Closed for Enrollment

• A Phase 1, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of SGN-LIV1A in Patients With Metastatic Breast Cancer Rochester, Minn.

  This study will examine the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.

• A Phase 2/3, Multi-Center, Open-Label, Randomized Study of Weekly Nab®-Paclitaxel in Combination With Gemcitabine or Carboplatin, Compared to Gemcitabine/Carboplatin, as First Line Treatment in Subjects With ER, PgR, and HER2 Negative (Triple Negative) Metastatic Breast Cancer Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to compare the safety and efficacy of nab-paclitaxel in combination with either gemcitabine or carboplatin to the combination of gemcitabine and carboplatin as first line treatment in female subjects with triple negative metastatic breast cancer (TNMBC) or metastatic triple negative breast cancer.

• A Phase II Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy for Metastatic Triple-Negative Breast Cancer (mTNBC) - (KEYNOTE-086) Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to examine the effectiveness and safety of pembrolizumab as first line or above treatment in patients with metastatic triple-negative breast cancer. 

• A Phase II Randomized, Double-blind Placebo Controlled, Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women With Hormone Receptor-positive HER2-negative Breast Cancer Rochester, Minn.

  The purpose of the study is to determine whether treatment with a PI3K inhibitor plus letrozole leads to an increase in pathologic clinical response and Objective Response Rate compared to treatment with placebo plus letrozole in patients with Breast cancer

• An Open-Label, Single-arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients Rochester, Minn.

  This is an open-label, single-arm pilot study evaluating the antitumor activity and safety of niraparib as neoadjuvant therapy in patients with HER2 negative and BRCAmut localized breast cancer (primary tumor >1 cm).

• COMETI Phase 2: Characterization of Circulating Tumor Cells (CTC) From Patients With Metastatic Breast Cancer Using the CTC-Endocrine Therapy Index (COMETI P2) Rochester, Minn.

  Utilizing CellSearch® technology, the ability to both enumerate and reliably and reproducibly characterize circulating tumor cells (CTC) for tumor markers that predict endocrine sensitivity (estrogen receptor [ER] and Bcl-2) and resistance (HER2 and Ki67) has been demonstrated. An algorithm for a CTC-Endocrine Therapy Index (CTC-ETI) has been constructed that can be calculated for each patient using the CTC enumeration and marker results. The primary goal of this study is to determine a CTC-ETI in ER positive, HER2 negative metastatic breast cancer patients before the initiation of a new endocrine therapy for the identification of patients that will progress rapidly.

• Evaluation of ctDNA Diagnostics with Magnetic Nanoparticle Enabled Automated Sample Preparation Rochester, Minn.

  The purpose of this study is to to establish a minimally-invasive blood based test for the detection of clinically actionable genetic changes in breast cancer patients.

• Impact of DNA/RNA Sequencing Results on the Clinical Management of Patients with Advanced Malignancies Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to assess practice patterns and changes in treatment recommendations based on the results obtained from a clinically available, comprehensive next generation DNA/RNA sequencing assay. A database of paired clinical and sequencing data will also be established for future research.

• MK-3475-756 - A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER/HER2-) Breast Cancer (KEYNOTE-756) Rochester, Minn.

  The purpose of this study is to assess the effectiveness and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

• The PATHFINDER Study: Assessment of the Implementation of an Investigational Multi-Cancer Early Detection Test Into Clinical Practice (PATHFINDER) Rochester, Minn.

  The purpose of this study is to evaluate an investigational, multi-cancer early detect test developed by Grail, Inc. with the results returned to a study investigator.

   

• The STRIVE Study: Breast Cancer Screening Cohort for the Development of Assays for Early Cancer Detection La Crosse, Wis., Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz., Eau Claire, Wis.

  GRAIL is using high-intensity sequencing of circulating cell-free nucleic acids (cfNAs) to develop blood tests to detect cancer early. The purpose of this study is to train and validate an assay to detect invasive breast cancer in patients undergoing mammography.