 |
|
Fulvestrant (Faslodex) + Anastrozol (Arimidex) vs Anastrozol
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
|
Phase
|
|
|
|
Type
|
|
|
|
Status
|
|
|
|
Age
|
|
|
|
Sponsor
|
|
|
|
Protocol IDs
|
|
|
|
Phase III
|
|
|
|
Treatment
|
|
|
|
Approved-not yet active
|
|
|
|
18 to 80
|
|
|
|
Other
|
|
|
|
GEICAM/2006-10
NCT00543127
|
|
|
Trial Description
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. Eligibility 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.)
Trial Contact Information
Trial Lead Organizations/Sponsors Grupo Espanol de Investigacion del Cancer de Mama AstraZeneca Pharmaceuticals LP
| Miguel Martín Jiménez, MD., PhD. | | Study Chair |
| Manuel Ramos Vázquez, MD., PhD. | | Study Chair |
| Manuel Ruiz Borrego, MD., PhD. | | Study Chair |
| Alberto Moreno, MD. PhD. | | Principal Investigator |
| José Manuel Baena Cañada, MD., PhD. | | Principal Investigator |
| Silvia Antolín, MD., PhD | | Principal Investigator |
| José Luis Alonso Romero, MD., PhD | | Principal Investigator |
| Angels Arcusa Lanza, MD. PhD | | Principal Investigator |
| Isabel Moreno, MD., PhD. | | Principal Investigator |
| Isabel Álvarez, MD. PhD. | | Principal Investigator |
| Juan Carlos Toral, MD., PhD | | Principal Investigator |
| Isabel Calvo, MD., PhD | | Principal Investigator |
| Pedro Sanchez Rovira, MD. PhD. | | Principal Investigator |
| Javier Salvador Bofill, MD., PhD. | | Principal Investigator |
| Francisco Carabantes, MD., PhD | | Principal Investigator |
| Emilio Alba, MD., PhD | | Principal Investigator |
| Juan Bayo, MD., PhD. | | Principal Investigator |
| Jesús Florián, MD., PhD. | | Principal Investigator |
| Antonio Antón, MD., PhD. | | Principal Investigator |
| José Ignacio Mayordomo, MD., PhD. | | Principal Investigator |
| Ignacio Pelaez, MD., PhD. | | Principal Investigator |
| Montserrat Muñoz, MD., PhD | | Principal Investigator |
| Sonia González, MD., PhD. | | Principal Investigator |
| Ana Lluch, MD., PhD | | Principal Investigator |
| Mª José Godes, MD., PhD. | | Principal Investigator |
| Agustín Barnadas, MD., PhD. | | Principal Investigator |
| Javier Cassinello, MD., PhD. | | Principal Investigator |
| Miguel Ángel Seguí, MD., PhD. | | Principal Investigator |
| Álvaro Rodriguez Lescure, MD., PhD. | | Principal Investigator |
| José Ignacio Chacón, MD., PhD. | | Principal Investigator |
| Pilar López, MD., PhD. | | Principal Investigator |
| Adolfo Murias, MD., PhD | | Principal Investigator |
| Antonio Llombart, MD., PhD | | Principal Investigator |
| Ana de Juan, MD., PhD | | Principal Investigator |
| Ángel Guerrero, MD., PhD. | | Principal Investigator |
| Amparo Oltra, MD., PhD | | Principal Investigator |
| Juan de la Haba, MD., PhD. | | Principal Investigator |
| Manuel Ramos Vázquez, MD., PhD. | | Ph: 0034981 287499 | | |
Email:
omedica@cog.es |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00543127
Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
Back to Top |
 |
