Clinical Trials Breast Cancer

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Clinical Trials

Our Current Clinical Trials are Listed Below:

Phase II Trial to Evaluate Immune-related Biomarkers for Pathological Response in Stage II-III Her2-positive Breast Cancer Receiving Neoadjuvant Chemotherapy with Subsequent Randomization to Multi-epitope Her2 Vaccine Vs. Placebo in Patients with Residual Disease Post-neoadjuvant Chemotherapy

This study is looking at a new way to treat a specific type of breast cancer called Her2-positive breast cancer. Patients with HER2 positive cancer who have undergone chemotherapy prior to surgery and after surgical intervention they still have residual disease in the breast would be eligible to participate in this study. Patients will receive a vaccine that targets a protein called Her2, which is found on the surface of cancer cells) along with standard of care ado-trastuzumab emtansine (TDM-1) to prevent cancer from recurring. A control group of patients will receive a placebo instead of the vaccine along with the standard of care, TDM-1. The purpose of this study is to find out if this multi-epitope HER2 peptide study vaccine in addition to the standard of care will prevent cancer from recurrence.  Also in this study researchers are looking into certain markers in the patients' immune system to find out why some HER2 positive breast cancer patients are responding well to chemotherapy in combination with targeted anti-HER2 therapies like trastuzumab and pertuzumab and some do not. The goal of the study is to find new ways to treat Her2-positive breast cancer and improve outcomes for patients.

Principal Investigator: Sima Ehsani, MD

Phase II trial of DNA-guided second line adjuvant therapy for high residual risk, Stage II-III, estrogen receptor +, HER2-Negative breast cancer -2102467313

DARE is a study that aims to improve treatment for a specific type of breast cancer which is estrogen receptor positive, HER2 negative and in patients who are at high risk of recurrence after receiving standard treatment.

Cancer cells often release DNA molecules into the blood. DNA is the material of the genetic code of cancer cells. Cancer cells have many alterations (called mutations) in their DNA compared to normal cells. The purpose of this research is to find out if detecting cancer-related abnormal DNA molecules (called circulating tumor DNA, or ctDNA) in the blood after completing standard treatment can predict a subsequent clinical recurrence of the cancer. 

The study has two main parts. The first part is the screening phase which involves blood draws every 6 months to look for the ctDNA. The goal of this phase is to see how often ctDNA is found in the blood of patients who are receiving standard treatment but are still at high risk of recurrence.

The second part of the study is called the therapeutic randomized phase which is offered to those who have ctDNA in their blood (ctDNA positive). In this phase, patients undergo further workup and imaging to ensure they have no signs of cancer recurrence. If these workup and imaging studies reveal cancer recurrence in any organ, the patient will no longer be part of this study, and will receive appropriate treatment through their treating physician. If patients have no evidence of cancer in other organs, then researchers will test a new treatment called palbociclib plus fulvestrant to see if it improves the chances of staying cancer-free compared to standard treatment.  

The study also has other aims and objectives. These include estimating how often patients have signs of cancer when ctDNA is first detected, and how well ctDNA predicts future cancer relapse. Researchers will also look at whether clearing ctDNA from the blood is associated with better outcomes, and whether the new treatment improves ctDNA clearance, as well as other measures of cancer-free survival.

The study will also assess the safety and tolerability of the new treatment. Finally, researchers will store blood samples for future research, which may include studying the biology of metastatic breast cancer and identifying potential new treatments.

Principal Investigator: Sima Ehsani, MD

Hoosier Cancer Research Network HCRN BRE20-468 - A Phase II Study of Ribociclib And Endocrine Treatment of Physician’s Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer (RaPhLRR Study)

This is a research study in patients with breast cancer which has returned in the same breast as the original cancer or in a lymph node or chest wall near the original cancer. This is called a local recurrence. Patients with local recurrence are at higher risk of recurrent cancer again either in the same area or spreading to other organs. The researchers want to find out if they can lower the chance of breast cancer coming back again by adding a drug called ribociclib to the usual hormone therapy drugs. 

Patients with estrogen receptor (ER) positive and/or progesterone receptor (PR) positive and HER-2-negative subtype of breast cancer can participate in this study. The usual approach for patients who are not in a study is to receive surgery +/- radiation therapy, followed by hormone therapy. Hormone therapy (also called endocrine therapy) are drugs that either lower estrogen levels or block estrogen receptors on breast cancer cells. Participants in this study will receive a drug called ribociclib in addition to endocrine therapy that the oncologist is recommending. During this study, patients will have tests, exams and procedures that are part of regular care and for study purposes. Also as part of routine care, patients will be evaluated every 4 to 12 weeks to make sure the cancer hasn’t come back. Ribociclib will be prescribed for up to 3 years. After that patients will continue endocrine therapy alone for another 2 years (5 years total) as part of your regular care. 

