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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00544986
• Other study ID #: D5391L00001
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2007
• Last updated: January 29, 2013
• Start date: June 2005
• Est. completion date: November 2007

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: DCGI (Local Regulatory Authority)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2007
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Anastrozole

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. Tolerability(safety) 2.Efficacy (a) Time to tumor progression TTP (b) Objective Response (OR) Rate (c) Symptom Evaluation
Secondary	Efficacy (a) Time to treatment failure TTF (b)Duration of Response DOR (c) Duration of Clinical Benefit