Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00235937
First received: October 10, 2005
Last updated: January 20, 2011
Last verified: January 2011
  Purpose

The purpose of this study is to determine the efficacy and tolerance of the association of two drugs already marketed and used to treat your disease: Arimidex® 1 Mg per day per os and Zoladex® 3,6 Mg in injections under cutaneous once per month in subjects with breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Anastrozole and goserelin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open, Phase II Trial Assessing the Objective Response Rate After Combination of Arimidex® 1mg Per os/Day and Zoladex® 3.6 mg Sub Cut/Monthly as 1st Treatment for Premenopausal Receptor Positive Advanced or Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Determine the feasibility and efficacy of the combination of these 2 drugs in these patients

Secondary Outcome Measures:
  • To assess clinical benefit rate, time to progression, duartion of response and safety in patients treated with the combination of these 2 drugs

Estimated Enrollment: 45
Study Start Date: December 2001
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent, premenopausal women 18 years or older, histologically or cytologically confirmed locally advanced or metastatic breast cancer, suitable for endocrine treatment, no curative treatment available,, one or more measurable lesions, life expectancy more than 6 months, normal biological parameters.

Exclusion Criteria:

  • Presence of life-threatening metastases, previous endocrine therapy or chemotherapy for advanced or metastatic disease, any previous treatment with hormone (LH-RH) severe or uncontrolled systemic disease, pituitary adenoma, High risk of medullar compression.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00235937

Locations
France
Angers, France
Caen, France
Poitiers, France
Rennes, France
Rouen, France
Saint-Herblain, France
Toulouse, France
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca France Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00235937     History of Changes
Other Study ID Numbers: D5390L00061 Roche Study, THR 0104233 C
Study First Received: October 10, 2005
Last Updated: January 20, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by AstraZeneca:
Premenopausal
Advanced Breast Cancer
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Goserelin
Anastrozole
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014