Ribociclib has already been approved by the FDA for this type of cancer that has not been removed by surgery or has spread to other parts of the body. It is also being evaluated in early-stage breast cancer in addition to hormonal therapy in patients who are at high risk of recurrence. This drug could be associated with some side effects that would require monitoring and visits with the oncologist. 

Principal Investigator: Sima Ehsani, MD

A First-in-Human Study of Mutant-selective PI3K5; Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination with Fulvestrant in Patients With Advanced Breast Cancer

Researchers are testing a new drug called RLY-2608 on people with advanced solid tumors and advanced breast cancer. The drug targets a specific type of protein called PI3K5, which is mutated in some cancer cells. This study looks at how well the drug works on its own verses how it works when combined with another drug called Fulvestrant. This is the first time the drug is being tested in humans.

Principal Investigator: Jennifer M. Segar, MD

Double Blind Trial Investigating the Role of Sulfasalazine in Decreasing Opioids Requirements in Breast Cancer Patients 

Cancer in general, and breast cancer specifically, is a significant health problem in the USA and the rest of the world. With the improvement of new surgical approaches and chemotherapies to treat and manage breast cancer, the number of patients with breast cancer are now living longer.  This great achievement created an unexpected problem.  For some breast cancer patients, pain is worse than the cancer itself. The golden standard to manage pain is opioids.  Breast cancer patients are now taking ever-increasing doses of opioids to control their pain.  Sadly, opioids come with significant side effects.  

These side effects limit the amount of opioids that can be safely administered.  Many attempts have been made to create better pain control regimens to lower the need for opioids.  There has not been significant success in that area.  A better approach to better control breast cancer pain and lower the amount of opioids used would be to add a non-opioid agent that has dual mechanisms of action.  This may create synergism to control pain better while lowering the doses of opioids needed and lowering side effects.  

Sulfasalazine poses such quality.  It is a safe anti-inflammatory drug with an established safety profile.  It has been used for over fifty years to treat inflammatory conditions such as rheumatoid arthritis.  In addition to its anti-inflammatory characteristics, sulfasalazine has the capacity to decrease the survival of cancer cells and also to lower the amount of inflammatory mediators released by cancer cells. In short, sulfasalazine inhibits the influx of cysteine into cancer cells and the efflux of glutamate.  Cysteine is needed for cell survival against oxidative stress, while glutamate activates pain receptors.

Therefore, sulfasalazine will act as an anti-inflammatory agent to accelerate cancer cell death and decrease the released glutamate, which activates pain receptors.  This one agent with three mechanisms of action may lower the amount of opioids needed for cancer patients while maintaining or improving their pain control.  Lowering opioid dosing may also improve the side effects associated with opioid use. In this study patients are randomly assigned into two groups. All patients would continue their pain medications as prescribed by their treating physician and at their baseline.

One group is being treated with sulfasalazine in addition to their baseline opioids. The second group will receive placebo in addition to their opioids. Placebo is a pill that appears to be a medical treatment but is not. All patients will be monitored for potential side effects of the drug and to evaluate for their pain, to characterize the pain and opioid use.  

Our hypothesis is that adding sulfasalazine to the pain medication regimen would lower the amount of opioids used and lower the side effects.  This may improve the quality of life for breast cancer patients and decrease the risks of using high doses of opioids for the patients, their families, and society in general. 

Principal Investigator: Mohab Ibrahim, MD, PhD

EA1181 (CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response

The main goal of this study is to find out if patients with HER2-positive breast cancer who have stage II or IIIa cancer, and are treated with targeted HER2 targeted treatment and chemotherapy before surgery and have no residual cancer at the time of surgery have a better chance of the cancer not coming back after three years.  Patients will receive 12 weeks of treatment with a combination of drugs, followed by surgery and additional therapy. The study will also look at other outcomes, such as overall survival, cancer recurrence, and safety and tolerability of the treatment.

Overall, this study aims to improve our understanding of how to treat early stage HER2-positive breast cancer and improve outcomes for patients.

Principal Investigator: Jennifer M. Segar, MD

Phase 2 single center, two arm study to evaluate the change in chemotherapy induced peripheral neuropathy (CIPN) with the addition of hydroxychloroquine to chemotherapy in patients with early stage breast cancer (study not open yet)

Chemotherapy can be part of the treatment regimen to treat early-stage breast cancer. Paclitaxel is one of the chemotherapies commonly used. Paclitaxel can cause peripheral neuropathy or nerve damage. This can significantly impact patients’ quality of life. This study is looking to see if hydroxychloroquine can be used to help treat chemotherapy induced peripheral neuropathy. Hydroxychloroquine is already used currently to treat malaria and certain rheumatological conditions. Hydroxychloroquine will be given during the course of the chemotherapy. Patients will be asked to complete questionnaires and have blood drawn while on the study.     

Principal Investigator: Jennifer M. Segar, MD