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Other Studies

Search through ClinicalTrials.gov This site, produced by the U.S. National Library of Medicine (NLM), provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.

Prevention and Surveillance Studies

  • Letrozole Phase II Breast Cancer Prevention 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 Breast Cancer Prevention 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 Breast Cancer Prevention Trial 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.

  • 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.

Treatment Studies for People with Cancer

PARP Inhibitor Studies

Breast Cancer Studies

This study is open in multiple sites across the US. The study is investigating the PARP inhibitor niraparib for women with previously treated HER2 negative, BRCA positive breast cancer.

Ovarian Cancer Studies


Pancreatic, Prostate or Other Hereditary Cancer Studies

Other PARP Inhibitor Research

Below are links to clinicaltrials.gov where you may find more information on other PARP Inhibitor studies.


Other Targeted Therapy Research for Hereditary Cancers


Inherited Cancer Registry(ICARE)

he Inherited Cancer Registry (ICARE) Initiative is a research registrythrough Moffitt Cancer Center for individuals interested in participating in studies about hereditary cancer. With a goal of improving the lives of at risk patients and their families, our mission is to end the cycle of inherited cancer through research, education and outreach. To contact the ICARE team, fill out the form through this link.

To enroll directly in ICARE research efforts, visit this link.


INFORM Study

This is a study for women with BRCA mutations who are newly-diagnosed with breast cancer evaluating whether the chemotherapy drug cisplatin is better than currently used standard chemotherapy drugs (Cyclophosphamide/Doxorubicin) for treating patients. The study is open at several institutions. You can view the study flier and the study page on clinicaltrials.gov for more information.


InVite Study

Update: Genentech and 23andMe, a genetic testing company, have recently partnered to launch a new breast cancer research initiative to determine if a person’s genes could play a role in how they respond to bevacizumab (also known as Avastin®). The InVite study is enrolling individuals who have received bevacizumab (also known as Avastin®) for metastatic cancer prior to 2013. The study has been expanded to enroll people who received Avastin for the following cancers:

  • metastatic breast cancer
  • metastatic colorectal cancer
  • metastatic non-squamous, non-small cell lung cancer
  • relapsed glioblastoma
  • metastatic renal cell carcinoma

Participation is free, but you must have access to a computer and the Internet. Participants in the study will submit DNA samples via an at-home saliva collection kit and potentially a blood sample through a qualified laboratory.  You will create an online account to take surveys about your experience with Avastin and to receive updates on research progress. You also have the option to join the 23andMe service (for free) to learn more about genetics and your health and ancestry, genetic counseling with a qualified expert is strongly recommended prior to joining 23andMe's service.


Registry for women who have undergone salpingectomy (tubes only) surgery

Have you had your fallopian tubes surgically removed and kept one or both of your ovaries? Did you have this surgery to reduce your ovarian cancer risk? Researchers at the University of Washington in collaboration with Facing Our Risk of Cancer Empowered (FORCE) are studying the long-term outcomes of prophylactic salpingectomy (removal of the fallopian tubes). To learn more about this research study, call 206-685-7927 or email vhy@uw.edu orkagnew@uw.edu. They cannot ensure the confidentiality of any information sent by e-mail.



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.


Can Undetected Familial Mutations in BRCA1 and BRCA2 Genes Explain Some Cancer in BRCA Non-Carriers? A Pilot Project

The study is recruiting cancer patients from families with a known BRCA 1 or 2 gene mutation who tested negatively for the mutation in the family.

This study is open to people who:

  • who had breast or ovarian cancer
  • Are first-degree relatives of the known BRCA mutation carriers
  • Are a patient who had negative blood test for this known familial BRCA mutation
  • Are a man or woman with other types of cancer meeting criteria 2 and 3 (may be eligible on a case-by-case basis)
  • Are second- and third-degree relatives of the known BRCA mutation carriers meeting criteria 1 and 3 (may be eligible on a case-by-case basis)

For more information, visit the study website. You do not have to travel for this study but researchers will request your tissue to be sent from the treating hospital to the research center.



GOG-0225: Effects of Diet and Exercise in Ovarian Cancer Survivors

Emerging research suggests that exercise and weight control can play a role in breast cancer survival. But similar studies for ovarian cancer survival have not yet been done. A new study from the Gynecologic Oncology Group — a cooperative organization of the National Cancer Institute – will investigate whether women treated for ovarian cancer benefit from a program to control diet, nutrition, and weight. Researchers hope to recruit over 1,000 women at study sites around the United States. The study is open to women who:

  • have ovarian, primary peritoneal, or fallopian tube cancer in stages Stage II, III, or IV;
  • have completed all primary chemotherapy and consolidation therapy (if administered) between six weeks and six months prior to enrollment;
  • have achieved a documented complete response (no clinical evidence of persistent or recurrent disease) to treatment based on a normal CA-125 test and CT scan.

Visit the clinicaltrials.gov website for more information and a list of study sites.


Treatment studies for "triple-negative" breast cancer

"Triple-negative" breast cancer refers to a type of breast cancer that is particularly common in women with BRCA1 mutations. These cancers are estrogen- and progesterone-receptor negative, and also negative for overexpression of Her2neu. Approximately 85% of BRCA1 breast cancers are "triple-negative." Researchers are studying whether certain treatments may work particularly well for "triple-negative" cancers. Below are links to studies for triple-negative breast cancers.

Other treatment studies

 

Updated 03/05/14


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