Protocol for Women at Increased Risk of Developing Breast Cancer

Carol Fabian, MD

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: letrozole

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00291135

8884

Details and patient eligibility

About

A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

Full description

A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.

Enrollment: 42 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
• on hormone replacement therapy
• postmenopausal
• increased risk of developing breast cancer based on personal or family history
• never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
• women who have a high risk of breast cancer
• older than 18 years

Exclusion criteria

• anticoagulants
• marked breast tenderness
• pregnant or within twelve months of breast feeding/childbirth

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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42 participants in 1 patient group

1

Experimental group

Description:

Oral Letrozole 2.5 mg daily for six months

Treatment:

Drug: letrozole