The Basser Center for BRCA offers opportunities to participate in clinical trials and research studies focused on BRCA1 and BRCA2 mutations, hereditary cancer risk, cancer prevention, early detection, and treatment.
Clinical trials and research studies may be available for people with a BRCA mutation, a personal or family history of cancer, or other inherited genetic risk factors. Eligibility varies by study. Review the opportunities below to learn more about each study, including eligibility requirements and how to contact the research team.
What to Know Before You Explore:
What is a clinical trial?
A clinical trial is a research study involving people that evaluates a medical treatment, intervention, screening approach, or other healthcare strategy. Clinical trials can help researchers determine whether a new approach is safe and effective.
Why participate in a clinical trial or research study?
There are a number of reasons why patients enroll in clinical trials and clinical research studies related to hereditary cancer, such as:
- Gaining access to new experimental treatments or approaches that may not otherwise be available
- Having an opportunity to take a more active role in your healthcare
- Contributing to advancing science and medical care that may improve cancer prevention, detection, and treatment for people with hereditary cancer risk.
- Helping researchers better understand BRCA1 and BRCA2 mutations and other inherited cancer risk factors
Where can I learn more about open clinical trials at Penn Medicine or a research center near me?
- For more information, visit clinicaltrials.gov.
- For more information about breast cancer clinical trials at Penn Medicine, please reach out to BreastCancerClinicalTrials@pennmedicine.upenn.edu.
- For more information about pancreatic cancer clinical trials at Penn Medicine, please reach out to Patricia Gambino at Patricia.Gambino@pennmedicine.upenn.edu.
If you are a University of Pennsylvania or Penn Medicine employee and you have a PennKey log-in, you have access to the Penn Medicine Abramson Cancer Center Oncology Protocols Active List (ACC OPAL), a database of open and enrolling studies across many cancer types. Log in and access the portal here.
Open Clinical Trials at the Basser Center for BRCA:
Responses to Genetic Risk Modifier Testing Among Women with BRCA1/2 Mutations
Responses to Genetic Risk Modifier Testing Among Women with BRCA1/2 Mutations
Eligibility:
- BRCA1 or BRCA2 mutation carrier
- Female, 25 years of age or older
- Have not been diagnosed with breast cancer
- Have not had a prophylactic (preventative) mastectomy
- English-fluent
- Penn Medicine patient
About the Study:
This study is a collaboration with Memorial Sloan Kettering Cancer Center and Dana Farber Cancer Institute. Because of the variability in cancer risk estimates among BRCA1/2 carriers and the risks associated with surgery, a clinical genetic testing panel of genetic risk modifiers may have substantial clinical utility; it would reduce some of the uncertainty surrounding cancer risk estimates and could thus aid in decision-making regarding prophylactic mastectomy and other less invasive risk management strategies. However, it is unclear how women will ultimately perceive or respond to such novel risk information. The goal of this study is to determine the impact of genetic risk modifier testing, also called polygenic risk score or PRS, on BRCA1/2 mutation carriers’ decision making with respect to their intention to undergo prophylactic mastectomy or to pursue surveillance.
*This study is currently open to enrollment. For more information on this study, please contact Jamie Brower at jabrower@pennmedicine.upenn.edu.
eReach: A Randomized Study of an eHealth Delivery Alternative for Cancer Genetic Testing for Hereditary Cancer
Eligibility:
Individuals who meet the current National Comprehensive Cancer Network’s guidelines for testing.
About the study:
This study aims to determine if the web-based eHealth delivery of pre-test and/or post-test counseling in cancer patients and/or those at risk for cancer can provide equal outcomes when compared to the standard of care. eReach is a randomized study. Participants will have a 25% chance of being placed in one of four groups. Individuals throughout the country can participant in the eReach study. All study interventions, including genetic counseling, are provided by staff at the University of Pennsylvania.
For more information, visit the website or contact: Dominique Fetzer Dominique.Fetzer@pennmedicine.upenn.edu.
To assess if you are a candidate for genetic testing, this secure, HIPAA compliant Virtual Genetic Information Assistant ChatBot can help you learn if you meet criteria.
Olaparib Expanded: A Phase II Trial of Olaparib in Patients with Metastatic Breast Cancer and Mutations in DNA Repair Genes
Eligibility:
Patients with metastatic breast cancer and either an inherited (blood) mutation in a gene called PALB2 or a tumor (not inherited, not in the blood) mutation in BRCA1 or BRCA2.
