 years.

    Drug: Anastrozole

Interventions

  • DrugFulvestrant

    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.

    Also known as: Faslodex

  • DrugAnastrozole

    1 mg oral Anastrozole per day during 5 years.

    Also known as: Arimidex

06

What researchers measure

Primary outcomes

  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.

    Time frame: Up to 5 years

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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).

    Time frame: Up to 5 years

07

Results

Posted Apr 5, 2019

Participant flow

870 patients were recruited, from them, 437 were randomized to Anastrozole (A) and 433 to A plus Fulvestrant (F), but 18 patients (3 in A arm and 15 in arm A+F) never received treatment.

Participant flow — Overall Study
MilestoneFulvestrant + AnastrozoleAnastrozole
Started433437
Completed303350
Not completed13087

Outcome measures

PrimaryDisease 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.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Disease Free Survival (DFS) Events
ParticipantsFulvestrant + AnastrozoleAnastrozole
Disease Free Survival (DFS) Events4962
SecondaryBreast 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.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Breast Cancer Specific Survival (BCsS) Events
ParticipantsFulvestrant + AnastrozoleAnastrozole
Breast Cancer Specific Survival (BCsS) Events1718
SecondaryOverall 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.

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Overall Survival (OS) Event
ParticipantsFulvestrant + AnastrozoleAnastrozole
Overall Survival (OS) Event2834
SecondaryTime 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).

Time frame:
Up to 5 years
Reported as:
Count of participants · Participants
Time to Recurrence (TR) Event
ParticipantsFulvestrant + AnastrozoleAnastrozole
Time to Recurrence (TR) Event3646

Adverse events

Collected over Non-serious Adverse Events (AEs) and Serious Adverse Events (SAEs) will be recorded from the date informed consent is signed, during the treatment period, and for up to 8 weeks after the last injection in patients randomised to fulvestrant if this patient does not continue with anastrozole, or up to 30 days after the last tablet when this is the last study treatment received by the patient.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fulvestrant + Anastrozole—40/415 (9.6%)192/415 (46.3%)
Anastrozole—61/437 (14%)197/437 (45.1%)
Most frequent serious events
Showing 10 of 87
Most frequent serious events
EventFulvestrant + AnastrozoleAnastrozole
FractureMusculoskeletal and connective tissue disorders3/4155/437
CNS cerebrovascular ischemiaNervous system disorders1/4154/437
Colon cancerGastrointestinal disorders3/4153/437
Infection with normal ANC or grade 1 or 2 neutrophils - pulmonary/upper respiratory lung (pneumonia)Infections and infestations3/4150/437
cholelithiasisHepatobiliary disorders1/4153/437
Thrombosis/embolism (vascular access-related)Vascular disorders0/4153/437
Cardiac ischemia/infarctionCardiac disorders2/4151/437
goitreEndocrine disorders2/4150/437
CholecystitisHepatobiliary disorders2/4151/437
Valvular heart diseaseCardiac disorders0/4152/437
Most frequent other events
Most frequent other events
EventFulvestrant + AnastrozoleAnastrozole
Musculoskeletal joint painMusculoskeletal and connective tissue disorders83/41581/437
HypertensionCardiac disorders41/41558/437
Fatigue (asthenia, lethargy, malaise)General disorders49/41523/437
Weight gainGeneral disorders39/41531/437
Musculoskeletal bone painMusculoskeletal and connective tissue disorders39/41534/437
Weight lossGeneral disorders37/41541/437
LDL-cholesterol highMetabolism and nutrition disorders22/41541/437
Hot flashes/flushesEndocrine disorders23/41518/437
Cholesterol, serum-high (hypercholesterolemia)Metabolism and nutrition disorders21/41523/437

Baseline characteristics

Age, Continuous
Age, Continuous(years)Fulvestrant + AnastrozoleAnastrozoleTotal
Median62 (40 to 86)62 (44 to 86)62 (40 to 86)
Sex: Female, Male
Sex: Female, Male(Participants)Fulvestrant + AnastrozoleAnastrozoleTotal
Female433437870
Male000
Breast Surgery
Breast Surgery(Participants)Fulvestrant + AnastrozoleAnastrozoleTotal
Conservative303310613
Mastectomy130127257
Axillary surgery
Axillary surgery(Participants)Fulvestrant + AnastrozoleAnastrozoleTotal
Axillary dissection258281539
Sentinel Node Biopsy174155329
Unknown112
Previous chemotherapy
Previous chemotherapy(Participants)Fulvestrant + AnastrozoleAnastrozoleTotal
Adjuvant256261517
Neoadjuvant373471
Neoadjuvant + Adjuvant325
None137140277
Previous radiotherapy
Previous radiotherapy(Participants)Fulvestrant + AnastrozoleAnastrozoleTotal
YES348347695
NO8590175
Histopathologic type
Histopathologic type(Participants)Fulvestrant + AnastrozoleAnastrozoleTotal
Invasive Ductal Carcinoma337346683
Invasive Lobular Carcinoma7171142
Other252045
Histologic grade
Histologic grade(Participants)Fulvestrant + AnastrozoleAnastrozoleTotal
Grade 18882170
Grade 2216235451
Grade 39483177
Grade X353772

3 further baseline measures are reported on the registry.

