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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: October 8, 2007
Last updated: January 29, 2013
Last verified: January 2013
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.

Condition Intervention Phase
Breast Cancer Drug: Anastrozole Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

Secondary Outcome Measures:
  • Efficacy (a) Time to treatment failure TTF (b)Duration of Response DOR (c) Duration of Clinical Benefit

Study Start Date: June 2005
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00544986

Sponsors and Collaborators
Principal Investigator: Poonamalle P Bapsy, MD Kidwai Memorial Institute of Oncology, Bangalore, INDIA
  More Information

Responsible Party: AstraZeneca Identifier: NCT00544986     History of Changes
Other Study ID Numbers: D5391L00001
Study First Received: October 8, 2007
Last Updated: January 29, 2013

Keywords provided by AstraZeneca:
breast cancer
post menopausal women
Post menopausal women with hormone sensitive advanced breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists processed this record on July 19, 2017