Breast Cancer Clinical Trials & Research at St. Joseph Health Medical Group

In the U.S., breast cancer is the second most common cancer in women after skin cancer. It can occur in both men and women. The most common type of breast cancer is ductal carcinoma, which begins in the cells of the ducts. Breast cancer can also begin in the cells of the lobules and in other tissues in the breast. Invasive breast cancer is breast cancer that has spread from where it began in the ducts or lobules to surrounding tissue.

St. Joseph Health Medical Group is currently enrolling patients for the following breast cancer clinical trials:

A Phase III, Randomized, Double-blind, Placebo Controlled Study of Adagloxad Simolenin (OBI-822)/OBI-821 Treatment for High Risk Early Stage Triple Negative Breast Cancer Patients, defined as Residual Invasive Disease following Neoadjuvant Chemotherapy OR ≥ 4 Positive Axillary Nodes (JIT OBI-822)

Phase III

The goal of this study is to prospectively evaluate the efficacy and safety of adagloxad simolenin (OBI-822)/OBI-821 treatment, compared to placebo, in patients with early stage Triple Negative Breast Cancer at high risk for recurrence. The study population includes patients with locally confirmed Estrogen Receptor (ER)-negative, Progesterone Receptor (PR)-negative, and Human Epidermal Growth Factor Receptor (HER)2-negative (triple-negative) cancer of the breast. High risk patients will be enrolled after excision of the primary cancer, surgical evaluation of the axillary nodes and completion of the assigned (adjuvant or neoadjuvant) treatment. Surgical margins are required to be free of invasive disease and ductal carcinoma in situ (DCIS).

Treatment agent: OBI-822/OBI-821
PI: Thomas Stanton, MD
Study Coordinator: Kim Young // Kimberly.Young@stjoe.org // (707) 521-3814
Resources and Links: clinicaltrials.gov NCT No: NCT03562637

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC trial.

Phase III

The primary objective of this trial is to compare the effect of aspirin versus placebo upon invasive disease free survival in early stage node-positive HER2 negative breast cancer patients. Eligible patients will be randomized according Hormone Receptor status (HR positive vs HR negative), body mass index and stage (Stage II vs III). Patients are followed up to 10 years after study enrollment.

Treatment agent: Asparin
PI: Thomas Stanton, MD
Study Coordinator: Camille Shaffer // Camille.Shaffer@stjoe.org // (707) 521-3809
Resources and Links: clinicaltrials.gov NCT No: NCT02927249

A Phase II, Multicenter, Randomized Study To Compare the Efficacy of Venetoclax Plus Fulvestrant Versus Fulvestrant In Women With Estrogen Receptor−Positive, Her2−Negative Locally Advanced or Metastatic Breast Cancer Who Experienced Disease Recurrence or Progression During or After Cdk4/6 Inhibitor Therapy (Roche Breast)

Phase II

The goal of this study is to evaluate the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with estrogen receptor-positive (ER+), human epidermal growth factor receptor (HER2)-negative, locally advanced breast cancer not amenable to surgical or local therapy with curative intent or with metastatic breast cancer who experienced disease recurrence or progression during or after being treated with cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy for at least 8 weeks prior to progression.

Treatment agent: Fulvestrant +/- venetoclax
PI: Thomas Stanton, MD
Study Coordinator: Camille Shaffer // Camille.Shaffer@stjoe.org // (707) 521-3809
Resources and Links: clinicaltrials.gov NCT No: NCT03584009

A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane (JIT Odonate)

Phase III

The goal of this study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival in patients with HER2 negative, HR positive locally advanced/metastatic breast cancer previously treated with a taxane in the neoadjuvant or adjuvant setting. Patients will be treated until documentation of progressive disease, evidence of unacceptable toxicity, or other decision to discontinue treatment.

Treatment agent: Tesetaxel +/- capecitabine
PI: Thomas Stanton, MD
Study Coordinator: Kim Young // Kimberly.Young@stjoe.org // (707) 521-3814
Resources and Links: clinicaltrials.gov NCT No: NCT03326674

Palbociclib (IBRANCE) in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional Study (POLARIS)

Registry Study

This Non-Interventional Study will describe and analyze the clinical use of palbociclib in routine clinical practice in the treatment of advanced breast cancer. HR+/HER2- advanced breast cancer patients whose treatment decision with palbociclib has been made by their treating physician and who meet the eligibility criteria will be invited to participate in the study. Study duration will consist of approximately 2 years of recruitment and 3 years of follow-up post each patient’s end of treatment with palbociclib. All treatment decisions, type and timing of disease monitoring are at the discretion of treating physician and patient.

Treatment agent: N/A
PI: Thomas Stanton, MD
Study Coordinator: Camille Shaffer // Camille.Shaffer@stjoe.org // (707) 521-3809
Resources and Links: clinicaltrials.gov NCT No: NCT03280303

A Phase I/IIa Study of the SV-BR-1-GM Regimen in Metastatic or Locally Recurrent Breast Cancer Patients in Combination with Ipilimumab or Pembrolizumab (BriaCell Rollover)​

Phase I/IIa

The purpose of this study is to gather preliminary data to evaluate the safety, tolerability, and feasibility of SV-BR-1-GM therapy for advanced breast cancer using an allogeneic breast tumor cell line transfected with the GM-CSF gene (SV-BR-1-GM) when given in combination with ipilimumab (for patients with PD-L1/2- tumors) or pembrolizumab (for patients with PD-L1/2+ tumors). This experimental therapy is being evaluated in a small initial cohort with qualifying stage IV breast cancer. SV-BR-1-GM is preceded by low dose intravenous cyclophosphamide to reduce suppressor T cells, and the SV-BR-1-GM inoculated by intradermal injections with subsequent local injection of low-dose Interferon-alpha-2b.

Treatment agent: SV-BR-1-GM + Ipilimumab or Pembrolizumab
PI: Jarrod Holmes, MD
Study Coordinator: Sabine Ucik // Sabine.Ucik@stjoe.org // (707) 521-3830
Resources and Links: clinicaltrials.gov NCT No: NCT03328026

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