Cancer

Learn more about cancer

Cancer: Disease Overview

Nearly 1.8 million Americans will learn that they have cancer this year. There are more than 200 forms of this often devastating disease, which are characterized by the uncontrolled and destructive growth of cells. Cancer is currently the second leading cause of death in the United States, and BRI is committed to finding out what causes it and how to better treat and prevent it.

Laboratory scientists are investigating the connections between autoimmune diseases and the mechanisms that help cancer grow and spread without being detected by the immune system. Clinical trials are studying cancer from a variety of angles, including prevention and treatment.

What Is Cancer?

Cancer is an umbrella term for a variety of diseases in which abnormal cells divide uncontrollably. These cells can invade nearby tissues and also spread to other parts of the body through the blood and lymph systems (known as metastasizing). Cancer can affect just about any part of the body. Biomedical advances over the past 50 years have vastly improved the treatments and outcomes for people facing cancer.

What Causes Cancer?

Cancer is caused by changes to genes that control the way cells function, especially the way they grow and divide. Usually, the immune system eliminates cells with damaged DNA. In the case of cancer, the immune system fails to recognize the cancerous cells and they can grow uncontrolled within the body.

What Are Risk Factors for Cancer?

Scientists still don’t know why one person develops cancer and another does not. However, research has shown that certain factors can increase a person’s chances of developing cancer.

  • Age – Older people are more likely to develop cancer.
  • Health habits – Smoking, drinking alcohol, obesity, excessive exposure to the sun and unsafe sex can all increase the chance of developing cancer.
  • Family history – Though cancer is not passed down from one generation to the next, gene mutations that increase the risk of cancer can be. Not everyone who has a specific gene mutation will develop cancer. 
  • Health conditions – Some chronic conditions, such as ulcerative colitis, can increase the risk of cancer.
  • Environmental exposures – Exposure to harmful chemicals, such as secondhand smoke, asbestos, benzene, etc., can increase the risk of cancer. 

What Is the Latest Research Into Cancer?

BRI is a leader in understanding the interaction between immune system function and the development of cancer. Our current research includes:

  • Unraveling how cancer cells stop the immune system from recognizing tumors as dangerous.
  • Pinpointing the links between cancer and autoimmunity.
  • Using artificial intelligence (AI) and data analytics to identify new targets for treatment.
  • Understanding the cells and processes that allow cancer to advance.

Clinical Research Studies in Cancer

We have ongoing clinical research studies in several areas of cancer research. Studies labeled as “Enrolling” are actively accepting new participants while studies labeled as “Closed to Enrollment” are still active but no longer seeking new participants.

 

Please email Cancer Clinical Research or call (206) 287-6270 for more information.

 

Breast Cancer

A Phase 3, Randomized, Open-Label, Multicenter Trial of Arv-471 Vs Fulvestrant in Participants with Estrogen Receptor-Positive, Her2-Negative Advanced Breast Cancer Whose Disease Progressed After Prior Endocrine Based Treatment for Advanced Disease
Principal Investigator: Meaghan O'Malley, MD
Status: Enrolling

Intra-Operative Radiotherapy after breast conserving therapy in the treatment of early stage breast cancer
Principal Investigator: Huong Pham, MD
Status: Enrolling

 


A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Breast Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A PHASE III CLINICAL TRIAL COMPARING TRASTUZUMAB GIVEN CONCURRENTLY WITH RADIATION THERAPY AND RADIATION THERAPY ALONE FOR WOMEN WITH HER2-POSITIVE DUCTICAL CARCINOMA IN SITU RESECTED BY LUMPECTOMY
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Phase III, Randomized Clinical Trial of Standard Adjuvant Endocrine Therapy +/- Chemotherapy in Patients with 1-3 Positive Nodes, Hormone Receptor-Positive and HER2-Negative Breast Cancer with Recurrence Score (RS) of 25 or Less
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Randomized Phase III Trial of Adjuvant Therapy Comparing Chemotherapy Alone (Six Cycles of Docetaxel Plus Cyclophosphamide or Four Cycles of Doxorubicin Plus Cyclophosphamide
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A RANDOMIZED, PHASE III TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF MK-3475 (PEMBROLIZUMAB) AS ADJUVANT THERAPY FOR TRIPLE RECEPTOR-NEGATIVE BREAST CANCER WITH ≥ 1 CM RESIDUAL INVASIVE CANCER OR POSITIVE LYMPH NODES (ypN+) AFTER NEOADJUVANT CHEMOTHERAPY
Principal Investigator: Meaghan O'Malley, MD
Status: Closed to Enrollment

