Featured Studies

Attention All Women who Participated in GOG-199, the National Ovarian Cancer Prevention and Early Detection Study for Women at Increased Genetic Risk of Ovarian Cancer

GOG and the National Cancer Institute have launched a new but closely-related follow-up study open only for women who participated in GOG-199. It extends the follow-up of GOG-199 participants for an additional 5 years, in an effort to improve the precision of cancer risk estimates and increase the usefulness of GOG-199-related biospecimens. The new study—designated GOG-8199—requires only the signing of a new consent form for the additional follow-up, and completion of a brief annual follow-up questionnaire by snail-mail, telephone or email. In-person visits to GOG study centers are NOT required. The new study does not include additional biospecimen collection, additional screening tests or the potential for surgery. It simply collects information on how participants are doing, and whether they have developed new cancers or undergone additional risk-reducing surgical procedures. This new information will be linked to the data that each GOG-199 participant has already contributed, substantially increasing the overall value and usefulness of the GOG-199 data base. Unfortunately, accrual to GOG-8199 has been distressingly slow, and GOG is at risk of losing its funding for this study if a substantial number of additional participants are not recruited by May 2012. We are asking GOG-199 study participants who might now be willing to consider joining this extension (GOG-8199) to contact the GOG site at which you were originally enrolled and discuss joining 8199 with your GOG research nurse. Please act at your earliest possible convenience, if we are to avoid the closure of this important addition to GOG-199. We offer a special shout-out to those of you who have already enrolled in GOG-8199. You are already in the system and do not need to respond to this request. Many thanks! Thank you all for having made GOG-199 such a success. Analyses of the major study end-points are now underway, and it is anticipated that important new findings will be published during the coming year.
-Mark H. Greene, M.D.
National Study Chair, GOG-199 and GOG-8199

PARP Inhibitor Open Research Studies

PARP inhibitors are experimental medications for treating cancer which scientists think may work particularly well for people with BRCA mutations. There are several PARP inhibitor studies open for different populations of patients. There is some evidence that different PARP inhibitors work differently so not all may have similar results in clinical trials. If you are considering enrolling in a clinical trial, it is recommended that you discuss the study with your health care team and the research team for each study. You can view a list of PARP inhibitor studies enrolling people with breast cancer and a list of PARP inhibitor studies enrolling people with ovarian cancer. We will be adding links to the different studies based on cancer type, (and when applicable, cancer subtype), stage of cancer, and type of PARP inhibitor. Please check our PARP inhibitor clinical trials page for updates.

Ovarian Cancer Novel Markers Trial

The Novel Markers Trial is a research study designed to help scientists develop and assess a blood test that can be used as a screening tool for detecting ovarian cancer at an earlier stage. The study's purpose is to understand how certain substances in the blood, called biomarkers, vary between women and over time. Women will be randomly (by chance) assigned to one of two groups when they enroll in the study. Women in group 1 will be screened with the biomarker CA 125 in combination with another biomarker, HE4. CA125 is currently used to detect recurrence of disease in patients already diagnosed with ovarian cancer and HE4 is a new, experimental marker. Women in group 2 will be screened with CA 125 alone; HE4 will be used only as a secondary screen if CA 125 results are abnormal. During the study, participants will be asked to have blood tests 1-2 times per year for up to 4 years and complete questionnaires.

To enroll in the study or for more information, call the Novel Markers Trial research office at 1-800-328-1124 or email the study manager at kwatabay@fhcrc.org or visit the study website.

RxPONDER Trial

The RxPONDER (Rx for Positive Node, Endocrine Responsive Breast Cancer) trial will study whether chemotherapy benefits patients with estrogen receptor positive and node positive breast cancer who have low to intermediate Oncotype DX recurrence scores. The Oncotype DX test measures the expression, or activity, level of 21 specific genes within
a tumor sample and based on that pattern assigns a recurrence score of anywhere from 0 to 100. Earlier trials have shown that the higher the recurrence score, the more likely the
patient’s cancer will recur and the more they will likely benefit from chemotherapy. The study is being run through the Southwest Oncology Group (SWOG) a cancer clinical trial cooperative group supported by the National Cancer Institute. For mre information visit the SWOG study site.

Prevention Studies for Women at High Risk for Breast Cancer

If you are at high risk you may qualify for one of several studies listed below using medication to prevent breast cancer. The Breast Cancer Prevention Center at KU Medical Center has several open studies for breast cancer prevention. For more information or to enroll, call (913) 588-3666 or visit the prevention study website.

Letrozole Phase II Trial for Women on Hormone Replacement Therapy (open to postmenopausal women)
Letrozole (also known as Femara) is an FDA-approved drug for breast cancer treatment. It belongs to a class of drugs called aromatase inhibitors which reduce the estrogen levels in the breast tissue.  In this six-month study, participants already on hormone replacement therapy are given 6 or 12 months of Letrozole to reduce breast estrogen, rate of breast cell growth, and the proportion of women who have breast cells which appear atypical without exacerbating menopausal symptoms In a preliminary six-month study of Letrozole, cell growth in the breast ducts was reduced by 2/3 without increasing menopausal symptoms.

Omega-3  Fatty Acid Trial (open to pre- or postmenopausal women)
Epicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are anti-inflammatory omega 3 fatty acids. Studies suggest that ingestion of higher amounts of EPA and DHA relative to omega 6 fatty acids may reduce the risk of breast cancer. This is a 6 month trial of high dose EPA and DHA per day in the form of 4 Lovaza capsules to determine the effect on blood and breast tissue markers of risk.  Most women entering this trial will not be on hormone replacement therapy.

Flaxseed Lignan for women 21-49 not taking oral contraceptives. (open to premenopausal women)
Lignans are weak estrogens found in nature in edible plants particularly in oily seeds such as flaxseed. One of the most common plant lignans, secoisolariciresinol diglycoside or SDG for short, in premenopausal women may act as a buffer to the estrogen produced by her body.  This is a study for women with atypia or borderline atypia in their tissue and evidence of a higher than normal growth rate as assessed by fine needle aspiration. The trial will determine whether 12 months of the flaxseed extract SDG vs a placebo reduces the rate of breast cell growth and the proportion of premenopausal women who have breast cells which appear atypical.

WISER Sister Study

A new federally funded study from the University of Pennsylvania School of Medicine is looking at whether women at high risk of breast cancer can use exercise to meaningfully reduce their risk of getting the disease. Building on evidence that reducing estrogen in the body reduces cancer risk, and that elite female athletes experience a drop in estrogen levels that often cause them to stop ovulating and menstruating, the WISER Sister trial will investigate two different levels of regular treadmill exercise as a possible intervention for breast cancer risk reduction.

Key eligibility criteria include:

• Age 18-40
• Family history, but have NOT had breast or ovarian cancer yourself
• Willing to be off any hormonal medications during the study (including tamoxifen and hormonal contraceptives)
• Can live anywhere in the U.S. to participate. Travel expenses will be reimbursed if you live more than 75 miles away.

Email the researchers for more information or click here to learn more.

 

Page updated 08/31/11

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