08

Study locations

53 sites
  • Hospital Universitario Virgen de Los Lirios
    Alcoy, Alicante 03804, Spain
  • Hospital General Universitario de Elche
    Elche, Alicante 03203, Spain
  • Hospital General Universitario de Elda
    Elda, Alicante 03600, Spain
  • Hospital Usp San Jaime
    Torrevieja, Alicante 03180, Spain
  • Hospital de Torrevieja Salud Ute
    Torrevieja, Alicante 03186, Spain
  • Hospital San Agustín de Avilés
    Avilés, Asturias 33400, Spain
  • Hospital Municipal de Badalona
    Badalona, Barcelona 08911, Spain
  • Hospital Universitari Germans Trias I Pujol
    Badalona, Barcelona 08916, Spain
  • Hospital General de Granollers
    Granollers, Barcelona 08402, Spain
  • Institut Catalá D'Oncología L'Hospitalet
    L'hospitalet de Llobregat, Barcelona 08907, Spain
  • Corporació Sanitaria Parc Taulí
    Sabadell, Barcelona 08208, Spain
  • Hospital Mutua de Terrassa
    Terrassa, Barcelona 08221, Spain
  • Consorci Sanitari de Terrassa
    Terrassa, Barcelona 08227, Spain
  • Hospital Universitario Marqués de Valdecilla
    Santander, Cantabria 39008, Spain
  • Consorcio Hospitalario Provincial de Castellón
    Castellón de La Plana, Castellón 12002, Spain
  • Hospital Donostia
    Donostia-san Sebastián, Guipúzcoa 20014, Spain
  • Onkologikoa
    Donostia-san Sebastián, Guipúzcoa 20014, Spain
  • Hospital de Barbastro
    Barbastro, Huesca 22300, Spain
  • Complejo Hospitalario Universitario Insular-Materno Infantil
    Las Palmas de Gran Canaria, LAS Palmas 35016, Spain
  • Hospital Universitario Fundación Alcorcón
    Alcorcón, Madrid 28922, Spain
  • Hospital Universitario de Canarias
    La Laguna, Santa CRUZ DE Tenerife 38320, Spain
  • Hospital Universitario de Valme
    Dos Hermanas, Sevilla 41700, Spain
  • Hospital de Sagunto
    Sagunto, Valencia 46520, Spain
  • Hospital Lluís Alcanyis
    Xátiva, Valencia 46800, Spain
  • Hospital de Basurto
    Bilbao, Vizcaya 48013, Spain
  • Complejo Hospitalario Universitario A Coruña
    A Coruña, 15006, Spain
  • Centro Oncológico de Galicia
    A Coruña, 15009, Spain
  • Complejo Hospitalario Torrecárdenas
    Almería, 04009, Spain
  • Hospital de La Santa Creu I Sant Pau
    Barcelona, 08025, Spain
  • Hospital Clinic I Provincial de Barcelona
    Barcelona, 08036, Spain
  • Hospital Universitario Puerta Del Mar
    Cadiz, 11009, Spain
  • Hospital Universitario Reina Sofía
    Córdoba, 14004, Spain
  • HOSPITAL UNIVERSITARI DE GIRONA DR. JOSEP TRUETA (ICO de Girona)
    Girona, 17007, Spain
  • Hospital Universitario San Cecilio
    Granada, 18012, Spain
  • Hospital General Universitario de Guadalajara
    Guadalajara, 19002, Spain
  • Hospital Juan Ramón Jiménez
    Huelva, 21005, Spain
  • Complejo Hospitalario de Jaén
    Jaén, 23007, Spain
  • Hospital Universitario Arnau de Vilanova de Lleida
    Lleida, 25198, Spain
  • Hospital General Universitario Gregorio Marañón
    Madrid, 28007, Spain
  • Hospital Universitario Ramón Y Cajal
    Madrid, 28034, Spain
  • Hospital Clínico Universitario San Carlos
    Madrid, 28040, Spain
  • CENTRO INTEGRAL ONCOLÓGICO CLARA CAMPAL (Hospital Madrid Norte Sanchinarro)
    Madrid, 28050, Spain
  • Hospital Clínico Universitario Virgen de La Victoria
    Malaga, 29010, Spain
  • Hospital Regional Universitario Carlos Haya
    Malaga, 29010, Spain
  • Hospital General Universitario Morales Meseguer
    Murcia, 30008, Spain
  • Hospital Universitario Nuestra Señora de Candelaria
    Santa Cruz de Tenerife, 38010, Spain
  • Hospital Universitario Virgen Del Rocío
    Sevilla, 41013, Spain
  • Hospital Virgen de La Salud
    Toledo, 45004, Spain
  • Instituto Valenciano de Oncología
    Valencia, 46009, Spain
  • Consorcio Hospital General Universitario de Valencia
    Valencia, 46014, Spain
  • Hospital Clínico Universitario de Valencia
    Valencia, 46015, Spain
  • Hospital Universitario Arnau de Vilanova de Valencia
    Valencia, 46015, Spain
  • Hospital Universitario Miguel Servet
    Zaragoza, 50009, Spain
09

References and documents

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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00543127
Lead sponsor
Spanish Breast Cancer Research Group
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Oct 12, 2007
Start date
Nov 2007
Primary completion
Jul 2016
Completion
Jul 2016
Results posted
Apr 5, 2019
Last update
Mar 10, 2023

Study contacts

Study Director
study director · Hospital General Universitario Gregorio Marañón
Study Director
study director · Centro Oncológico de Galicia
Study Director
study director · Hospitales Universitarios Virgen del Rocío

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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