Faslodex Advanced Breast Cancer Local Chinese Study

A Double Blind, Double Dummy, Randomised, Multicentre Study to Compare the Efficacy and Safety of Fulvestrant 250mg With Arimidex 1mg as a Secondary-line Therapy in the Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00327769

Enrollment

234

Registered

2006-05-19

Start date

2005-11-30

Completion date

2007-09-30

Last updated

2011-01-25

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

Conditions

Advanced Breast Cancer

Keywords

Advanced breast cancer, fulvestrant, anastrozole

Brief summary

This study will evaluate the efficacy and safety of Faslodex as secondary-line treatment compared with Arimidex in oestrogen receptor positive postmenopausal advanced breast cancer.

Interventions

DRUGFulvestrant

250 mg intramuscular injection

DRUGAnastrozole

1 mg tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Postmenopausal advanced breast cancer with oestrogen receptor positive * Progression under first-line anti-oestrogen therapy.

Exclusion criteria

* Life-threatening metastasis; contraindication to anastrozole * \>2 regimens of hormonotherapy for advanced breast cancer

Design outcomes

Primary

Measure	Time frame
Time to Disease Progression (TTP)	—

Secondary

Measure	Time frame
Objective Response Rate (ORR)	—
Clinical Benefit Rate (CBR)	—
Time to Treatment Failure (TTF)	—
Safety & Tolerability.	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026