Fulvestrant (Faslodex) + Anastrozole (Arimidex) vs Anastrozole

NCT00543127 | Terminated Phase 3 Results

• 2 other identifiers: GEICAM/2006-102007-003417-14
• Study Type: interventional
• Target: 870
• Locations: 1 country
• Sites: 53

Brief 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.

Conditions

Breast Cancer

Keywords

luminal; anastrozole; fulvestrant; early breast cancer; HR+/HER2-

Outcome Measures

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.

  Up to 5 years

Secondary Outcomes (3)

• Breast Cancer Specific Survival (BCsS) Events

  Up to 5 years

• Overall Survival (OS) Event

  Up to 5 years

• Time to Recurrence (TR) Event

  Up to 5 years

Study Arms (2)

Fulvestrant + Anastrozole

EXPERIMENTAL

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

Anastrozole

ACTIVE COMPARATOR

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

Drug: Anastrozole

Interventions

Fulvestrant DRUG

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

Fulvestrant + Anastrozole

Anastrozole DRUG

1 mg oral Anastrozole per day during 5 years.

Also known as: Arimidex

Anastrozole; Fulvestrant + Anastrozole

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histological documentation of breast cancer.
• Stage I, II, IIIA and IIIC\* invasive breast cancer. One of these two characteristics must be fulfilled:
• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Spanish Breast Cancer Research Group: lead
• AstraZeneca: collaborator

Study Sites (53)

Hospital Universitario Virgen de Los Lirios

Alcoy, Alicante, 03804, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

Location

Hospital General Universitario de Elda

Elda, Alicante, 03600, Spain

Location

Hospital Usp San Jaime

Torrevieja, Alicante, 03180, Spain

Location

Hospital de Torrevieja Salud Ute

Torrevieja, Alicante, 03186, Spain

Location

Hospital Municipal de Badalona

Badalona, Barcelona, 08911, Spain

Location

Hospital Universitari Germans Trias I Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Institut Catalá D'Oncología L'Hospitalet

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Barcelona, 08221, Spain

Location

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Consorcio Hospitalario Provincial de Castellón

Castellon, Castellón, 12002, Spain

Location

Hospital Donostia

Donostia / San Sebastian, Guipúzcoa, 20014, Spain

Location

Onkologikoa

Donostia / San Sebastian, Guipúzcoa, 20014, Spain

Location

Hospital de Barbastro

Barbastro, Huesca, 22300, Spain

Location

Complejo Hospitalario Universitario Insular-Materno Infantil

Las Palmas de Gran Canaria, LAS Palmas, 35016, Spain

Location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, 28922, Spain

Location

Hospital San Agustín de Avilés

Avilés, Principality of Asturias, 33400, Spain

Location

Hospital Universitario de Canarias

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

Location

Hospital Universitario de Valme

Dos Hermanas, Sevilla, 41700, Spain

Location

Hospital de Sagunto

Sagunto, Valencia, 46520, Spain

Location

Hospital Lluís Alcanyis

Xátiva, Valencia, 46800, Spain

Location

Hospital de Basurto

Bilbao, Vizcaya, 48013, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Centro Oncológico de Galicia

A Coruña, 15009, Spain

Location

Complejo Hospitalario Torrecárdenas

Almería, 04009, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

Hospital Clinic I Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario Puerta Del Mar

Cadiz, 11009, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, 14004, Spain

Location

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

Girona, 17007, Spain

Location

Hospital Universitario San Cecilio

Granada, 18012, Spain

Location

Hospital General Universitario de Guadalajara

Guadalajara, 19002, Spain

Location

Hospital Juan Ramón Jiménez

Huelva, 21005, Spain

Location

Complejo Hospitalario de Jaén

Jaén, 23007, Spain

Location

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, 25198, Spain

Location

Hospital General Universitario Gregorio Marañón

Madrid, 28007, Spain

Location

Hospital Universitario Ramón Y Cajal

Madrid, 28034, Spain

Location

Hospital Clínico Universitario San Carlos

Madrid, 28040, Spain

Location

CENTRO INTEGRAL ONCOLÓGICO CLARA CAMPAL (Hospital Madrid Norte Sanchinarro)

Madrid, 28050, Spain

Location

Hospital Clínico Universitario Virgen de La Victoria

Málaga, 29010, Spain

Location

Hospital Regional Universitario Carlos Haya

Málaga, 29010, Spain

Location

Hospital General Universitario Morales Meseguer

Murcia, 30008, Spain

Location

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, 38010, Spain

Location

Hospital Universitario Virgen Del Rocío

Seville, 41013, Spain

Location

Hospital Virgen de La Salud

Toledo, 45004, Spain

Location

Instituto Valenciano de Oncología

Valencia, 46009, Spain

Location

Consorcio Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Clínico Universitario de Valencia

Valencia, 46015, Spain

Location

Hospital Universitario Arnau de Vilanova de Valencia

Valencia, 46015, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (2)

• 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.

  PMID: 31152327 RESULT

• 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.

  PMID: 37338729 DERIVED

Related Links

• Description Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Miguel Martin
• Organization: Department of Medical Oncology, Hospital Universitario Gregorio Marañón

miguel.martin@salud.madrid.org

Study Officials

• Study Director

  Hospital General Universitario Gregorio Marañón

  STUDY DIRECTOR

• Study Director

  Centro Oncológico de Galicia

  STUDY DIRECTOR

• Study Director

  Hospitales Universitarios Virgen del Rocío

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2007
• First Posted: October 12, 2007
• Study Start: November 1, 2007
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: March 10, 2023
• Results First Posted: April 5, 2019

Record last verified: 2023-03

Locations

ES (53)