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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2007-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anastrozole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes