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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235937
First Posted: October 12, 2005
Last Update Posted: January 21, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00235937     History of Changes
Other Study ID Numbers: D5390L00061 Roche Study
THR 0104233 C
First Submitted: October 10, 2005
First Posted: October 12, 2005
Last Update Posted: January 21, 2011
Last Verified: January 2011

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
Anastrozole
Goserelin
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs