Clinical Trials

A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Phase III

This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2) -negative, PIK3CA-mutated, locally advanced (LA) or metastatic breast cancer (mBC), who progressed during or after cyclin dependent kinase 4/6i (CDK4/6i)-based therapy.

Start date: 2023-06-30.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-01628

Sacituzumab Govitecan and Pembrolizumab Therapy before Surgery for the Treatment of Immunochemotherapy-Resistant Early-Stage Triple-Negative Breast Cancer

A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-Resistant Early-Stage Triple-Negative Breast Cancer (TNBC)

Phase II

This trial includes triple negative tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase II trial studies the effect of giving sacituzumab govitecan in combination with pembrolizumab before surgery in treating patients with early stage triple-negative breast cancer that has not responded to a combination of immunotherapy and chemotherapy (immunochemotherapy-resistant). Sacituzumab govitecan is an antibody-drug conjugate which means it’s made up of an antibody attached to an anticancer drug. An antibody is a protein normally made by the immune system (the system in the body that fights off diseases). Sacituzumab govitecan may work by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion works to prevent tumor cells from growing/spreading. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving sacituzumab govitecan in combination with pembrolizumab may help to control early-stage triple negative breast cancer that has not responded well to other treatments.

Start date: 2023-05-23.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2022-10926

Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician’s Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy

Phase III

The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to current available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician’s choice (TPC) on progression-free survival (PFS).

Start date: 2023-05-08.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-04365

Trastuzumab Deruxtecan and Durvalumab Before Surgery for the Treatment of Patients with Stage III, HER2-Expressing Inflammatory Breast Cancer

TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab (MEDI 4736) for Stage III, HER2-Expressing Inflammatory Breast Cancer

Phase II

This phase II trial tests how well trastuzumab deruxtecan with durvalumab, given prior to surgery (neoadjuvant) works in treating stage III, HER-2 expressing inflammatory breast cancer. Trastuzumab deruxtecan is a monoclonal antibody called traztuzumab, linked to a chemotherapy drug called deruxtecan. 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 deruxtecan to kill them. Durvalumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Giving neoadjuvant trastuzumab deruxtecan with durvalumab may kill more cancer cells in patients with stage III, HER2 expressing inflammatory breast cancer.

Start date: 2023-05-04.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-03834

Stopping Anti-HER2 Therapy to Improve Outcomes for Exceptional Responder Patients with Metastatic HER2-Positive Breast Cancer, The STOP-HER2 Trial

The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab – Outcomes in Patients with HER2+ Metastatic Breast Cancer

Phase II

This trial includes Her-2 positive tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase II trial studies how well stopping anti-HER2 therapy works in improving outcomes of patients with HER2-positive breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and have experienced long-term benefit from first-line treatment (exceptional responders). Patients with metastatic HER2-positive breast cancer are currently treated with systemic drugs indefinitely. These drugs include chemotherapy and/or biological agents targeting the HER2 protein. The first drug combination administered after diagnosis of metastatic spread (i.e., first-line treatment) usually combines chemotherapy with anti-HER2 agents (trastuzumab with or without pertuzumab). Chemotherapy is administered for a limited number of months, and anti-HER2 agents are continued indefinitely as maintenance therapy. Some of these patients experience a long-term benefit from first-line treatment without cancer growth and can be defined as “exceptional responders.” Nevertheless, all patients with this type of tumor typically continue maintenance treatment with anti-HER2 therapy indefinitely. Exceptional responders usually receive treatment for many years. Information learned from this trial may help researchers understand whether maintenance anti-HER2 treatment can be safely stopped in patients with exceptional response to first-line therapy.

Start date: 2023-04-19.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-03485

Tumor Treating Fields for the Treatment of Leptomeningeal Metastases of the Spine in Patients with Breast Cancer

Pilot Feasibility Study of Tumor Treating Fields in Treatment of Leptomeningeal Metastases from Breast Carcinoma Involving the Spine

Phase NA

This clinical trial evaluates the safety and feasibility of tumor treating fields (TTF) in the treatment of spinal leptomeningeal disease in patients with breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic). Patients wear the portable Novo TTF-200T device that produces electric fields to target areas on the body to stop the growth of tumor cells. The information from this study will help researchers develop a better treatment for leptomeningeal metastases in the future.

Start date: 2023-04-07.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-00240

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients With ER+/HER2- Early Breast Cancer

Phase III

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 – early breast cancer with intermediate or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months.

Start date: 2023-03-31.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-03766

Dendritic Cell Vaccines against Her2/Her3 for the Treatment of Leptomeningeal Disease from Triple Negative Breast Cancer or HER2+ Breast Cancer

A First in Human Dose Escalation of Dendritic Cell Vaccine (DCV) Administered Intrathecally (IT) Primed against HER2/HER3 in Patients with Leptomeningeal Disease (LMD) from Triple-Negative Breast Cancer (TNBC) or HER2+ Breast Cancer (HER2+BC)

Phase I

This trial includes triple negative tumors, which are very rare among men with breast cancer. Please check your eligibility.

This phase I trial tests the safety, side effects, and best dose of dendritic cell vaccines against Her2/Her3 in treating patients with triple negative breast cancer or HER2+ breast cancer that has spread to the brain and spinal cord tissue (leptomeningeal metastasis). Dendritic cell vaccines work by boosting the immune system (a system in the body that protect against infection) to recognize and destroy the cancer cells. The dendritic cell vaccine is made utilizing blood cells collected from a procedure called leukapheresis. Infusing dendritic cell vaccines directly into the thin fluid-filled space between the lining of the spinal cord and brain via a surgically implanted reservoir under the scalp (Ommaya reservoir) may cause a stronger immune response, and may kill more tumor cells.

Start date: 2023-03-28.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-03180

Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer

Phase I_II

Incyclix Bio (Incyclix) is developing INX-315 as an oral, small molecule inhibitor of cyclin dependent kinase 2 (CDK2) for the treatment of human cancers. This first-in-human study is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary antitumor activity of INX-315 in patients with recurrent advanced/metastatic cancer, including hormone receptor positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) breast cancer who progressed on a prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) regimen, and CCNE1-amplified solid tumors who progressed on standard of care treatment. This study will evaluate approximately 6 dose levels of daily INX-315 in Part A, at least two dose levels will be evaluated in Part B to identify the Recommended Phase 2 Dose (RP2D) in patients with ovarian cancer, and Part C will evaluate combination treatment of INX-315 plus a CDK4/6i and selective estrogen receptor degrader (SERD) in HR+/HER2- breast cancer patients who have progressed on prior CDK4/6i regimen.

Start date: 2023-03-28.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-04176

Tamoxifen and Alpelisib Compared to Fulvestrant and Zotatifin for the Treatment of Newly Diagnosed or Recurrent Estrogen Receptor Positive, HER2 Negative Breast Cancer

An Umbrella, Randomized, Controlled, Pre-Operative Trial Testing Integrative Subtype-Targeted Therapeutics in Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Phase II

This phase II trial compares the effect of combination therapy with alpelisib and tamoxifen vs. tamoxifen alone and combination therapy with zotatifin and fulvestrant vs. fulvestrant alone in patients with estrogen receptor (ER) positive, HER2-negative breast cancer that is newly diagnosed or has come back (recurrent). Breast cancer survival rates in early stage, ER positive, HER2 negative breast cancer have improved with modern oncology management, but a significant number of patients eventually develop distant recurrence and die from cancer that has spread from where it first started (primary site) to other places in the body (metastatic) disease. Tamoxifen and fulvestrant are in a class of hormone therapy medications known as antiestrogens. They block the activity of estrogen (a female hormone) in the breast. This may stop the growth of some breast tumors that need estrogen to grow. Alpelisib is in a class of medications called kinase inhibitors. It works to treat cancer by blocking an enzyme called PI3K that signals tumor cells to multiply. By inhibiting this enzyme, it helps to stop the spread of tumor cells. Zotatifin is a selective inhibitor of a family of proteins called eIF4A. It may prevent the growth of tumor cells and may kill them. This trial will help researchers determine whether combination therapy with tamoxifen and alpelisib or fulvestrant and zotatifin may be more effective than hormone therapy alone in treating patients with estrogen receptor positive, HER2-negative breast cancer.

Start date: 2023-03-20.

This trial is being offered at including in the following states:

For more information including sites offering the trial visit this NCI page: NCI-2023-02578