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 & improving the understanding of hereditary cancer risks
     

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

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

Eligibility:

  • Mutation positive for:
    1. BRCA1 or BRCA2, or a BRCA1/2 variant of uncertain significance
    2. A gene mutation linked to a heritable gastrointestinal syndrome (such as Lynch Syndrome)
    3. An inherited mutation in another cancer risk gene
  • Personal diagnosis of breast cancer under age 40
  • Personal diagnosis of bilateral breast cancer under age 50
  • Personal diagnosis of "triple negative" breast cancer under age 60 (Triple negative breast cancer is estrogen receptor negative, progesterone receptor negative, Her2/neu negative)
  • Personal diagnosis of ovarian cancer at any age
  • Personal history of breast or ovarian cancer at any age and at least one family member with breast or ovarian cancer
  • Personal history of breast cancer at any age and a second primary cancer (A second primary cancer is a second cancer diagnosis that is not related to your first cancer diagnosis. It is not a recurrence or metastasis of your original diagnosis of breast cancer. The second primary cannot be skin cancer except melanoma.)
  • Male breast 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.

Click here to participate in this study.

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, call Pamela Kline at 215.662.2748.

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 eitherBRCA1 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.

Prevention and Observation of Surgical Endpoints (The PROSE Study)

Eligibility:

  • BRCA mutation carriers enrolled in the Identification and Analysis of Families With Genetic Susceptibility To Cancer study below will be included in PROSE.


About the Study:
Investigators at the University of Pennsylvania are leading an international collaborative effort studying the effects of risk reducing surgery such as removal of the ovaries and prophylactic mastectomy for women who carry genetic risk due to BRCA1 and BRCA2. In addition, the group is studying the impact of hormone replacement therapy in women who undergo early menopause due to surgical removal of the ovaries. Specific aims currently include an examination of the effects of hormone replacement therapy for women who undergo early menopause due to surgical removal of the ovaries. The group is also studying how the timing of surgery with respect to age and reproductive history may ultimately affect cancer risks.

For more information, call Pamela Kline at 215.662.2748.

A Study of hTERT Immunotherapy Alone or in Combination with IL-12 DNA

Followed by Electroporation in Patients with Breast, Lung, or Pancreatic Cancer at High Risk of Relapse Post Definitive Surgery and Adjuvant Therapy
Eligibility:

  • Individuals with Stage III or Stage II/axillary node positive disease who are status post definitive surgery and at least 4 and no more than 24 weeks from completion of definitive chemotherapy and/or radiation adjuvant therapy at the time of signing informed consent (for ER+ or Her2+ positive patients, these patients may continue on hormonal therapy or anti-Her2 therapy as per standard of care);
  • Subjects with ER/PR/HER2 negative breast cancer (triple negative) of any stage who are status post  definitive surgery but with residual microscopic breast cancer in surgical specimen following neoadjuvant chemotherapy if given; patient may be at least 4 and no more than 24 weeks from completion of adjuvant therapy (e.g. radiation) at the time of signing informed consent;
  • History of neoadjuvant therapy is allowed. A subject receiving ongoing adjuvant endocrine (e.g. tamoxifen, anastrazole) therapy or trastuzumab is allowed.
     

About the Study: 
This study is being done to test an experimental vaccine therapy for your type of cancer as well as a new way of administering this vaccine.  This experimental vaccine therapy is being tested in people who have received "standard of care" treatment, which includes surgery, radiation therapy and chemotherapy. The vaccine (a single vaccine made up of two parts, called INO-1400 and INO-9012) will be injected into your muscle using a study device (called CELLECTRA-5P). The purpose of this study is to check the safety of INO-1400 by itself or in combination with INO-9012 and the research device and to test its effects on the immune system. This study will look at the effects of the study vaccine given up to 4 separate times and will look at the potential/possible side effects. The study staff will also do tests to see if the study vaccine has any effect on the evolution of your cancer (whether your cancer comes back, and if so if your disease is better or worse than before).

For more information, contact Maryann Redlinger or 215.662.7452.

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 Chan Voong or call 215.662.2771 or Claudia Yepez-Laubach or call 215.360.0422.

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.