Skip to main content
OpenTrials
Completed

NCT Number: NCT00328120

Faslodex 500mg Multiple Dose Tolerability Study in BC Patients

The primary objective of this study is to assess the tolerability of 500mg fulvestrant in postmenopausal women with hormone receptor positive, advanced or recurrent breast cancer

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Advanced Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Chiba, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Provision of written informed consent
  • Postmenopausal woman who fulfils any one of the following criteria:
  • Histological or cytological confirmation of breast cancer
  • Estrogen receptor positive (ER+) or progesterone receptor positive (PgR+).

Exclusion criteria

  • Having received any one of the following therapy for advanced or recurrent breast cancer
  • 2 or more regimens of hormonal therapy or immunotherapy or 2 or more regimens of chemotherapy, etc

Treatment and study plan

Fulvestrant

Drug

500 mg intramuscular injection

Other names: Faslodex, ZD9238

Primary outcomes

  1. The primary objective of this study is to assess the tolerability of 500mg fulvestrant

    Time frame: assessed when all patients have been in the study for 6 months

Secondary outcomes

  1. Pharmacokinetics

    Time frame: each visit

  2. Time to progression

    Time frame: assessed when all patients have been in the study for 6 months

  3. ORR

    Time frame: assessed when all patients have been in the study for 6 months

  4. Clinical benefit rate

    Time frame: assessed when all patients have been in the study for 6 months

  5. Time to response

    Time frame: assessed when all patients have been in the study for 6 months

  6. duration of response and changes in serum tumour markers

    Time frame: assessed when all patients have been in the study for 6 months

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open, Multicentre Phase I Clinical Study to Assess the Tolerability of Fulvestrant 500 mg in Postmenopausal Women With Hormone Receptor Positive Advanced or Recurrent Breast Cancer

Important dates

Study start
2004
Primary completion
2006
Study completion
2010
First posted
May 19, 2006
Registry last updated
Nov 17, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.