A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00544986
First received: October 8, 2007
Last updated: January 20, 2011
Last verified: January 2011
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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:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Anastrozole
U.S. FDA Resources
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 |
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients must be adult (age ≥ 18 years age) post-menopausal* women
- 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
- Measurable or evaluable disease
- Patients with ER/PR positive tumour or ER/PR unknown status
- Patients must be suitable for endocrine treatment with anastrozole
- 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
- Performance status 0-2 (As per WHO Classification)
- Concurrent use of bisphosphonates is permitted.
- Patients must give their written informed consent for participation in the study
Exclusion Criteria:
- Patients with tumors known to be estrogen and progesterone receptor-negative.
- Estrogen hormone replacement therapy, concurrently or within 6 weeks before randomization
- 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
- Patients received bone marrow transplantation before randomization
- Any concurrent medical illness (uncontrolled cardiac disease or diabetes mellitus) or laboratory abnormalities that would compromise safety or prevent interpretation of results
- An estimated survival of less than 3 months from the start of Study drug treatment based on clinical judgment.
- Any systemic investigational drug within the thirty days of enrollment into study
Contacts and Locations
More Information
No publications provided
Keywords provided by AstraZeneca:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
No publications provided
ClinicalTrials.gov Identifier: | NCT00544986 History of Changes |
Other Study ID Numbers: | D5391L00001 |
Study First Received: | October 8, 2007 |
Last Updated: | January 20, 2011 |
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 October 17, 2012