Fulvestrant (Faslodex) + Anastrozol (Arimidex) vs Anastrozol - Full Text View

Sponsors and Collaborators:	Spanish Breast Cancer Research Group AstraZeneca
Information provided by:	Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:	NCT00543127

Purpose

Postmenopausal women with hormone receptor positive and negative Her2 tumours.

Estimation of the 5-year disease-free survival in the control arm is 80%. The experimental arm is expected to increase the 5-year disease-free survival by 4% (up to 84%). With an alpha error of 0.05 and 80% power, 1445 patients per arm are needed. Assuming a 10% post-randomization drop-out, 3180 patients in total are needed.

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.

Condition	Intervention	Phase
Breast Cancer	Drug: fulvestrant + anostrozol Drug: Anastrozol	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole Ici 182780

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Multicentral, Phase III Study of Parallel Groups to Compare the Efficiency and Tolerance of Fulvestrant Administered for Three Years in Combination With Anastrozol for 5 Years Versus Anastrozol for 5 Years as Adjuvant Hormonotherapy in Postmenopausal Women With Early Breast Cancer and + HRs.

Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:

To compare free disease survival of patients treated with Fulvestrant for 3 years and anastrozol for 5 years versus free disease survival of patients treated with anastrozol for 5 years. [ Time Frame: 5 years ]

Secondary Outcome Measures:

To compare breast cancer specific survival between both arms of treatment. To compare overall survival between both arms of treatment. To compare safety profile and tolerance between both arms od treatment [ Time Frame: 5 years ]

Estimated Enrollment:	3180
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2015

Arms	Assigned Interventions
1: Experimental Fulvestrant charge dose days 0,14, 28 (250 mg) and later each 28 days concomitant with anastrozol (1 mg daily) for the three first years followed by 2 years with anastrozol (1mg daily)alone.	Drug: fulvestrant + anostrozol
2: Active Comparator Anastrozol 1 mg daily for 5 yeras.	Drug: Anastrozol

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Written signed informed consent.
Breast cancer histologically confirmed.
Stages I, II, IIIA of invasive breast cancer. Patients must comply with one of the following characteristics: N+, T > 2 cm.
Mastectomy or lumpectomy with free margins + radiotherapy, axilar node dissection or centinel node dissection.
Positive hormonal receptors (ER+ and/or PgR+) determined at a central laboratory.
Negative HER2 (defined as IHQ 0 or 1+ or negative FISH when IHQ 2+ or 3+).
Postmenopausal women (woman complies with one of the following criteria: age ≥ 60 years, age ≥ 45 years and amenorrhea, amenorrhea ≥ 12 months and undamaged uterus, bilateral ovariectomy, FSH and estradiol level into postmenopausal range (using local ranges).
ECOG = 0, 1 or 2.
Age > 18 years.

Exclusion Criteria:

Metastatic disease or invasive bilateral breast cancer.
Negative ER and PgR breast cancer.
Treatment with a not approved or experimental drug within 4 weeks before randomization.
Current or previous malignant process within the last 5 years (different from breast cancer or basocelular carcinoma or escamocelular of the skin or cervix carcinoma in situ).
Pregnant or lactating women. 6. Concurrent hormone replacement therapy and other hormonal agents (raloxifen, tamoxifen,etc.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543127

Contacts

Contact: Miguel Martín Jiménez, MD., PhD.	0034913303000	mmartin@geicam.org
Contact: Manuel Ramos Vázquez, MD., PhD.	0034981 287499	omedica@cog.es

Locations

Spain, Madrid
Spanish Breast Cancer Research Group (GEICAM)	Recruiting
San Sebastián de los Reyes, Madrid, Spain, 28700
Contact: María Dolores Briones, PhD +34916592870 lbriones@geicam.org
Principal Investigator: Monserrat Muñoz
Principal Investigator: Miguel A Seguí
Principal Investigator: Carlos Jara
Principal Investigator: Angels Arcusa
Principal Investigator: Jose I. Chacon, MD
Principal Investigator: José I Mayordomo
Principal Investigator: Pedro Sánchez-Rovira
Principal Investigator: Miguel Martín
Principal Investigator: Manuel Ramos
Principal Investigator: Ana Lluch
Principal Investigator: Laura G-Estévez
Principal Investigator: Javier Cassinello, MD., PhD.
Principal Investigator: Lourdes Calvo
Principal Investigator: Angel Guerrero, MD., PhD
Principal Investigator: Juan Carlos Toral, MD., PhD.
Principal Investigator: Manuel Ruiz Borrego, MD, PhD
Principal Investigator: Jose Manuel Baena, MD, PhD
Principal Investigator: Beatriz Cirauqui, MD, PhD
Principal Investigator: Elena Garcia, MD, PhD
Principal Investigator: Alvaro Rodriguez Lescure, MD, PhD
Principal Investigator: Josefina Cruz, MD, PhD
Principal Investigator: Sonia Del Barco, MD, PhD
Principal Investigator: Juan De la Haba, MD, PhD
Principal Investigator: Sonia Gonzalez, MD, PhD
Principal Investigator: Javier Salvador, MD, PhD
Principal Investigator: Laura Jolis, MD, PhD
Principal Investigator: Antonio Anton, MD, PhD
Principal Investigator: Agustin Barnadas, MD, PhD
Principal Investigator: Arrate Plazaola, MD, PhD
Principal Investigator: Isabel Alvarez, MD, PhD
Principal Investigator: Eduardo Martinez de Dueñas, MD, PhD
Principal Investigator: Jesus Florian, MD, PhD

