Ensayo fase III aleatorizado, multicéntrico, abierto, de grupos paralelos para comparar la eficacia y tolerabilidad de Fulvestrant (Faslodex®) durante tres años en combinación con Anastrozol (Arimidex®) durante 5 años versus Anastrozol durante 5 años como tratamiento hormonal adyuvante en mujeres posmenopáusicas con cáncer de mama temprano y receptores hormonales positivos. A randomized, multicentral, phase III study of parallel groups to compare the efficiency and tolerance of Fulvestrant (Faslodex) administered for three years in combination with Anastrozol (Arimidex) for 5 years versus Anastrozol for 5 years as adjuvant hormonotherapy in postmenopausal women with early breast cancer and positive hormonal receptors.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003417-14-ES

Enrollment

3180

Registered

2007-08-21

Start date

2007-09-14

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postmenopausal women with operable breast cancer and positive hormonal receptors who are eligible to be treated with adjuvant hormonotherapy. MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer

Interventions

Trade Name: FASLODEX® Pharmaceutical Form: Solution for injection Trade Name: ARIMIDEX® Pharmaceutical Form: Coated tablet

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.)

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare free disease survival of patients treated with Fulvestrant for 3 years and anastrozol for 5 years vesus free disease survival of patients treated with anastrozol for 5 years. ;Secondary Objective: 1. To compare breast cancer specific survival between both arms of treatment. 2. To compare overall survival between both arms of treatment. 3. To compare safety profile and tolerance between both arms of treatment. ;Primary end point(s): Free disease survival defined as period of time without evidence of local and / or distant recurrence, second primary tumour of the breast or death for any reason.	—

Measure

Time frame

Main Objective: To compare free disease survival of patients treated with Fulvestrant for 3 years and anastrozol for 5 years vesus free disease survival of patients treated with anastrozol for 5 years. ;Secondary Objective: 1. To compare breast cancer specific survival between both arms of treatment. 2. To compare overall survival between both arms of treatment. 3. To compare safety profile and tolerance between both arms of treatment. ;Primary end point(s): Free disease survival defined as period of time without evidence of local and / or distant recurrence, second primary tumour of the breast or death for any reason.

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Countries

Spain

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026