January 02, 2025
BANGOR DAILY NEWS (BANGOR, MAINE

Mainers recruited to test new breast cancer drug> Women reap health bebnefits of tamoxifen trials

BANGOR — As trials go, these are lengthy, lacking in drama, and often inconclusive. But whatever their outcome, the myriad clinical drug trials conducted in America are the backbone for developing treatments for everything from cancer to indigestion.

A trial typically goes like this: One group of patients who took a “dummy” drug is compared to another group who took the real thing. If the second group shows a statistically significant therapeutic and preventive outcome — without major side effects — then the drug will be seriously considered for approval by the U.S. Food and Drug Administration.

Sometimes a drug’s side effects outweigh its benefits, or its efficacy is slight over a multiyear trial. Many drug trials end in a sort of pharmaceutical hung jury.

Not so with the five-year clinical trial involving 13,000 American women taking tamoxifen who showed a dramatically lower incidence of breast cancer. The verdict in September was unequivocal: Women at high risk for breast cancer developed the disease at almost half the rate as did those taking a placebo. For some of the 45 Maine women who have completed their participation in the study, the results translated into tangible health benefits.

Lorraine Chase, 55, of Brewer was a recipient of that good fortune. When she heard about the study in 1992, she was interested. Her mother, grandmother and sister all had breast cancer, and she knew she was at high risk herself. Not only that, she thought about her three daughters who someday would be facing the genetic predisposition to breast cancer.

“I really felt that I should do it for future generations,” Chase said. “I’m not presenting myself as some kind of heroic thing. It was just something I felt I had to do.”

Now, on the eve of a much broader study of tamoxifen and raloxifene, a similar drug, more high-risk Maine women are being asked to sign on.

Eastern Maine Medical Center’s cancer ward, CancerCare of Maine, is looking to enroll at least 250 women for a five-year study that is likely to begin in early 1999. This second phase of tamoxifen testing will enroll post-menopausal women over age 35.

“We wanted this available for the women of our area,” said Dr. A. Merrill Garrett, an oncologist at EMMC who heads the Maine segment of the trial.

“The last study required that the participants understand that there was a 50-50 chance of their getting a placebo,” Garrett said. As such, women who enrolled in the first trial were not largely motivated by the hope of personal gain, but by a desire to participate in the slow, methodical quest to cure and prevent breast cancer.

“The second study will attract women who want to help themselves,” she said. “There’s no chance of them getting inactive drugs.”

Ambie Hayes-Crosby, the program’s coordinator, said that most women who participated in the first trial told her stories about mothers and sisters who had breast cancer, or talked about the risk of cancer their young daughters might one day face.

Breast cancer accounted for 15 percent, or 200 cases, of all cancer cases diagnosed by CancerCare of Maine last year, according to Suanne Thurman, executive director. The American Cancer Society estimates that there were 8,200 cases of cancer diagnosed in Maine in 1997, with 990 of those breast cancer.

During the second trial, 11,000 women will take tamoxifen and 11,000 will take raloxifene, which is expected to have fewer side effects. Tamoxifen’s most serious side effect is a slight increase in uterine cancer.

Previous research had shown that tamoxifen reduced recurrence of breast cancer in women who had been successfully treated for the disease. Tamoxifen blocks hormones that breast cancer often uses as a means to spread through the body.

During the first trial, all participants had to come to CancerCare of Maine for all checkups related to the trial. “Some women traveled three hours to get here,” said Hayes-Crosby.

The second trial will be administered locally, using primary care physicians. Women who received a placebo during the first trial might be eligible for the new one.

A clinical trial follows strict scientific guidelines called a protocol. A protocol determines how many people will be in the study, who’s eligible, what drugs will be taken and how often testing will be done. The protocol has not yet been completed for the second tamoxifen trial, Garrett said.

Once it is, EMMC’s human rights board will review it, considering patients’ rights and the study’s medical and ethical merit.

Women interested in the study will fill out a questionnaire on personal and family history, which is used to determine hormonal and genetic factors that equate to higher risk for breast cancer. Garrett said some women are surprised to learn that they are not at high risk for the disease even though one of their relatives had it.

If the profile indicates high risk, candidates will discuss the findings with hospital personnel. “Basically it’s a consent process,” Garrett said.

Participants may quit the study at any time, but Garrett said that rarely happens. Participants are not paid, but they receive the medication for free. Most checkups during the five-year testing period are the routine exams covered under most health care plans.

If minor side effects or unexplainable conditions crop up during the trial period, they are reported to the national databank for the trial. If those side effects are reported in great numbers, they could lead to a premature discontinuation of the trial. If a particular side effect bothers few participants, the condition will be mentioned in the prescription drug package in the event of FDA approval.

If participants have more severe side effects, they might have to drop out of the trial.

“It’s hard to take two pills a day and not know what you’re taking, not know what it might be doing to your body,” said Chase, who is an office manager for a group of internal medicine specialists in Bangor. She had no negative side effects from the tamoxifen.

“I felt like a pioneer woman when I found out the results of the test,” she said. “I’d do it again — in a minute.”


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