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. 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

BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to determine the Preventative Effect of Denosumab on Breast Cancer in Women carrying a BRCA1 Germline Mutation.

Eligibility:

  • Females ages 25-55
  • Deleterious or likely deleterious germline BRCA1 mutation
  • No prior history of breast or ovarian cancer
  • No planned preventative breast surgery

About the study:

This research study is being conducted to evaluate the reduction in the risk of any breast cancer (invasive or ductal carcinoma in situ [DCIS]) in women with germline BRCA1 mutation who are treated with denosumab compared to placebo.

For more information, contact Alexandra Torres Alexandra.torres@pennmedicine.upenn.ed

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.

Phase 1b Study of INO-5401 Alone or INO-5401 in Combination with INO-9012 Followed by Electroporation in Adult Cancer and Non-Cancer Patients with BRCA1 or BRCA2 Mutations

Eligibility:

  • Females and males age 18+
  • Females must be post-menopausal
  • Group B currently enrolling:
    • Carrier of a pathogenic or likely pathogenic mutation in BRCA1 or BRCA2 with no prior history of cancer

About the study:
The research study is being conducted to test an experimental vaccine to potentially prevent cancer for people with BRCA1 or BRCA2 mutations. This study will test if the vaccine is safe (without significant side effects) and test a new way of administering vaccines. It will also test whether the vaccine activates your immune system.

Learn more about this study by watching Dr. Susan Domchek's interview on Fox29 here. 

For more information, contact Alexandra Torres at alexandra.torres@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.

Combination ATR and PARP Inhibitor (CAPRI) trial with ceralasertib (AZD6738) and olaparib in recurrent ovarian cancer

Eligibility:
All patients must have recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer.  Most but not all cohorts include only high grade serous ovarian, but one cohort includes other subtypes.  The cohorts have different requirements regarding prior platinum sensitivity and are exploring different dosing schedules of the two investigational drugs.  Patients can have any or no BRCA or other mutations. 

About the study: 
The main purpose of this study is to learn how effective a new anti-cancer treatment combination is in controlling your recurrent ovarian cancer.  The treatments are olaparib (a PARP inhibitor that is already an FDA approved medication for ovarian cancer) and ceralasertib (aka AZD6738, an ATR inhibitor, a targeted therapy that is being developed). Both drugs target the process of repairing damage to your genes, which is precisely the problem in patients who have mutations in BRCA and other DNA repair genes. There is no placebo and this is a phase II study, which means all patients will receive both drugs at the same doses that have already been shown to be generally safe. We also hope to understand why this drug works in some patients and not in others, so you will also be asked to have tumor biopsies. If the treatment works and seems safe for you, you will have the opportunity to stay on it until you decide otherwise.

For more information please visit clinicaltrials.gov and type “NCT03462342” into the “Other Terms” field or contact Shavon Rochester at Shavon.Rochester@Pennmedicine.upenn.edu .

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
    • Multiple primary breast and 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, or fax 215.349.5314.

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.

For more information on the research the registry contributes to, read our latest Research Registry newsletter from September 2023.

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.  

Preliminary Evaluation of Screening for Pancreatic Cancer in Patients With Inherited Genetic Risk

Eligibility: 

Patients with germline pathogenic or likely pathogenic BRCA1, BRCA2, ATM, or PALB2 mutation and age 50 years or older. 

About the Study: 

This study is a prospective study evaluating the utility of endoscopic ultrasound (EUS) or MRI for the identification of pancreatic lesions in patients at high risk for pancreatic cancer, specifically those with BRCA1, BRCA2, PALB2, and ATM mutations.  A family history of pancreatic cancer is not required for study participation.

For more information visit clinicaltrials.gov/ct2/show/NCT02478892, or contact study coordinator Daniel Clay at Daniel.Clay@Pennmedicine.upenn.edu or 215-360-0905, or study PI Dr. Bryson Katona at bryson.katona@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 Christine Pae at christine.pae@pennmedicine.upenn.edu.

NePtune Study: Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With BRCA1/​2 Gene Alterations

Eligibility: 

  • Male, 18 years of age or older
  • Written informed consent and HIPAA authorization for release of personal health information prior to registration.
  • T stage 1-3 prostatic adenocarcinoma per AJCC staging manual Ed8.
  • Histologically confirmed adenocarcinoma of the prostate without histological variants comprising >50% of the sample. Patients with intraductal carcinoma are eligible.
  • Must have 3 core biopsies involved with cancer (a minimum of 6 core biopsies must be obtained). Prostate biopsy must be within 7 months from registration. Less than 3 core biopsies are allowed if the patient has >1 cm or T3 disease on magnetic resonance imaging (MRI).
  • Localized unfavorable intermediate or high-risk prostate cancer patients. Patients must have at least one of the following features:
    • Gleason ≥ 4+3 (grade group 3, 4, 5) OR
    • PSA > 20 ng/dL OR
    • T3 disease NOTE: Patients with intraductal carcinoma are eligible independent of Gleason score, PSA and T stage.
  • Must have evidence of germline or somatic BRCA1/2 gene alteration via standard of care CLIA based assay detection. Testing will be confirmed centrally but results of central testing not required for enrollment.
  • No evidence of metastatic disease  
  • Lymph nodes must be less than 20 mm in the short (transverse) axis.
  • Participants must be candidates for RP and considered surgically resectable by urologic evaluation.
  • ECOG Performance Status of 0-1 within 28 days prior to registration.

About the Study: 

In this study, patients will receive treatment with olaparib + LHRH agonist. Following 6 months of therapy, patients will undergo RP with mandatory lymph node dissection. The lymph node dissection template will be at the discretion of the treating urologist. RP specimens will undergo pathology blinded independent central review. Following RP, patients will be followed for testosterone recovery and PSA progression.

For more information contact Jennifer Louie at jennifer.louie2@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.