The government's National Cancer Institute is seeking at least 300 volunteers with early breast cancer to help prove whether or not their disease can be cured without sacrificing the breast.
The result could help end breast removal as the standard treatment, if the trial turns out the way the doctors conducting it expect.
Three hundred is the minimum number of volunteers NCI doctors need for their computer-directed, randomized trial comparing total breast removal with removal of only the cancerous area -- an operation sometimes called "lumpectomy" -- followed by radiation.
Volunteers must let one treatment or the other be chosen at random by the computer. They will then get free treatment for life, including the offer of free breast reconstruction if their breast is removed.
The NCI's problem is that only 12 women have volunteered so far, though the trial began in September. At this rate it would take the doctors another six years just to get their study group.
The doctors don't blame women for being unwilling to volunteer, or their doctors for failing to tell them about the NCI offer.
"We simply think not enough women and not enough doctors know of the study," said NCI's Dr. Allen Lichter, radiation therapy chief at the big Clinical Center or research hospital on the National Institutes of Health grounds in Bethesda, the study site.
Lichter said he can understand the woman who feels she should stick with the usual medical recommedation -- breast removal -- or the doctor who feels lesser approaches won't work.
"Mastectomy or breast removal has been the standard treatment since 1893," he said. "But there are now decades of data on women treated with radiaton around the world. And many women are refusing mastectomies today.
"If we didn't believe strongly that a lesser operation plus radiation will prove as effective as total mastectomy, we wouldn't be doing this. It would not only be immoral and unethical, it would be illegal.
"And our ethical review board wouldn't let us go ahead if there were scientificaly solid evidence that total breast removal is better."
Women who have strong feelings for or against total breast removal shouldn't even consider volunteering, he added. "But many women are truly puzzled," he said, and "we find they are often relieved" to let a computer make the decision.
One of the study's ardent promoters -- "but only for women who are uncertain" -- is Rise Kushner of Kensington, former breast cancer patient, nationally known author of the book "Why Me?" and founder of a nonprofit and well-regarded Breast Cancer Advisory Center that councels the puzzled.
She says the NCI doctors are "desperate" for volunteers mainly because most surgeons "aren't about to give up their patients," since "its a matter of business for them" as well as "long-time belief."
She thinks scientific studies will show that millions of breasts can indeed be saved by less drastic treatments. "But the studies must be done so we can be sure," she emphasized.
Women any place in the country can apply for the program. All women treated will also have lymph glands removed from their armpit. If these show cancer spread, the women will also be given chemotherapy.
Those eligible must have proven or suspected cancer in stage I (a tumor of 2 centimeters or less without lymph glan involvement) or stage II (a tumor of 2 centimeters or less with lymph gland involvement, or a tumor 2 to 5 centimeters with or without lymph involvement).
Radiation treatment is not without risks. It can sometimes affect the breast's appearance. Any radiation can help cause, as well as cure, cancers.
Women or doctors who want more information, including the requirements for medical referral, may call the cancer institute at 496-5583.
Volunteers are also being sought, again almost desperately, for another, even larger NCI-sponsored breast cancer study. Several U.S. and Canadian centers are comparing three treatments: (1) breast removal; (2) removal of the cancer alone; (3)removal of the cancer followed by radiation. Here, too, underarm glands are always removed to see if more treatment is needed.
This study began in April 1976, but so far only 403 women are enrolled.
We're very disturbed," said NCI's Dr. Joseph Allegra. "There aren't even enough patients yet to start evaluation."
The only participating doctor in this area is E. George Elias, surgery professor at the University of Maryland Medical School in Baltimore. No Washington surgeon has agreed to participate.