Fulvestrant (Faslodex) + Anastrozol (Arimidex) vs Anastrozol
This study has been terminated.
(Unjustified decision of company that funded the trial.)
Sponsor:
Spanish Breast Cancer Research Group
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00543127
First received: October 11, 2007
Last updated: October 25, 2011
Last verified: October 2011
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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 + anastrozol Drug: Anastrozol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Fulvestrant
U.S. FDA Resources
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 872 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | November 2015 |
| Estimated Primary Completion Date: | November 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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 + anastrozol
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 anastrozol per day during 5 years.
|
|
Active Comparator: 2
Anastrozol 1 mg daily for 5 yeras.
|
Drug: Anastrozol
1 mg oral Anastrozol per day during 5 years.
|
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
Locations
| Spain | |
| Spanish Breast Cancer Research Group (GEICAM) | |
| San Sebastián de los Reyes, Madrid, Spain, 28703 | |
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
Additional Information:
No publications provided
| Responsible Party: | Spanish Breast Cancer Research Group |
| ClinicalTrials.gov Identifier: | NCT00543127 History of Changes |
| Other Study ID Numbers: | GEICAM/2006-10 |
| Study First Received: | October 11, 2007 |
| Last Updated: | October 25, 2011 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Estradiol Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Estrogen Antagonists Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Antineoplastic Agents, Hormonal Estrogens Hormones |
ClinicalTrials.gov processed this record on June 17, 2013