Three new studies are focus of Breast Cancer Awareness Month

This year, the American Cancer Society estimates about 287,850 new cases of invasive breast cancer will be diagnosed in women in the United States. Over 43,000 women will die from the disease, making breast cancer the second-leading cause of cancer-related death in women after lung cancer. 

October is Breast Cancer Awareness Month and considering these statistics it’s important to recognize the role research plays in lowering the number of new diagnoses and breast cancer deaths each year.  

Clinical trials are an essential component of research. As an evidence-based approach, clinical trials rely on patient participants and researchers who explore or examine the safety and efficacy of medications and strategies that could become tomorrow’s life-saving treatment for breast cancer.  

In support of Breast Cancer Awareness Month, we’re featuring three clinical studies offered by the Earle A. Chiles Research Institute, a division of Providence Cancer Institute of Oregon, for people with HER2-neu negative breast cancer. All trials are currently recruiting patients.   

Phase III trial to evaluate combination medications in patients with ER-positive, HER2-negative breast cancer  

The purpose of this placebo-controlled trial is to evaluate the efficacy and safety of a new oral medication against the estrogen receptor called GDC-9545 (giredestrant) combined with palbociclib, compared to palbociclib with letrozole in patients with locally advanced or metastatic hormone positive breast cancer. This is a randomized, double-blind, study where all participants get palbocicilib and an endocrine therapy. 

In 2015, the Food and Drug Administration (FDA) approved palbociclib in combination with letrozole for the treatment of estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative advanced breast cancer as an initial endocrine-based therapy in postmenopausal women. The FDA approval followed a clinical trial (PALOMA-2) that reviewed the combination of palbociclib plus letrozole or placebo plus letrozole. Study results showed the palbociclib/letrozole combination was more effective in treating ER-positive, HER2-negative metastatic breast cancer than letrozole plus placebo. 

However, patients still relapse on this therapy due to endocrine resistance. This trial will provide an opportunity for researchers to study if GDC-9545 with palbociclib is more effective for patients with regard to progression-free survival.  

GDC-9545 is a selective estrogen receptor degrader (SERD) that specifically targets and binds to the estrogen receptor and inhibits both the growth and survival of cancer cells. In preclinical trials, GDC-9545 has shown to be a full antagonist, effective at binding to and blocking the stimulating effect of estrogen on tumor cells.  

Providence Cancer Institute is currently recruiting participants for this study. Alison Conlin, M.D., MPH, medical director, Providence Breast Cancer Medical Program, is the principal investigator. Providence Cancer Institute is the only location in Oregon currently recruiting for this clinical trial. 

Get the full trial details here: 

Phase III Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of GDC-9545 Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Patients With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer 

Phase III placebo-controlled trial to study chemotherapy plus pembrolizumab versus chemotherapy with placebo HR+/HER2- locally recurrent inoperable or metastatic breast cancer   

This clinical trial will evaluate the safety and efficacy of pembrolizumab plus the investigator's choice of chemotherapy compared to placebo plus the investigator's choice of chemotherapy. The trial is for patients with hormone receptor (HR)-positive, HER2-negative locally recurrent inoperable or metastatic breast cancer. Participants are candidates for chemo (no prior chemo for metastatic disease) with PD-L1 CPS ≥1 and documented progression on prior endocrine therapy. 

Study looks at chemo-immunotherapy combination 

Pembrolizumab is an immunotherapy administered to patients whose cancer has the PD-L1 protein and has come back and cannot be removed by surgery or has spread. The medication works by blocking the PD-1 pathway, thereby helping T cells find and attack cancer cells. 

Chemotherapy is used in treating breast cancer to:  

  • Kill cancer cells 
  • Prevent cancer from coming back after surgery and radiation 
  • Shrink a tumor before surgery to make it easier to remove 

Researchers hypothesize that the combination of pembrolizumab and chemotherapy is a superior treatment to placebo and chemotherapy regarding progression-free survival or overall survival in participants who meet the study criteria. 

This is a randomized, double-blind trial, which means patients are randomly assigned to different groups to receive different treatments and neither the participant nor the researcher knows this information.  

The Earle A. Chiles Research Institute currently is recruiting for this trial led by medical oncologist David Page, M.D., Providence Cancer Institute. Get the full study details here:  

Study of Pembrolizumab (MK-3475) Plus Chemotherapy Versus Placebo Plus Chemotherapy for HR+/HER2- Locally Recurrent Inoperable or Metastatic Breast Cancer (MK-3475-B49/KEYNOTE-B49) 

A dose escalation/expansion study of oral OP-1250 in people with advanced and/or metastatic HR+, HER2- breast cancer 

This clinical trial studies a new type of oral estrogen blocking drug,  OP-1250, a complete estrogen receptor antagonist (CERAN). OP-1250 blocks the receptor where estrogen would stimulate the growth of breast cancer cells. It is hoped that this agent will stop tumor cells from growing and spreading. 

In August 2022, the FDA granted a fast-track designation to OP-1250 for the treatment of patients with ER-positive, HER2-negative metastatic breast cancer. In a preclinical study, it was shown that OP-1250 blocks and destroys the estrogen receptor, which led to a response in the tumor. 

The current clinical trial will continue to evaluate the potential of OP-1250 in patients with hormone -positive, HER2-negative metastatic breast cancer who previously have been treated with endocrine agents, CDK4/6 inhibitors, and even chemotherapy.  

Phase I/II trial is open-label and two-arm 

The phase II arm of the study is now open with recommended dosing and will further explore the clinical activity, safety and effects of OP-1250, and evaluate for anti-tumor efficacy. 

This clinical trial is offered at sites worldwide. Providence Cancer Institute is one of five sites in the U.S. recruiting patients for the trial. 

Alison Conlin, M.D., MPH, medical director, Providence Breast Cancer Medical Program and High-Risk Breast Cancer Clinic, is the principal investigator. 

Get the full trial details here: 

A Phase I Dose Escalation and Dose Expansion and Phase II Monotherapy Open-label, First-in-Human, Multicenter Study of OP-1250 in Adult Subjects with Advanced and/or Metastatic Hormone Receptor (HR)-positive, HER2-negative Breast Cancer 

To refer a patient to any of these clinical trials, contact our clinical research office:   

New research studies are added frequently. To see more clinical studies, visit:  

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A multidisciplinary team of breast cancer specialists  

Providence Cancer institute offers a comprehensive, multidisciplinary approach to breast care. Achieving optimal breast health and providing world-class treatment for breast cancer are equal priorities in our continuing goal to improve women's health.   

Our clinical and research teams include dedicated surgeons for breast cancer and breast reconstruction oncologists who specialize exclusively in breast cancer, as well as breast-cancer-focused nurse navigators and research nurses, genetic specialists, nutrition counselors, oncology social workers, laboratory scientists, data coordinators and lab assistants. Every person on this team is passionate about providing the best possible care and the best available treatments for people with breast cancer.  

To learn more, visit Providence Breast Cancer Program. 

Related news 

Two studies assess combination treatments for advanced breast cancers 

Creating Hope 2022 introduces next generation of immunotherapy 

New clinical studies for invasive breast cancer 

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