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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

Page last updated: August 20, 2015

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