Sponsors and Collaborators

Spanish Breast Cancer Research Group

AstraZeneca

Investigators

Study Chair:	Miguel Martín Jiménez, MD., PhD.	Hospital Clínico San Carlos
Study Chair:	Manuel Ramos Vázquez, MD., PhD.	Centro Oncológico de Galicia
Study Chair:	Manuel Ruiz Borrego, MD., PhD.	Hospital Virgen del Rocío
Principal Investigator:	Alberto Moreno, MD. PhD.	Hospital de Jerez
Principal Investigator:	José Manuel Baena Cañada, MD., PhD.	Hospital Puerta del Mar
Principal Investigator:	Silvia Antolín, MD., PhD	Complejo Hospitalario Juan Canalejo
Principal Investigator:	José Luis Alonso Romero, MD., PhD	Hospital Virgen de la Arrixaca
Principal Investigator:	Angels Arcusa Lanza, MD. PhD	Consorci Sanitari de Terrasa
Principal Investigator:	Isabel Moreno, MD., PhD.	Hospital Municipal de Badalona
Principal Investigator:	Isabel Álvarez, MD. PhD.	Hospital de Donostia
Principal Investigator:	Juan Carlos Toral, MD., PhD	Hospital de Torrevieja
Principal Investigator:	Isabel Calvo, MD., PhD	Hospital Madrid Norte Sanchinarro
Principal Investigator:	Pedro Sanchez Rovira, MD. PhD.	Complejo Hospitalario de Jaén
Principal Investigator:	Javier Salvador Bofill, MD., PhD.	Hospital de Valme
Principal Investigator:	Francisco Carabantes, MD., PhD	Hospital Carlos Haya
Principal Investigator:	Emilio Alba, MD., PhD	Hospital Virgen de la Victoria
Principal Investigator:	Juan Bayo, MD., PhD.	Hospital Juan Ramón Jiménez
Principal Investigator:	Jesús Florián, MD., PhD.	Hospital Comarcal de Barbastro
Principal Investigator:	Antonio Antón, MD., PhD.	Hospital Miguel Servet
Principal Investigator:	José Ignacio Mayordomo, MD., PhD.	Hospital Clinico Lozano Blesa
Principal Investigator:	Ignacio Pelaez, MD., PhD.	Hospital de Cabueñes
Principal Investigator:	Montserrat Muñoz, MD., PhD	Hospital Clinic i Provincial de Barcelona
Principal Investigator:	Sonia González, MD., PhD.	Hospital Mutua de Terrassa
Principal Investigator:	Ana Lluch, MD., PhD	Hospital Clínico de Valencia
Principal Investigator:	Mª José Godes, MD., PhD.	Hospital General de Valencia
Principal Investigator:	Agustín Barnadas, MD., PhD.	Hospital San Creu i San Pau.
Principal Investigator:	Javier Cassinello, MD., PhD.	Hospital General de Guadalajara
Principal Investigator:	Miguel Ángel Seguí, MD., PhD.	Parc Taulí
Principal Investigator:	Álvaro Rodriguez Lescure, MD., PhD.	Hospital General de Elche
Principal Investigator:	José Ignacio Chacón, MD., PhD.	Hospital Virgen de la Salud
Principal Investigator:	Pilar López, MD., PhD.	hospital Ntra. Sra. de la Candelaria
Principal Investigator:	Adolfo Murias, MD., PhD	Hospital Insular de las Palmas
Principal Investigator:	Antonio Llombart, MD., PhD	Hospital Arnau de Vilanova de Lérida
Principal Investigator:	Ana de Juan, MD., PhD	Hospital Marqués de Valdecilla
Principal Investigator:	Ángel Guerrero, MD., PhD.	Instituto Valenciano de Oncología
Principal Investigator:	Amparo Oltra, MD., PhD	Hospital Virgen de los Lirios
Principal Investigator:	Juan de la Haba, MD., PhD.	Hospital Provincial Reina Sofía

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	GEICAM/2006-10
Study First Received:	October 11, 2007
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00543127
Health Authority:	Spain: Spanish Agency of Medicines

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Fulvestrant
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Estrogen Receptor Modulators
Estrogen Antagonists
Neoplasms
Neoplasms by Site
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Hormone Antagonists
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009