Study on Pre-menopausal Patients With Advanced ER and PR + BC Treated With Arimidex Plus Zoladex
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
2 other identifiers
interventional
45
1 country
7
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Dec 2001
Typical duration for phase_2 breast-cancer
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
October 10, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 21, 2011
January 1, 2011
October 10, 2005
January 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the feasibility and efficacy of the combination of these 2 drugs in these patients
Secondary Outcomes (1)
To assess clinical benefit rate, time to progression, duartion of response and safety in patients treated with the combination of these 2 drugs
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (7)
Unknown Facility
Angers, France
Unknown Facility
Caen, France
Unknown Facility
Poitiers, France
Unknown Facility
Rennes, France
Unknown Facility
Rouen, France
Unknown Facility
Saint-Herblain, France
Unknown Facility
Toulouse, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca France Medical Director, MD
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 10, 2005
First Posted
October 12, 2005
Study Start
December 1, 2001
Study Completion
December 1, 2006
Last Updated
January 21, 2011
Record last verified: 2011-01