Available Clinical Trials

The following clinical trials are being conducted:

Trial

(iCaRe2)Protocol Title: Integrated Cancer Repository for Cancer Research

The iCaRe2 is a unique sociotechnical resource for the collection and management of cancer and health-related data.

The objectivesof this project is to implement and maintain a comprehensive data and biospecimen bank known as the Integrated Cancer Repository for Cancer Research (iCaRe2). The data registry and biospecimen bank will provide core support services for multidisciplinary research on cancer and other chronic diseases carried out by internal and external research collaborators from different participating institutions/centers.

(COMET Trial)AFT-25

The Comparison of Operative to Monitoring and Endocrine Therapy for Low RiskDCIS (COMET) study is a clinical trial that looks at different treatment choices for ductal carcinoma in situ (also called DCIS).

DCIS is a non-invasive breast condition where cells that do not appear to be normal are found in the milk ducts. These cells are often harmless and may not need treatment.

The goal of this study it to find out if some women can safely avoid surgery and radiation and their possible side effects which include pain, infection, scarring, and other changes to the breasts. However, active surveillance may not have equal or better outcomes than standard care treatments and there is a chance that your DCIS may change over time.

(GH101)Genetic Susceptibility and Management of Chronic Disease

The objective of this study is to take an integrative approach to the fields of cancer genomics and mRNA microarrays. These disciplines have evolved from the original human genome project but have essentially remained discreet. The integration of these genetic disciplines into a computational model has the potential to increase diagnostic yield and provide a clearer genetic picture to determine actionable events to improve healthcare.

(PrecisionMed)Collection of Blood, Urine and Tissue Samples from Patients with Solid Malignant Tumors

This multi-site protocol is designed to collect blood, urine and tissue (fresh and FFPE) as well as clinical data from donors with solid malignant tumors including, but not limited to NSCLC, breast cancer, hepatocellular carcinoma, pancreatic cancer, prostate cancer and colorectal cancer. Samples as well as clinical information are de-identified. In addition, clinical data willbe collected over the course of the disease for up to a five year period. There may also be intermittent collection of blood and urine samples over the 5 year period.

(iTeos)

A randomized, double-blind, placebo-controlled, Phase 2 study evaluating efficacy and safety of inupadenant in combinationwith carboplatin and pemetrexed as a second-line therapy in adults with metastatic nonsquamous non-small cell lung cancer

This study is designed to achieve 2 main objectives: a) assess the safety and tolerability of the combination of inupadenant HCl and carboplatin/pemetrexed in an open label, dose-finding part to determine the appropriate RP2D dose of inupadenant HCl in combination with carboplatin/pemetrexed in the randomized Part 2 portion of the study and b) assess the efficacy of inupadenant HCl and carboplatin/pemetrexed compared to a control arm receiving matching placebo to inupadenant HCl and carboplatin/pemetrexed in a second-line mNSCLC population.

(Genentech)ML43171

A PhaseIII, randomized, open-label, multicenter study evaluating the efficacyandsafetyofgiredestrant pluseverolimuscompared withexemestane pluseverolimusin patients with estrogen receptor-positive,HER2-negative, locally advanced or metastatic breast cancer.

This study will evaluate the efficacy and safety of giredestrant plus everolimus compared with exemestane plus everolimus in patients with estrogen-receptor positive (ER+), human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer. Specific objectives and corresponding endpoints for the study are outlined below. In this protocol, "study treatment" refers to the combination of treatments assigned to patients as part of this study (i.e., giredestrant plus everolimus or exemestane plus everolimus).

(OVELIA)OVarian Suppression Evaluating Subcutaneous LeuprolIde Acetate in Breast Cancer:

A Phase 3, Single Arm, Open-Label Study Evaluating Ovarian Suppression Following Three-Month Leuprolide Acetate For Injectable Suspension (TOL2506) in Combination with Endocrine Therapy inPremenopausal Subjects with Hormone-Receptor Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

Objectives: Primary:To assess suppression of ovarian function following administration of TOL2506 in premenopausal subjects with HR+, HER2-negative breast cancerSecondary:

• To assess safety and tolerability of TOL2506 in premenopausal subjects with HR+, HER2-negative breast cancer
• To assess the pharmacokinetics (PK) and pharmacodynamics (PD) of TOL2506 following administration in premenopausal subjects with HR+, HER2-negative breast cancer

(ICAN NC) mHealth behavioral cancer pain intervention for medically undeserved patients

The efficacy of a mobile health (mHealth) behavioral cancer pain intervention designed to decrease pain and disability for breast cancer patients inmedically underserved areas has not been investigated. The long-term goal of this work is to use mHealth technologies to facilitate wide-spread implementation of an efficacious behavioral cancer pain intervention -a non-pharmacological approach to pain management. The proposed project's objective is to demonstrate the efficacy of an innovative mobile health Pain Coping Skills Training (mPCST-Community) designed to meet the needs of breast cancer patients with pain in medically underserved areas.

(WB ABCs)Well-Being After Breast Cancer Surgery

ImprovingWell-Beingfor Individuals With Persistent Pain After Surgery for Breast Cancer, Lobular Carcinoma in Situ, or Ductal Carcinoma in Situ: A Randomized Clinical Trial That Compares Three Behavioral Intervention Strategies and Examines Psychological Factors as Drivers of the Continuing Burden of Persistent Pain.

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