Fulvestrant (Faslodex) + Anastrozol (Arimidex) vs Anastrozol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543127
Recruitment Status : Terminated (Unjustified decision of company that funded the trial.)
First Posted : October 12, 2007
Last Update Posted : October 26, 2011
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: fulvestrant + anastrozol Drug: Anastrozol Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 872 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : November 2007
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543127

Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28703
Sponsors and Collaborators
Spanish Breast Cancer Research Group
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 Universitario 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. Complejo Hospitalario de Especialidades Juan Ramón Jimenez
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

Additional Information:
Responsible Party: Spanish Breast Cancer Research Group Identifier: NCT00543127     History of Changes
Other Study ID Numbers: GEICAM/2006-10
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: October 26, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action