About the Study:
This study is a phase II clinical trial looking at the effectiveness of the drug olaparib in patients who have metastatic breast cancer and specific gene alterations (“mutations”) either in their blood or in their tumors. The drug olaparib is a type of drug called a PARP inhibitor that is already FDA approved to treat patients with metastatic breast cancer associated with inherited (in blood) mutations in the BRCA1 and BRCA2 genes. Olaparib is thought to be effective in these patients because both olaparib and BRCA mutations disrupt the normal process of DNA repair, or the repair of a person’s genetic material. When a tumor cannot repair its own genetic makeup, errors accumulate, and cancer cells can die as a result. An earlier stage of this clinical trial showed olaparib also to help control cancer in patients with inherited PALB2 mutations or tumor-only BRCA mutations, and so the current stage of the trial is enrolling patients with those findings. This trial is open at the Basser Center / Abramson Cancer Center as well as other sites nationwide. The study team is happy to help evaluate whether or not you would be a candidate for this trial.
For more information please visit clinicaltrials.gov (NCT03344965) or contact Catherine Rudloff at 215-615-5329 or Catherine.Rudloff@pennmedicine.upenn.edu.
Research Registry: Identification and Analysis of Families With Genetic Susceptibility To Cancer
You are eligible for the Research Registry if any of the following apply to you:
- You or a family member have tested POSITIVE (pathogenic/likely pathogenic mutation) in BRCA1, BRCA2, PALB2 or other suspected cancer susceptibility genes and are willing to contribute a DNA sample (saliva or blood) AND can provide a copy of the laboratory result.
- You had negative genetic testing and have 2 close relatives on same side of the family with ovarian, breast, prostate and/or pancreatic cancer AND those relatives are available to contribute DNA samples (saliva or blood).
- You have ANY of the following personal history and are willing to contribute a DNA sample (saliva or blood)
- Breast cancer at age ≤ 40
- Bilateral breast cancer at age ≤ 60
- "Triple negative" breast cancer under age 60
- Male breast cancer diagnosed at any age
- Diagnosed with both primary breast and primary ovarian cancer at any age
- ≥ 2 primary cancers at age ≤ 70 (1 must be breast cancer and other cannot be a recurrence or nonmelanoma skin cancer or thyroid)
- Ovarian cancer at age ≤ 50
- Pancreatic cancer at age ≤ 50
- Metastatic prostate cancer at age ≤ 50
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@pennmedicine.upenn.edu, call 215.662.3182.
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.
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, 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.
SOROCk: NRG-CC008 A Non-Randomized Prospective Clinical Trial Comparing the Non-Inferiority of Salpingectomy to Salpingo-Oophorectomy to Reduce the Risk of Ovarian Cancer Among BRCA1 Carriers
Eligibility:
Patients with BRCA1 mutation that have elected to undergo the surgical removal of fallopian tubes (also known as bilateral salpingectomy or BLS) or removal of fallopian tubes and ovaries (also known as bilateral salpingo-oophorectomy or BSO).
About the Study:
This study is underway because researchers want to determine, for women with BRCA1 mutations who have completed childbearing, if there is a difference in outcomes between two surgical procedures that aim to reduce the risk of ovarian cancer. In this study, the removal of fallopian tubes will be compared to the removal of fallopian tubes and ovaries. The study will examine the factors that go into deciding which surgery to have and symptoms after surgery caused by lack of estrogen due to ovary removal.
This study is open to enrollment. For more information or to enroll, please contact Katherine Serratore, Katherine.Serratore@pennmedicine.upenn.edu.
Risk Reducing Salpingectomy with Delayed Oophorectomy as an Alternative to Risk-Reducing Salpingo-Oophorectomy in High Risk Women to Assess the Safety of Prevention
Eligibility:
- Women with BRCA1, BRCA2, RAD51C, RAD51D or BRIP1 germline mutation
- Childbearing completed
- Presence of at least one fallopian tube
About the Study:
The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
For more information contact Kristina Powell at Kristina.Powell@Pennmedicine.upenn.edu.
PATROL Study: Prostate Cancer Screening for People at Genetic Risk for Aggressive Disease
Eligibility:
- People with prostates ≥40 years of age
- Documented germline pathogenic variant in known or suspected genes associated with prostate cancer risk.
About the Study:
This study investigates ways to detect prostate cancer earlier in people at genetic risk for disease that forms, grows, or spreads quickly (aggressive). Studying samples of blood, urine, and/or tissue in the laboratory may help doctors further understand the genetics of prostate cancer and help identify ways to detect cancer earlier, thereby improving treatment and methods of early detection in the future.
For more information, contact patrol@pennmedicine.upenn.edu.