A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer

January 29, 2013 updated by: AstraZeneca
The overall objective of the clinical study is to assess the tolerability and clinical efficacy of anastrozole in post-menopausal women with hormone sensitive advanced breast cancer in India.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Patients must be adult (age ≥ 18 years age) post-menopausal* women
  2. Patients must be diagnosed with advanced breast cancer (histologically or cytological confirmation required) i.e. TNM stage III or IV disease (locally advanced or metastatic breast cancer) or locoregional recurrent disease, not suitable for treatment by local surgery or radiation therapy
  3. Measurable or evaluable disease
  4. Patients with ER/PR positive tumour or ER/PR unknown status
  5. Patients must be suitable for endocrine treatment with anastrozole
  6. Prior adjuvant chemotherapy or endocrine therapy for early breast cancer is allowed, provided such treatment was completed at least twelve months prior to study enrollment
  7. Performance status 0-2 (As per WHO Classification)
  8. Concurrent use of bisphosphonates is permitted.
  9. Patients must give their written informed consent for participation in the study

Exclusion Criteria:

  1. Patients with tumors known to be estrogen and progesterone receptor-negative.
  2. Estrogen hormone replacement therapy, concurrently or within 6 weeks before randomization
  3. Extensive visceral involvement (significant hepatic involvement, brain metastasis or pulmonary involvement > 50% of the lungs); serum liver enzymes SGOT and SGPT should be no greater than five times the upper limit of the reference range
  4. Patients received bone marrow transplantation before randomization
  5. Any concurrent medical illness (uncontrolled cardiac disease or diabetes mellitus) or laboratory abnormalities that would compromise safety or prevent interpretation of results
  6. An estimated survival of less than 3 months from the start of Study drug treatment based on clinical judgment.
  7. Any systemic investigational drug within the thirty days of enrollment into study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
1. Tolerability(safety) 2.Efficacy (a) Time to tumor progression TTP (b) Objective Response (OR) Rate (c) Symptom Evaluation

Secondary Outcome Measures

Outcome Measure
Efficacy (a) Time to treatment failure TTF (b)Duration of Response DOR (c) Duration of Clinical Benefit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Poonamalle P Bapsy, MD, Kidwai Memorial Institute of Oncology, Bangalore, INDIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

November 1, 2007

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

October 8, 2007

First Submitted That Met QC Criteria

October 15, 2007

First Posted (Estimate)

October 16, 2007

Study Record Updates

Last Update Posted (Estimate)

January 30, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5391L00001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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