Elacestrant monotherapy vs. standard of care for the treatment of patients with ER+/HER2- advanced breast cancer following CDK4/6 inhibitor therapy: a phase 3 randomized, open-label, active-controlled, multicenter Trial (EMERALD)
Principal Investigator: Meaghan O'Malley, MD
Status: Closed to Enrollment

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk Hormone Receptor-Positive and Her2/Neu Negative Breast Cancer
Principal Investigator: Nanette Robinson, MD
Status: Closed to Enrollment

Cancer Non-Specific

A Phase 1/1b Study of ASP2074 in Participants with Metastatic or Locally Advanced Solid Tumors
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A prospective observational cohort study to assess miRNA 371 for outcome prediction in patients with newly diagnosed germ cell tumors
Principal Investigator: John Paul Flores, MD
Status: Enrolling

Characterization of the peripheral blood signature in patients treated with PD1/PDL-1 Checkpoint Inhibitors
Principal Investigator: John Paul Flores, MD
Status: Enrolling

EA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III TrialEA2197: Optimal Perioperative Therapy For Incidental Gallbladder Cancer (OPT-IN): A Randomized Phase II/III Trial
Principal Investigator: Bruce Lin, MD
Status: Enrolling

Secondary Use Donor Derived APL sample requested by Stanford investigator - Molecular, Antigenic, and Genetic Characterization of Inflammatory and Neoplastic Cellular Subsets in Hematopoietic Neoplasms
Principal Investigator: Russell Dorer, MD
Status: Enrolling 

Virginia Mason Medical Center and Benaroya Research Institute Tumor Tissue Repository (VM-BRITE) Sample Collection Protocol
Principal Investigator: Christopher Gault, MD 
Status: Enrolling

 


GRAIL-001 The Circulating Cell-free Genome Atlas (CCGA) Study
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

Phase III Trial of Radiotherapy Plus Cetuximab versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Program for the assessment of clinical cancer tests (PACCT-1):  Trial assigning individualized options for treatment:  The TAILORx Trial
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Colorectal Cancer

A multi-site, open-label, Phase II, randomized, controlled trial to compare the efficacy of RO7198457 versus watchful waiting in resected, Stage II (high risk) and Stage III colorectal cancer patients who are ctDNA positive following resection
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A Phase 2, Randomized, Open-label Study of Onvansertib in Combination with FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab Versus FOLFIRI and Bevacizumab or FOLFOX and Bevacizumab for First-line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS or NRAS Mutation
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A Randomized Open-Label Phase 3 Study of XL092 + Atezolizumab vs Regorafenib in Subjects with Metastatic Colorectal Cancer
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A Randomized Phase II Trial Testing the Efficacy of Triplet Versus Doublet Chemotherapy to Achieve Clinical Complete Response in Patients with Locally Advanced Rectal Cancer
Principal Investigator: Val Simianu, MD
Status: Enrolling

HAI Consortium Research Network: Registry of Hepatic Arterial Infusion (HAI)
Principal Investigator: Lauren Wancata, MD
Status: Enrolling

 


