Protocol for Women at Increased Risk of Developing Breast Cancer

Carol Fabian, MD

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: celecoxib; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00291694

9118

Details and patient eligibility

About

To assess the effects of twelve months of celecoxib administration by evaluating breast tissue needle aspirations, to determine if cell growth can be slowed.

Full description

A blind randomized study of celecoxib in women at high risk of developing breast cancer. Subjects are to take twelve months of drug/placebo. At baseline and after twelve months subjects will have a random periareolar fine needle breast aspiration that will be assessed for epithelial cell growth and other markers of risk. Baseline and twelve month serum samples will also be assessed for hormones and growth factors which may be associated with breast cancer risk. Mammograms at baseline and twelve months will also be assessed for breast density changes.

Enrollment: 72 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

72 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Oral Celecoxib 400 mg twice daily for 12 months

Treatment:

Drug: celecoxib

2

Placebo Comparator group

Description:

Matched blinded placebo twice daily for 12 months

Treatment:

Other: placebo