July 1, 2002
Dana-Farber/Harvard Cancer Center Seeks Candidates for Three Breast
Cancer Prevention Clinical Trials
The STAR Trial
The primary aim of the STAR Trial is to compare tamoxifen and raloxifene to determine which may best reduce the incidence of breast cancer with fewer side effects.
Eligibility Criteria:
Post menopausal women ages 35 and older who are at increased risk for breast cancer. Increased risk is defined as:
- A diagnosis of LCIS treated by local excision only, OR
- At least a 1.66 percent projected 5-year probability of developing invasive breast cancer as determined by the GAIL Model
Post menopausal is defined as:
- At least 12 months without menstrual bleeding, OR
- Prior documentation of TAH/BSO
Ineligibility Criteria:
- Prior or suspected invasive breast cancer or DCIS
- Prior LCIS treated with mastectomy, radiation, or systemic adjuvent therapy
- Bilateral or unilateral prophylactic mastectomy
- Current HRT use
- Prior non-breast malignancy (except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix), of any type within the past five years.
- Previous tamoxifen or raloxifene use unless it has been for less than three months.
If a woman is interested in STAR:
A telephone screening is performed and if she seems like a good candidate and is interested, an information packet is mailed to her. If she is found to be a high enough risk (1.66 on the Gail Model), she is eligible. She is called with this information and if she is interested, we set up an entry visit.
Enrollment:
Women who come in for an entry visit are interviewed about their past medical history, family cancer history and medication use. She must provide documentation of a mammogram within the past year, a pelvic exam also within the past year (if she has not had a TAH/BSO), and routine bloodwork. She also has a breast exam and signs the consent form.
Follow-up:
From here, if all is well, a participant is randomized to take tamoxifen or raloxifene. The medication is mailed to her. She comes in every six months for five years for an interview and a breast exam. After she takes the medication for five years, she is asked to come in for another two years of follow-up. She is required to continue having her mammogram and pelvic exam every year.
For additional information:
Women interested in learning more about this study should call Kim Jesus at (617) 632-2261.