A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in Patients with Stage 0-III Colon or Rectal Cancer, Phase III –Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Phase II/III Trial of Neoadjuvant FOLFOX with Selective Use of Combined Modality Chemoradiation versus Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal Cancer Patients Under
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Pilot Protocol Evaluating Safety of the Medtronic Pump and Codman Catheter for the Delivery of Hepatic Arterial Infusion (HAI) Chemotherapy in patients with advanced Colorectal Carcinoma or Cholangiocarcinoma
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

NEOADJUVANT CHEMOTHERAPY, EXCISION AND OBSERVATION FOR EARLY RECTAL CANCER | The NEO Trial.
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

Randomized trial of standard chemotherapy alone or combined with Atezolizumab as adjuvant therapy for patients with Stage III colon cancer and deficient DNA mismatch repair.
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

 

 

Hepatobiliary Cancer (Liver and Biliary Tract)

A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY 4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A Phase 1 Dose-escalation Study of FF-10832 for the Treatment of Advanced Solid Tumors
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A Phase 1b/2 Multicenter, Open-label Study to Evaluate the Safety and Efficacy of TTI-101 as Monotherapy and in Combination in Participants with Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants with unresectable or metastatic cholangiocarcinoma with FGFR2 rearrangement (FIGHT-302)
Principal Investigator: Bruce Lin, MD
Status: Enrolling

A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY EVALUATING ATEZOLIZUMAB AND BEVACIZUMAB, WITH OR WITHOUT TIRAGOLUMAB, IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR METASTATIC HEPATOCELLULAR CARCINOMA
Principal Investigator: Bruce Lin, MD
Status: Enrolling

 


A Phase 3 Double-blinded, Two-arm Study to Evaluate the Safety and Efficacy of Pembrolizumab (MK-3475) versus Placebo as Adjuvant Therapy in Participants with Hepatocellular Carcinoma and Complete Radiological Response after Surgical Resection or Local Ablation (KEYNOTE-937)
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Single Arm Phase Ib/II Multi-Center Study of Nivolumab in Combination with nanoliposomal-Irinotecan, 5-Fluorouracil, and Leucovorin as Second Line Therapy for Patients with Advanced Biliary Tract Cancer
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

A Single-arm Feasibility Study of Gemcitabine, Cisplatin, and Nab-Paclitaxel as Neoadjuvant Therapy for Resectable Oncologically High-Risk Intrahepatic Cholangiocarcinoma
Principal Investigator: Bruce Lin, MD
Status: Closed to Enrollment

Lung Cancer

ATEZOLIZUMAB + SBRT VERSUS SBRT ALONE IN HIGH RISK, EARLY STAGE NSCLC
Principal Investigator: Joseph Rosales, MD
Status: Enrolling

 


A Phase II Double-Blind Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Placebo for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK)
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB (=4 cm)-IIIA Non-Small Cell Lung Cancer (NSCLC).
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Randomized Phase III Study of Maintenance Therapy with Bevacizumab, Pemetrexed, or a Combination of Bevacizumab and Pemetrexed Following Carboplatin, Paclitaxel and Bevacizumab for Advanced Non-Squamous NSCLC
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Pancreatic Cancer

A Phase 1/1b Study of ASP2138 in Participants with Metastatic or Locally Advanced Unresectable Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma or Metastatic Pancreatic Adenocarcinoma Whose Tumors Have Claudin (CLDN) 18.2 Expression
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 1b Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of ATP150/ATP152, VSV-GP154 and Ezabenlimab (BI 754091) in Patients with KRAS G12D/G12V Mutated Pancreatic Ductal Adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 1b/2a Study of Gemcitabine and Nab-paclitaxel in Combination with Avutometinib (VS-6766) and Defactinib in Patients with Previously Untreated Metastatic Adenocarcinoma of the Pancreas
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 2, Open-Label, Randomized Study to Assess the Efficacy and Safety of Zolbetuximab (IMAB362) in Combination with Nab-Paclitaxel and Gemcitabine (Nab P + GEM) as First Line Treatment in Subjects with Claudin 18.2 (CLDN18.2) Positive, Metastatic Pancreatic Adenocarcinoma
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab in Patients with Cancer, Cachexia, and Elevated Concentrations of GDF-15, Followed by an Optional Open Label Treatment Period
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

