Fulvestrant (Faslodex) + Anastrozol (Arimidex) vs Anastrozol
Information source: Spanish Breast Cancer Research Group
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: fulvestrant + anastrozol (Drug); Anastrozol (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: Spanish Breast Cancer Research Group Official(s) and/or principal investigator(s): Miguel Martín Jiménez, MD., PhD., Study Chair, Affiliation: Hospital Clínico San Carlos Manuel Ramos Vázquez, MD., PhD., Study Chair, Affiliation: Centro Oncológico de Galicia Manuel Ruiz Borrego, MD., PhD., Study Chair, Affiliation: Hospital Virgen del Rocío Alberto Moreno, MD. PhD., Principal Investigator, Affiliation: Hospital de Jerez José Manuel Baena Cañada, MD., PhD., Principal Investigator, Affiliation: Hospital Puerta del Mar Silvia Antolín, MD., PhD, Principal Investigator, Affiliation: Complejo Hospitalario Juan Canalejo José Luis Alonso Romero, MD., PhD, Principal Investigator, Affiliation: Hospital Virgen de la Arrixaca Angels Arcusa Lanza, MD. PhD, Principal Investigator, Affiliation: Consorci Sanitari de Terrasa Isabel Moreno, MD., PhD., Principal Investigator, Affiliation: Hospital Municipal de Badalona Isabel Álvarez, MD. PhD., Principal Investigator, Affiliation: Hospital de Donostia Juan Carlos Toral, MD., PhD, Principal Investigator, Affiliation: Hospital de Torrevieja Isabel Calvo, MD., PhD, Principal Investigator, Affiliation: Hospital Madrid Norte Sanchinarro Pedro Sanchez Rovira, MD. PhD., Principal Investigator, Affiliation: Complejo Hospitalario de Jaén Javier Salvador Bofill, MD., PhD., Principal Investigator, Affiliation: Hospital de Valme Francisco Carabantes, MD., PhD, Principal Investigator, Affiliation: Hospital Carlos Haya Emilio Alba, MD., PhD, Principal Investigator, Affiliation: Hospital Virgen de la Victoria Juan Bayo, MD., PhD., Principal Investigator, Affiliation: Complejo Hospitalario de Especialidades Juan Ramón Jimenez Jesús Florián, MD., PhD., Principal Investigator, Affiliation: Hospital Comarcal de Barbastro Antonio Antón, MD., PhD., Principal Investigator, Affiliation: Hospital Miguel Servet José Ignacio Mayordomo, MD., PhD., Principal Investigator, Affiliation: Hospital Clinico Lozano Blesa Ignacio Pelaez, MD., PhD., Principal Investigator, Affiliation: Hospital de Cabueñes Montserrat Muñoz, MD., PhD, Principal Investigator, Affiliation: Hospital Clinic i Provincial de Barcelona Sonia González, MD., PhD., Principal Investigator, Affiliation: Hospital Mutua de Terrassa Ana Lluch, MD., PhD, Principal Investigator, Affiliation: Hospital Clínico de Valencia Mª José Godes, MD., PhD., Principal Investigator, Affiliation: Hospital General de Valencia Agustín Barnadas, MD., PhD., Principal Investigator, Affiliation: Hospital San Creu i San Pau. Javier Cassinello, MD., PhD., Principal Investigator, Affiliation: Hospital General de Guadalajara Miguel Ángel Seguí, MD., PhD., Principal Investigator, Affiliation: Parc Taulí Álvaro Rodriguez Lescure, MD., PhD., Principal Investigator, Affiliation: Hospital General de Elche José Ignacio Chacón, MD., PhD., Principal Investigator, Affiliation: Hospital Virgen de la Salud Pilar López, MD., PhD., Principal Investigator, Affiliation: hospital Ntra. Sra. de la Candelaria Adolfo Murias, MD., PhD, Principal Investigator, Affiliation: Hospital Insular de las Palmas Antonio Llombart, MD., PhD, Principal Investigator, Affiliation: Hospital Arnau de Vilanova de Lérida Ana de Juan, MD., PhD, Principal Investigator, Affiliation: Hospital Marqués de Valdecilla Ángel Guerrero, MD., PhD., Principal Investigator, Affiliation: Instituto Valenciano de Oncología Amparo Oltra, MD., PhD, Principal Investigator, Affiliation: Hospital Virgen de los Lirios Juan de la Haba, MD., PhD., Principal Investigator, Affiliation: Hospital Provincial Reina Sofía
Summary
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.
Clinical Details
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.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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.
Secondary outcome: 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
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Female.
Criteria:
Inclusion Criteria:
1. Written signed informed consent.
2. Breast cancer histologically confirmed.
3. Stages I, II, IIIA of invasive breast cancer. Patients must comply with one of the
following characteristics: N+, T > 2 cm.
4. Mastectomy or lumpectomy with free margins + radiotherapy, axilar node dissection or
centinel node dissection.
5. Positive hormonal receptors (ER+ and/or PgR+) determined at a central laboratory.
6. Negative HER2 (defined as IHQ 0 or 1+ or negative FISH when IHQ 2+ or 3+).
7. 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).
8. ECOG = 0, 1 or 2.
9. Age > 18 years.
Exclusion Criteria:
1. Metastatic disease or invasive bilateral breast cancer.
2. Negative ER and PgR breast cancer.
3. Treatment with a not approved or experimental drug within 4 weeks before
randomization.
4. 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).
5. Pregnant or lactating women. 6. Concurrent hormone replacement therapy and other
hormonal agents (raloxifen, tamoxifen,etc.)
Locations and Contacts
Spanish Breast Cancer Research Group (GEICAM), San Sebastián de los Reyes, Madrid 28703, Spain
Additional Information
Starting date: November 2007
Last updated: October 25, 2011
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