Research is the best way for the medical community to discover better methods to detect, prevent, or treat diseases such as cancer, or to improve quality of life. These discoveries are made through careful study of different medical options to determine benefits, limitations, and risks compared with current standard care. Participating in research allows people to contribute to medical knowledge and offers the opportunity to receive cutting-edge care. Participation in research is not without risk; and, in order to receive funding, researchers must follow stringent guidelines to assure all participants are aware of the risks and their rights prior to participating in research. The guidelines require “informed consent,” which explains the following to potential participants:

• the purpose of the research
• potential risks of the research
• criteria for participating in the research
• alternatives to participating in research
• contact information for reporting an adverse effect during the research
• the voluntary nature of the study and that participants can leave a research study at any time they choose

Clinical Trials
Researchers conduct clinical trials to test a new drug for treatment, relief of symptoms, or for prevention of disease. The process involves a systematic series of steps to assure the drug is safe and effective. These steps usually involve three “phases” of testing:

• Phase I trials usually involve a small number of patients and are designed to evaluate safety and optimal dosing of a new drug.
• Phase II trials further test a new drug’s safety and efficacy.
• Phase III trials involve a larger number of participants and compare new drugs to current standard treatments. Participants are usually randomly assigned to the group receiving standard treatment or the group receiving the new treatment. Phase III cancer treatment trials do not include a placebo arm (unless there is no standard treatment for that particular cancer). Placebo arms may be included in chemoprevention trials studying drugs that might lower cancer risk in people who do not already have the disease.

Links to active research 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

• Breast cancer surveillance trials
• Breast cancer prevention trials
• Breast cancer treatment trials
• Ovarian cancer surveillance trials
• Ovarian cancer prevention trials
• Ovarian cancer treatment trials

PARP Inhibitor Studies or Hereditary Cancer-Specific Treatment Studies

PARP Inhibitors are medications that may specifically target BRCA-associated cancers. Phase I and Phase II PARP Inhibitor studies are now enrolling patients at sites throughout the US and Europe. Below are links to information on PARP Inhibitor studies.

• PARP Inhibitor breast cancer studies on clinicaltrials.gov
• PARP Inhibitor ovarian cancer studies on clinicaltrials.gov
• PARP Inhibitor pancreatic cancer studies on clinicaltrials.gov
• PARP Inhibitor melanoma studies on clinicaltrials.gov

You can also call the following contacts at the institutions below regarding PARP Inhibitor clinical trials for breast cancer:

City of Hope Cancer Center (Los Angeles, CA)
o Sharon Sand at: ssand@coh.org
or call 1-877-482-HOPE (4673) extension 64316
* Dana-Farber Cancer Institute (Boston, MA)
o Kathryn Gantman at: kgantman@patners.org
or call 617-632-3574
* Memorial Sloan Kettering (New York, NY)
o Contact Dr. Mark Robson at: robsonm@mskcc.org
* University of Pennsylvania, Abramson Cancer Center (Philadelphia, PA)
o Jessica Genewski at: (215) 662-6388

Other detection or prevention studies
The following sections of the FORCE website list research studies which may not be not listed on ClinicalTrials.gov:

• Breast cancer chemoprevention studies
• Ovarian cancer chemoprevention studies
• Breast cancer surveillance studies
• Ovarian cancer surveillance studies

The following programs which are specific to hereditary breast and ovarian cancer list studies through their facilities:

• Creighton University Available Breast and Ovarian Studies
• Family Cancer Genetic Network Breast and/or Ovarian Cancer Research

Overview of registries
A cancer registry is a list designed to collect information about the occurrence of cancer such as:

• the types of cancers that occur
• the extent of cancer at the time of diagnosis (disease stage), and
• the kinds of treatment that patients receive
• patient outcomes of disease

The information generally is stored without any personal identification, protecting the confidentiality of participants. This data is used to enable researchers, public health professionals, and policy-makers to better understand and address the needs for cancer patients.

Registry data are critical for targeting programs focused on cancer risk including genetic, behavioral, and environmental risk factors. Such information is also essential for establishing and monitoring effective cancer screening and treatment. In addition, reliable registry data about patients is critical to research efforts, including research programs aimed at evaluating the effectiveness of cancer prevention, control, or treatment programs.

For hereditary cancers registries also play a very important role in determining

• causes of cancer among high-risk individuals
• who may or may not develop cancer
• better screening and preventive options for high-risk people.

Registries are a way for researchers to contact those in the high-risk community with updates about research or information about new studies and programs concerned specifically with hereditary cancer. Because populations of individuals with known hereditary mutations are rare, a registry can be a way to link those people with the research and resources they need to manage their risk.

Links to registries
Family Cancer Genetics Network Registry
A national registry for families affected by hereditary cancers. The website includes a form through which you can enroll in the registry online.

Cooperative Family Registry for Breast and Ovarian Cancer
An ongoing project that gathers information about families with a history of breast and/or ovarian cancer who volunteer to participate in this effort. This data is made available to qualified researchers without any accompanying information that can be used to personally identify the individuals or families involved.

Gilda Radner Familial Ovarian Cancer Registry
A registry for families affected by hereditary ovarian cancer.

Other websites
The website for research sponsored by the National Institute of Health

Clinical trials page from the National Coalition of Cancer Survivorship
Excellent overview of the types of clinical trials, patient protections and tips for finding relevant clinical trials.

National Cancer Institute (NCI)
Provides a comprehensive page on cancer clinical trials, including a publication on participating in clinical trials for cancer prevention.