Saint John’s Cancer Institute’s, Dr. Parvin Peddi, is the principal investigator in 4 new targeted therapy clinical trials for breast cancer

Targeted therapy is a type of cancer treatment that “targets” cancer cells without affecting normal cells. Targeted therapy is the foundation of precision medicine; medicine based on an individuals genes. That is to say, it is medicine made specifically for you versus a general population group.1,2

Dr. Parvin Peddi specializes in the treatment of patients with breast cancer, who designs, implements, and leads clinical trials to test new or novel targeted therapies.  Dr. Peddi is board certified in internal medicine and medical oncology and is the Director of Breast Medical Oncology and Assistant Professor of Medical Oncology at the Margie Peterson Breast Cancer Clinic at Providence Saint John’s Health Center. Her research has been published in various medical journals including the New England Journal of Medicine.

Dr. Peddi is the principal investigator in 4 new and actively enrolling clinical trials at Saint John’s Cancer Institute for targeted therapies in breast cancer patient populations.

Testing Sacituzumab Govitecan Therapy in Patients With HER2-Negative Breast Cancer and Brain Metastases

This phase II trial studies the effect of sacituzumab govitecan in treating patients with HER2-negative breast cancer that has spread to the brain (brain metastases). Sacituzumab govitecan is a monoclonal antibody called sacituzumab, which is linked to govitecan⁠—a chemotherapy drug. Sacituzumab is a form of targeted therapy because it attaches to specific molecules on the surface of cancer cells, known as Trop-2 receptors, and delivers govitecan to kill them. Giving sacituzumab govitecan may shrink cancer in the brain and/or extend the time until the cancer gets worse.

Open to HR+ and HR- patients. Progression of disease after CNS directed therapy or before CNS directed therapy. Evidence of crossing of blood-brain barrier with this agent.

T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial

Cooperative group phase III study of a combination of tucatinib + T-DM1 vs. T-DM1 in HER2+ breast cancer patients with residual disease post neoadjuvant chemotherapy and surgery (CompassHER2 RD). This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapse) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody called trastuzumab that is linked to a chemotherapy drug referred to as DM1.

Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2-positive breast cancer compared to T-DM1 alone.

Study to Evaluate the Safety and Efficacy of Magrolimab in Combination With Nab-Paclitaxel or Paclitaxel Versus Nab-Paclitaxel or Paclitaxel in Previously Untreated Adults With Metastatic Triple-Negative Breast Cancer

The primary objective of this phase II study for the Safety Run-In Cohort is to evaluate the safety, tolerability, and recommended Phase 2 dose (RP2D) of magrolimab in combination with nab-paclitaxel or paclitaxel in metastatic triple-negative breast cancer (mTNBC). This is a novel immunotherapy approach targeting macrophage checkpoints.

The primary objective of this study for the Randomized Cohorts is to evaluate the efficacy of magrolimab in combination with nab-paclitaxel or paclitaxel in solid tumors as determined by progression-free survival (PFS) by investigator assessment.

Study Evaluating Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients w/ Locally Advanced or Metastatic HR+/HER2- Breast Cancer

A Phase Ib/III study to evaluate the efficacy and safety of the combination therapy with afuresertib plus fulvestrant in Phase III) in patients with HR+/HER2- breast cancer who have failed 1 to 2 prior lines of endocrine therapy, and/or CDK4/6 inhibitor (up to 1 therapy), and/or chemotherapy (up to 1 chemotherapy) as described in the inclusion criteria.

Eligible patients for this study must have either;
  • progressive disease whilst receiving endocrine therapy, and/or a CDK4/6 inhibitor (controls cell cycle progression) for locally advanced or metastatic disease.
  • relapsed with metastatic disease whilst receiving an ET (AI or SERM), and/or a CDK4/6 inhibitor, and/or chemotherapy in the adjuvant setting.

The Phase Ib part is a single-arm, open-label, “proof-of-concept” study to evaluate anti-tumor efficacy, safety, tolerability, and pharmacokinetics of the combination therapy with afuresertib plus fulvestrant. Twenty patients will be enrolled in this part.

The Phase III part is a multi-center, randomized, double-blind, placebo-controlled, pivotal study with two parallel treatment arms to further assess the anti-tumor efficacy and safety of afuresertib combined with fulvestrant (experimental arm).

These kinds of targeted therapy trials hopefully will translate into precision medicine, or rather, “personalized medicine,” one day.

Transforming biomedical research and medicine into promising new treatments that can be used clinically starts here at Saint John’s Cancer Institute.

What is translational precision medicine research and who benefits?

Translational precision medicine research is the means that will bridge the sciences and the clinical fields together, and indicates a pendulum shift in how medicine is becoming more and more patient-centric. According to the Journal of Personalized Medicine, “translational research is a rapidly evolving area of biomedical research that aims to facilitate and speed up the transfer of scientific discoveries into clinical practice… Precision medicine is the ultimate goal of personalized medicine… A milestone in precision medicine evolution [was] reached in 1998 with the approval of the first matched drug and diagnostic test for monoclonal antibody trastuzumab in breast cancer patients overexpression HER2 protein.”

The people who most benefit from targeted therapies or precision medicine have been cancer patients; patients who have been through every available treatment and none have worked.3

To be a part of a clinical trial please contact: 310-582-7448

Watch for a closer look into how precision medicine translates into patient-centric care at Saint John’s Cancer Institute.

 

Resources:

  1. Traditional vs. Precision Medicine: How They Differ
  2. Targeted Cancer Therapies
  3. Translational Research in the Era of Precision Medicine: Where We Are and Where We Will Go

About the Author

Eleanor Zeri