Alternating neoadjuvant Gemcitabine-Nab-Paclitaxel and nal-IRI with 5-Fluorouracil and folinic acid (Leucovorin) regimens in resectable and borderline resectable pancreatic cancer, A Pilot Study
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

Analysis of Health Outcome of Pancreatic Enzyme Replacement Therapy in Unresectable Pancreatic Cancer
Principal Investigator: Vincent Picozzi, MD
Status: Enrolling

 


A Phase 1a/b Dose-Escalation Study Followed by Expansion Cohorts of NGM120, a GFRAL Antagonist Monoclonal Antibody Blocking GDF15 Signaling, in Subjects With Advanced Solid Tumors and Pancreatic Cancer Using Combination Therapy
Principal Investigator: Vincent Picozzi, MD
Status: Closed to Enrollment

A Phase 3, Randomized, Double-Blind Study of Pamrevlumab or Placebo in combination with Gemcitabine Plus Nab-paclitaxel as Neoadjuvant Treatment in Patients with Locally Advanced, Unresectable Pancreatic Cancer
Principal Investigator: Vincent Picozzi, MD
Status: Closed to Enrollment

PANOVA-3: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 150kHz) concomitant with gemcitabine and nab-paclitaxel for front-line treatment of locally-advanced pancreatic aden
Principal Investigator: Vincent Picozzi, MD
Status: Closed to Enrollment

PRECISION PROMISE PLATFORM TRIAL FOR METASTATIC PANCREATIC CANCER
Principal Investigator: Vincent Picozzi, MD
Status: Closed to Enrollment

VM-BRI repository for early detection of pancreas cancer (VM-BRIDPAN)
Principal Investigator: Margaret Mandelson, PhD
Status: Closed to Enrollment

 

Prostate Cancer

A Phase 2 Open-label Extension Study for Subjects with Prostate Cancer Who Previously Participated in an Enzalutamide Clinical Study
Principal Investigator: John Paul Flores, MD
Status: Closed to Enrollment

NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGH RISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FOR LOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENT THERAPY FOR HIGHER GENOMIC RISK WITH RADIATION (PREDICT-RT*)
Principal Investigator: Huong Pham, MD and John Paul Flores, MD
Status: Enrolling

NRG-GU010: PARALLEL PHASE III RANDOMIZED TRIALS OF GENOMIC-RISK STRATIFIED UNFAVORABLE INTERMEDIATE RISK PROSTATE CANCER: DE-INTENSIFICATION AND INTENSIFICATION CLINICAL TRIAL EVALUATION (GUIDANCE)
Principal Investigator: Huong Pham, MD and John Paul Flores, MD
Status: Enrolling

 


A Multicenter, Randomized, Double-Blind, Placebo-Controlled,Phase III Study of ARN-509 in Men with Non-Metastatic (M0) Castration-Resistant Prostate Cancer
Principal Investigator: Joseph Rosales, MD
Status: Closed to Enrollment

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A PHASE III TRIAL OF SHORT TERM ANDROGEN DEPRIVATION WITH PELVIC LYMPH NODE OR PROSTATE BED ONLY RADIOTHERAPY (SPPORT) IN PROSTATE CANCER PATIENTS WITH A RISING PSA AFTER RADICAL PROSTATECTOMY.
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High Risk Prostate Cancer: A Phase III Randomized Trial
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

CHAARTED: ChemoHormonal Therapy versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

Does the Use of a Post-Operative Pedometer Affect Rate of Return of Bowel Function and Narcotic Use Following Radical Prostatectomy
Principal Investigator: Una Lee, MD
Status: Closed to Enrollment

Phase III IGRT and SBRT vs IGRT and Hypofractionated IMRT for localized intermediate risk prostate cancer
Principal Investigator: Huong Pham, MD
Status: Closed to Enrollment

 

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