ClinicalTrials.Veeva

Menu

A Trial Comparing the Efficacy and Tolerability of Faslodex With Nolvadex in Postmenopausal Women With Advanced Breast Cancer

AstraZeneca logo

AstraZeneca

Status and phase

Completed
Phase 3

Conditions

Breast Cancer
Metastasis

Treatments

Drug: Fulvestrant
Drug: Tamoxifen

Study type

Interventional

Funder types

Industry

Identifiers

NCT00241449
9238IL/0025

Details and patient eligibility

About

The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Nolvadex (tamoxifen) as first-line treatment for postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.

Enrollment

51 patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.

Postmenopausal women. Written informed consent to participate in the study.

Exclusion criteria

  • Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.

Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.

Treatment with an investigational or non-approved drug within one month of then start of the study.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

51 participants in 2 patient groups

1
Active Comparator group
Description:
Tamoxifen
Treatment:
Drug: Tamoxifen
2
Experimental group
Description:
Fulvestrant
Treatment:
Drug: Fulvestrant

Trial contacts and locations

139

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems