Reasons to Participate in a Clinical Trial

There are a number of reasons why patients enroll in clinical trials and clinical research studies related to hereditary cancer.

  • Patients can gain access to new experimental drugs or treatments
  • Patients are interested in having a more active role in his or her healthcare
  • Patients are interested in advancing science and medical care and improving the understanding of hereditary cancer risks
     

By participating in clinical trials and research studies, participants help advance what is known about medical interventions and cancer risks.

BRCA Founder Outreach Study (BFOR)

Eligibility:

The study will offer BRCA genetic testing to women and men of Ashkenazi (Eastern European) Jewish ancestry, age 25 or older, located in the New York, Boston, Philadelphia, and Los Angeles metropolitan areas. This model combines the convenience of direct-to-consumer genetic tests along with the advantages of receiving testing with the guidance of a medical care provider. BFOR offers BRCA genetic testing at no cost to participants.

Click here to participate in the study.

Research Registry: Identification and Analysis of Families With Genetic Susceptibility To Cancer

You are eligible for the Registry if any of the following apply to you:

  • You or a family member have any of the following types of mutations:
    1. BRCA1 or BRCA2, or a BRCA1/2 variant of uncertain significance
    2. A gene mutation or variant linked to a heritable gastrointestinal syndrome (such as Lynch Syndrome)
  • An inherited mutation or variant in another cancer risk gene
  • Personal diagnosis of breast cancer at age 40 or below
  • Personal diagnosis of bilateral breast cancer under age 60
  • Personal diagnosis of "triple negative" breast cancer under age 60, DCIS excluded (triple negative breast cancer is estrogen receptor negative, progesterone receptor negative, Her2/neu negative)
  • Personal diagnosis of breast cancer at any age with three or more breast cancers under age 70 in first, second, or third degree relatives on the same side of the family
  • Male breast cancer diagnosed at any age
  • Personal diagnosis of ovarian cancer under age 50
  • Personal diagnosis of ovarian cancer at any age and one relative with ovarian cancer diagnosed under age 50
  • Personal diagnosis of breast cancer under age 60 and a first, second, or third degree relative with ovarian cancer diagnosed at any age
  • Personal diagnosis of multiple primary cancer (breast and ovarian cancers) at any age
  • Personal diagnosis of breast cancer under age 70 and a first, second, or third degree relative with multiple primary cancer (breast and ovarian cancers) at any age
  • Personal diagnosis of breast cancer at any age and a second primary cancer, both diagnosed under age 70.  The second primary cancer cannot be a recurrence or metastasis of the breast cancer and cannot be skin cancer, with the exception of melanoma.
  • Personal diagnosis of pancreatic cancer under age 50
  • Personal diagnosis of pancreatic cancer at any age and at least one first or second degree relative with breast or pancreatic cancer diagnosed under age 50
  • Personal diagnosis of metastatic prostate cancer or Gleason score of 8 or higher
  • Personal diagnosis of prostate cancer (Gleason score of 7 or higher) and at least one first or second degree relative with breast, pancreatic, or ovarian cancer
     

About the Study:
The research laboratory at the Abramson Cancer Center is studying genetic sources of cancer risk and currently has one of the largest collections (also called a registry) of families with known or suspected risk in the world. Participation involves providing medical and family history, key medical records, and a DNA saliva sample. There are no costs associated with participation and all arrangements can be made over the telephone or through the mail. Travel to the University of Pennsylvania is not necessary for participation.


If you have any questions, please contact us by emailing BasserResearch@uphs.upenn.edu, call 215.662.3182, or fax 215.614.1609.

Click here to participate in this study and enroll in the Research Registry.

A number of research projects are performed in collaboration with this registry. Research participants receive a numerical identification number that protects their privacy. Collaborating centers do not have access to personal identifiers such as names and dates of birth because only the numerical identifiers are shared. Specific research projects are listed below:

CIMBA (The Consortium of Investigators of Modifiers of BRCA1/2)
CIMBA is an international group of investigators representing 28 countries focused on studying many issues related to inherited BRCA1/2. One main area is the identification of modifier genes. That is, genes other than BRCA1 and BRCA2 that may impact cancer risk in mutation carriers.

BRIDGE (BRCA1/2 International Diversity by Geography and Ethnicity)
Most women (95%) who participate in BRCA1/2-related research are of Caucasian and Jewish ancestry. Through the BRIDGE study investigators hope to increase participation of underrepresented groups of women in BRCA1/2 research. Through studying this underrepresented population, researchers hope to provide clinically relevant information about BRCA1/2 mutations by ethnicity and geography and improve risk assessment and an understanding of modifiers of risk in these populations.

For more information, contact Melissa Batson or call 215.360.0420.

A Randomized, Phase 2 Study of the Efficacy and Tolerability of Veliparib in Combination with Temozolomide or in Combination with Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin Paclitaxel in Subjects with BRCA1 or BRCA2 Mutation and Metastatic Breast Cancer

Eligibility:

  • BRCA1 or BRCA2 mutation or advanced stage breast cancer


About the Study:
Veliparib is a medication classified as a "PARP inhibitor". PARP inhibitors are being studied to treat cancers in those who carry genetic risk due to either BRCA1 or BRCA2. These medicines are designed to address the biology of tumors arising due to mutations in either gene, and represent a new type of tailored therapy. This study is examining veliparib in combination with different type of chemotherapy compared to chemotherapy alone.

For more information, please visit clinicaltrials.gov or call Robin Holmes, RN at the University of Pennsylvania, at 215.615.0360.

A Phase II, Open Label Study of Rucaparib in Patients with Advanced Pancreatic Cancer and a Known Deleterious Germline or Somatic BRCA1, BRCA2 or PALB2 Mutation

Eligibility:

  • Patients with a known BRCA1, BRCA2, or PALB2 mutation (either in blood or tumor) with inoperable (locally advanced or metastatic) pancreatic adenocarcinoma who have achieved tumor stability on platinum-based treatment (FOLFIRINOX, FOLFOX or cisplatin/gemcitabine) for at least 4 months. 
     

About the Study:
The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the drug rucaparib on you and on your pancreatic cancer. We also hope to learn more about how this drug works on your specific disease and what might predict resistance to treatment. Rucaparib belongs to a class of anti-cancer agents known as PARP inhibitors. PARP is a protein inside cells in the body that helps repair damage to DNA, which is the genetic material that carries the instructions for your body’s growth and development. Cancer can result from changes in a person’s genetic material (sometimes called DNA mutations) and some of these changes can cause cancer cells to grow out of control. Research has shown that PARP inhibitors stop the PARP protein from working, and that can sometimes cause cancer cells to stop growing. This is particularly true for patients with specific mutations in the DNA of their tumors, such as BRCA or PALB2 mutations.

For more information please visit clinicaltrials.gov or call Colleen Redlinger at 215.220.9693.

Cancer Risk Evaluation Program (CREP) Biobank

Eligibility:

  • Older than 18 years of age and documented mutation in BRCA1, BRCA2, TP53, PTEN, MLH1,MSH2, MSH6, or PMS2.


About the Study:
The goal of this repository of specimens and data is to identify blood biomarkers associated with the early development of cancer or cancer recurrence. Investigators hope that this will lead to the creation of new screening tests in individuals at high risk for breast and ovarian cancer. Participation in this study involves an annual blood draw throughout a patient's lifetime. Currently, the blood sample can only be drawn at the University of Pennsylvania in Philadelphia. If you are already being seen at the Rena Rowan Breast Center, this appointment can be scheduled at the same time as your annual check-up.

For more information, contact Melissa Batson or call 215.360.0420.

Prospective Registry of Multiplex Testing (PROMPT)

Eligibility:

  • Individuals who have had multigene (also known as multiplex) panel genetic testing and tested positive for a mutation or variant of uncertain significance in at least one cancer susceptibility gene other than BRCA1/2.


About the Study:
PROMPT is an online registry that is a collaborative effort between academic researchers at the Basser Research Center for BRCA, Dana Farber Cancer Center, the Mayo Clinic, and Memorial Sloan Kettering Cancer Center. The purpose of PROMPT is to provide patients, physicians, and researchers with an opportunity to share information about multiplex genetic testing so that we can all better understand the implications of these genetic mutations.

For more information, email Jamie Brower at prompt@uphs.upenn.edu. You can also visit the information page for PROMPT at promptstudy.info.