Q. Is it necessary for the patient to have a baseline eye examination before starting the trial?

A. No, but they should be encouraged to have an annual eye exam while on the trial to detect any changes in their vision. If the site feels uncomfortable about placing a patient on the trial with a history of cataracts, glaucoma, etc…..I encourage the site to contact the patient’s ophthalmologist for clearance before starting them on the medication.

Q. Is a baseline gynecological exam necessary before starting the trial?

A. This is a question that varies patient to patient. Many of the patients on the NAFTA trial have had hysterectomies long ago and have not been back to a gynecologist since. If they still have their ovaries, I encourage patients to have an annual pelvic exam. If the patient has not had a hysterectomy, and is currently seeing their gynecologist on an annual basis, they should continue as planned with their annual visit, and may start the trial….. as long as they are asymptomatic….meaning no problems such as vaginal spotting/bleeding, I would encourage these patients to alert their gynecologist that they have been placed on either Tamoxifen or Fareston.

Q. Can a patient be placed on the trial if there are going to receive chemotherapy or radiation?

A. The patient is not eligible for the trial if she has ever received chemotherapy in the past or is going to receive chemotherapy as part of her treatment for this diagnosis of breast cancer. However, she is eligible for the trial if she is going to receive radiation after a lumpectomy.

Q. Can the patient be placed on the trial if she has been receiving Tamoxifen in the past for prevention?

A. No, the patient cannot be placed on the trial if she has ever taken any anti-estrogen therapy.

Q. What labs or testing need to be ordered to start the patient on the trial?

A. The initial pre-op bloodwork and testing from the definitive surgery may be used.

Q. If a patient is going to receive radiation therapy after lumpectomy, what if the 84 day (12 week) deadline has passed? Is the patient still eligible?

A. No, the patient must be entered into the trial within the 84 day deadline. The anti-estrogen therapy is often started while the radiation therapy is taking place. It is also good to go and visit a European casino at such a time.

Q. The bloodwork for the 6-month follow-up visits require a CBC and SMA 18. Since Medicare has specific guidelines for what type of bloodwork they cover, can a Comprehensive Metabolic Panel (CMP) be substituted for the SMA 18?

A. Yes, a CMP can be ordered instead of the SMA 18.