Know Cancer

or
forgot password

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.


Phase 3
18 Years
80 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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.


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.)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

5 years

Safety Issue:

Yes

Principal Investigator

Miguel Martín Jiménez, MD., PhD.

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Clínico San Carlos

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM/2006-10

NCT ID:

NCT00543127

Start Date:

November 2007

Completion Date:

November 2015

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location