research & clinical trials
Clinical trials and research
Overview
Research is the best way for the medical community to discover better methods to detect, prevent, or treat cancer, or to improve quality of life. As the only national nonprofit advocacy organization focused on hereditary breast and ovarian cancer, FORCE has a strong commitment to promoting research to benefit our community by advocating for more research funding, helping researchers enroll people into research studies, educating people about available research studies, and broadcasting new and relevant research findings back to our community.
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.
New research findings
Periodically we will feature summaries of new research results that are relevant to our community. Check back frequently for new reports.
PARP Inhibitor research presented at ASCO 2009 Annual Conference:
Three promising but early research studies on a class of drugs called PARP Inhibitors which may work preferentially for hereditary cancers were presented at the 2009 American Society of Clinical Oncology Annual Conference last week in Orlando.
One session presented results from a clinical trial for breast cancer patients with "triple-negative" cancers: cancers which do not express estrogen receptors, progesterone receptors, or the Her2neu protein. This study is particularly relevant to our community since "triple negative breast cancers" are the most common type of breast cancer in BRCA 1 mutation carriers. Approximate 85% of BRCA 1 mutation carriers who have breast cancer have triple negative disease.Some BRCA2 carriers and women with non-hereditary breast cancer (especially African-American women) also develop triple-negative disease.
This randomized phase II study looked at the BiPar Sciences PARP Inhibitor BSI 201 in women with triple negative breast cancer which had metastasized (spread beyond the breast and lymph nodes). Women in the study with metastatic breast cancer were chosen randomized to be in one of two groups: one group that received the chemotherapy combination Gemcitabine and Carboplatin and the other group that received those two chemotherapies in combination with the PARP Inhibitor BSI 201 as an intravenous injection. Three times as many women in the PARP inhibitor arm of the study had improvement of their cancer compared to those who received chemotherapy alone. Women on the arm of the study that included PARP inhibitors went about 3 ½ months longer on average than those on chemotherapy alone without their disease progressing and lived about 3 ½ months longer on average than those on chemotherapy alone. Also the group that received the PARP Inhibitors along with the chemotherapy had no higher side-effects than the group on chemotherapy alone.
A second study investigated the AstraZeneca PARP Inhibitor drug formerly known as AZD2281 and now known by the name “olaparib." This phase II clinical trial studied women with known BRCA 1 or BRCA 2 mutations and metastatic breast cancer. In this study the PARP Inhibitor was given as a “single agent” (ie- with no other treatment) to women who had already received previous courses of chemotherapy and had progression of their cancer on prior treatments. Olaparib is an oral medication and women in the study were given one of two doses: a low dose (100 mg 2 times/day) or a high dose (400 mg 2 times/day). The higher dose led to one woman having a complete response (ie-there was no measurable cancer during treatment) and 10 partial responses (the cancer was measurably smaller or did not increase) for an overall response rate of 41%. The response rate with the lower dose was 22%. Most of the side effects were not severe and included primarily fatigue and nausea. Women who responded favorably to treatment included women with BRCA 1 and women with BRCA 2 mutations suggesting that the medication works for both mutation carrier populations. This particular study used the PARP Inhibitor alone. The presenters reported on one woman in the study who had lung metastasis and is still on the medication whose cancer has not progressed in the 18 months since she started the study.
A third study similar to the one presented above investigated olaparib for advanced ovarian cancer in BRCA mutation carriers. This phase II clinical trial studied women with known BRCA 1 or BRCA 2 mutations and recurrent ovarian cancer. In this study the PARP Inhibitor was given as a “single agent” (ie- with no other treatment) to women who had already received several previous courses of chemotherapy and had progression of their cancer on prior treatments. As in the breast cancer study, women in this trial were given one of two doses: a low dose (100 mg 2 times/day) or a high dose (400 mg 2 times/day). 33 were evaluable at 400 mg bd and 24 at 100 mg bd. The overall response rate was 33% at the higher dose(400 mg twice daily) and 12.5% at 100 mg twice daily dose. Of the women on the high dose, 58% experienced clinical benefit and 17% of the women on the lower dose experienced clinical benefit. Side effects were mild, and included nausea (44%); fatigue (35%); and anemia (14%). More serious side effects were rare and comprised primarily of nausea and low white blood cells. The researchers showed that olaparib is well tolerated and active in women with advanced ovarian cancer.
Although exciting, there is more research that is needed. Larger (phase III) studies will help show if PARP inhibitors can extend the life of women with advanced cancer. Future studies on women with early stage disease will be needed to determine if these medications might be used to prevent recurrence in women with early stage cancer.
Currently there are some open PARP inhibitor studies for women with BRCA mutations and cancer but not many.
Active Research Studies
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.
Help test a decision aid for breast cancer prevention
A paper-based decision aid about breast cancer prevention has been developed for women with the BRCA1 or BRAC2 mutation. The goal of this decision aid is to help women to make decisions about breast cancer prevention. It is very important that before it is widely distributed we assess if it is useful for women who have recently received their genetic test results. Dr Kelly Metcalfe and Dr. Steven Narod from the University of Toronto, are doing a study to test this and are looking for volunteers to participate. The study is a randomized controlled trial where half the participants receive the decision aid and the other half do not.
If you have received your genetic test results within the past 3 months, are between 25 and 60 years old, are not currently pregnant and have no history of cancer you may be eligible. The study is conducted entirely by phone and involves 4 interviews each taking 10-15 minutes. The first interview occurs when you join the study and the others are 3, 6 and 12 months later. The interviews are scheduled at your convenience.
If you are interested in participating or receiving more information please contact the trial coordinator Julie Weston at julie.weston@utoronto.ca or 416-946-8677 (call collect).
Active 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
- Ovarian cancer surveillance trials
- Ovarian cancer prevention trials
- Pancreatic cancer surveillance trials
- Prostate cancer screening trial for men with BRCA mutation
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:
- Stanford PARP Inhibitor breast cancer study for women with triple-negative, newly diagnosed breast cancer; Meredith Mills Project Manager, (650) 724-5223 or e-mail bluett@stanford.edu
A new Phase III clinical trial using PARP Inhibitors in combination with chemotherapy just opened at multiple sites across the United States for women with advanced (stage IV) breast cancer. The agent BSI-201 is one of the agents used for the Phase II study which reported positive results at ASCO. The study is open in 66 sites across the country. For more information on enrollment criteria contact BiPar Sciences at (866) 668-2232 or email clinicaltrials@BiParSciences.com.
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.
A new Phase III clinical trial for triple-negative breast cancer using PARP Inhibitors in combination with chemotherapy just opened at multiple sites across the United States for women with advanced (stage IV) breast cancer. The agent BSI-201 is one of the agents used for the Phase II study which reported positive results at ASCO. The study is open in 66 sites across the country. For more information on enrollment criteria contact BiPar Sciences at (866) 668-2232 or email clinicaltrials@BiParSciences.com.
Other treatment studies
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
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.
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.
Prospective Study of Nipple-Sparing Mastectomy; Oncologic and Reconstructive Outcomes
The trial is being done to determine whether the nipple-areola complex can be preserved during mastectomy while maintaining an oncologically safe procedure. It will also study post-operative nipple healing, short and long-term reconstructive surgery outcomes, and patient satisfaction following nipple-sparing mastectomy.
Registry of Mastectomy for Breast Cancer Risk Reduction
This registry is open to high-risk women undergoing prophylactic mastectomy at Georgetown University Hospital.
Other websites
ClinicalTrials.gov
The website for research sponsored by the National Institute of Health
http://www.canceradvocacy.org/resources/
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.