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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00544986
First received: October 8, 2007
Last updated: January 29, 2013
Last verified: January 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00544986

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

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00544986     History of Changes
Other Study ID Numbers: D5391L00001
Study First Received: October 8, 2007
Last Updated: January 29, 2013
Health Authority: India: DCGI (Local Regulatory Authority)

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
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Anastrozole
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 20, 2014