NCI Press Office
After five years, recruitment for the Breast Cancer Prevention Trial
(BCPT) ended May 30, 1997, and results are expected in two to three years. The 13,000th
woman joined the study on May 20. Women who have qualified to participate, but who have not
completed pre-entry tests and examinations, have until Sept. 1, 1997 to enroll.
"Reaching this milestone is a tremendous accomplishment for the
oncology community," said Leslie Ford, M.D., associate director for early detection and
community oncology at the National Cancer Institute (NCI), and NCI coordinator for the study.
"Finding a way to prevent breast cancer is one of the most important research questions we have to
answer. Each and every woman who has chosen to participate has my gratitude for their trust and
conviction in seeing this study through."
Norman Wolmark, M.D., chairman of the Pittsburgh-based National
Surgical Adjuvant Breast and Bowel Project (NSABP), the NCI-sponsored research network
conducting the BCPT, also thanked and praised the participants. "Reaching this point in the
study represents an achievement of unprecedented dimension. Everyone recognizes that breast
cancer is a major health problem for women, and the 13,000 women who have entered this trial
are doing something positive and productive about it. The contribution they have
made in the fight against this disease is immeasurable."
Recruitment for the BCPT, the first large-scale, randomized study to
assess whether a five-year course of the breast cancer treatment drug tamoxifen (Nolvadex )
can prevent breast cancer in women at increased risk, began April 29, 1992. Researchers from
the NSABP originally estimated that they would need 16,000 participants. Last September, they
announced that the participants, on average, had a much greater underlying risk of breast
cancer than anticipated, so only 13,000 women would be needed.
To qualify for participation, a woman had to be at least 35 years of
age and have a risk of developing breast cancer in the next five years that was 1.7 percent (17 of
1,000 women at this level of risk would be expected to develop breast cancer within five
years). Women aged 60 years and older qualified based on age alone, but women 35 to 59 had to have risk
factors that increased their risk to this level. On average, the women who volunteered
had at least twice that risk.
Breast cancer risk was evaluated based on the following factors: the
number of first-degree relatives (mother, daughter, or sisters) who have been
diagnosed with breast cancer, whether or not a woman has had any children and her age at her first
delivery, the number of times a woman has had breast lumps biopsied (especially if she has a
condition known as atypical hyperplasia), her age at her first menstrual period, and if she has a type
of noninvasive breast cancer known as lobular carcinoma in situ.
The participants represent each of three age groups about equally:
Ages 35 to 49 (premenopausal), ages 50 to 59 (perimenopausal), and age 60 and older
(postmenopausal). About 4 percent of the women are from a racial or ethnic minority group
(African-American, Hispanic, Asian, or other).
The 13,000 women have been randomized (divided by chance) to take
either 20 milligrams of tamoxifen daily or a placebo for five years. All of the participants
will take their tamoxifen or placebo for the full five years, unless early beneficial or adverse results
are seen. An independent review committee regularly reviews interim results to ensure the safety of
the participants. Participants who complete five years of therapy will be followed for at
least two more years.
Rici Rutkoff, one of the co-chairs of the BCPT Participant Advisory
Board, a group of 16 women who participate in the trial, shares the enthusiasm. "I'm thrilled
that we've reached our accrual goal because now we can get down to the business of finding out if
tamoxifen will prevent breast cancer," she said. Sandi Kanicki, the other co-chair, feels
privileged to be part of the study, adding, "Since joining the trial I have become a real advocate for women's health, which will carry on long after the study is over. My five-year commitment to the
study has become a life-long commitment."
BCPT researchers are also conducting smaller studies involving
portions of the 13,000 participants to assess the action of tamoxifen on blood lipid levels (such
as cholesterol) and bone density. Although tamoxifen is an anti-estrogen, it works against estrogen
in some tissues and like estrogen in others. Its actions like estrogen help reduce blood
lipids, which may ultimately reduce the number of heart disease deaths that occur, and help retain bone
Tamoxifen is one of the most widely prescribed cancer drugs in the
world, with more than 20 years of research studying its actions, benefits, and risks. Zeneca
Pharmaceuticals, Wilmington, Del., manufactures tamoxifen and provides both the tamoxifen
and placebo pills for the study without charge.
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