Breast Cancer Clinical Trial

My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors

Summary

This multicenter, non-randomized, open-label study will evaluate the efficacy and safety of six treatment regimens in participants with advanced solid tumors for whom therapies that will convey clinical benefit are not available and/or are not suitable options per the treating physician's judgment.

View Eligibility Criteria

Eligibility Criteria

General Inclusion Criteria:

Life expectancy greater than or equal to (≥) 12 weeks
Histologically documented metastatic cancer (solid tumors, not including hematologic malignancies)
Participants who have received standard first-line therapy for metastatic cancer (except for the tumors for which no first-line therapy exists) and in whom a trial of targeted therapy is considered the best available treatment option. Eligible participants should not have available therapies that will convey clinical benefit and/or are not suitable options per the treating physician's judgment
No previous treatment with the specific assigned study drug or any other drug sharing the same target
Measurable disease by RECIST v1.1
Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 (For patients enrolling in the atezolizumab arm, ECOG score must be documented within 7 days prior to first treatment and confirmation of ECOG PS must be entered into the interactive web response system [IWRS] prior to initiation of treatment)
Adequate hematologic, renal, and liver function as defined by the protocol
If applicable, use of contraception methods or abstinence as defined by the protocol

Study-Drug Specific Inclusion Criteria:

Trastuzumab plus Pertuzumab

Molecular testing results from clinical laboratory improvement amendments (CLIA)-certified laboratories (using tissue and/or blood) demonstrating HER2 overexpression or amplification. Participants must have one of the following tumor types: biliary cancer, salivary cancer, or bladder cancer

a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)

Left ventricular ejection fraction (LVEF) greater than (>) 50 percent (%) or above the lower limit of the institutional normal range, whichever is lower
Availability of an archival or new pre-treatment tissue sample is required if molecular testing was not performed by Foundation Medicine. Any available tumor tissue sample can be submitted. The tissue sample must be submitted within 4 weeks after enrollment

Erlotinib

Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating EGFR-activating mutations

Vemurafenib plus Cobimetinib

Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating BRAF V600 mutations a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)

Vismodegib

Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating hedgehog pathway relevant mutation (activating mutation of smoothened [SMO] or loss-of-function mutation of protein patched homolog-1 [PTCH-1])

a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)

All non-hematological adverse events related to any prior chemotherapy, surgery, or radiotherapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade less than or equal to (≤) 2 prior to starting therapy

Alectinib

Molecular testing results from CLIA-certified laboratories (using tissue and/or blood) demonstrating anaplastic lymphoma kinase (ALK) gene rearrangements, ALK mutations, ALK copy number gain or (for melanoma only) increased ALK expression or presence of ALK-alternative transcription initiation transcript (ALKATI) a) For participants screened using a blood assay: obtain tissue-based testing result confirming study eligibility (within first 4 weeks after enrollment)

Atezolizumab

Molecular testing results from CLIA-certified laboratories (using tissue) demonstrating elevated tissue tumor mutational burden (tTMB ≥10 mutations/ Megabase [Mb])
For patients where molecular testing was not performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is mandatory. For patients where molecular testing was performed using Foundation Medicine, submission of an archival or new pretreatment tissue sample is required, if available. The tissue sample must be submitted within 4 weeks after enrollment

General Exclusion Criteria:

Participants with hematologic malignancies
Concurrent administration of any other anti-cancer therapy (except male participants with prostate cancer receiving androgen blockade): Bisphosphonates and denosumab are allowed; Most recent anti-cancer therapy ≤28 days and have not recovered from the side effects, excluding alopecia; Radiation therapy within ≤14 days
Active or untreated brain metastases
History of carcinomatous meningitis
Uncontrolled concurrent malignancy (early stage is allowed if not requiring active therapy or intervention)
Pregnant or breastfeeding women, or intending to become pregnant during the study
Any significant cardiovascular events within 6 months prior to study entry
Pulmonary embolism within 30 days prior to study entry
History or presence of clinically significant ventricular or atrial dysrhythmia >Grade 2 per NCI CTCAE v4.0
Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol

Study-Drug Specific Exclusion Criteria:

Trastuzumab plus Pertuzumab

Previous treatment with any HER2-targeted therapy

Erlotinib

Non-small cell lung cancer (NSCLC) or pancreatic cancer identified by exon 19 deletions or exon 21 L858R substitution mutations
EGFR amplifications in the absence of EGFR-activating mutations
Cancers with exon 20 mutations
Previous treatment with erlotinib or any other EGFR inhibitor
Inability to swallow pills
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of erlotinib

Vemurafenib plus Cobimetinib

Malignant melanoma, papillary thyroid cancer, colorectal cancer, or hematologic malignancy including multiple myeloma
LVEF below institutional lower level of normal (LLN) or below 50%, whichever is lower
History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, retinal vein occlusion (RVO), or neovascular macular degeneration
Presence of any of the following conditions, which are risk factors for RVO: Uncontrolled glaucoma with intraocular pressure >21 millimetres of mercury (mm Hg); Serum cholesterol ≥Grade 2; Hypertriglyceridemia ≥Grade 2; Hyperglycemia (fasting) ≥Grade 2; Grade ≥2 uncontrolled hypertension (participants with a history of hypertension controlled with anti-hypertensive medication to Grade Prior or concurrent malignancy with known RAS mutation
Previous treatment with vemurafenib or any other BRAF inhibitor (prior sorafenib is allowed)
Previous treatment with cobimetinib or any other mitogen-activated protein/extracellular signal-regulated kinase (MEK) inhibitor
Prior treatment with a RAF inhibitor
Inability to swallow pills
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of vemurafenib
History of congenital long QT syndrome or mean (average of triplicate measurements) corrected QT (QTc) measured using Fridericia's method ≥450 millisecond (ms) at baseline or uncorrectable abnormalities in serum electrolytes (sodium, potassium, calcium, magnesium, phosphorus)

Vismodegib

Basal cell carcinoma of the skin, medulloblastoma, small-cell lung cancer, or hematologic malignancies
Previous treatment with vismodegib or any other hedgehog pathway inhibitor
Inability to swallow pills
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of vismodegib

Alectinib

ALK-positive NSCLC, neuroblastoma, and childhood tumors
Previous treatment with alectinib or any other ALK inhibitor
Participants with symptomatic bradycardia
Administration of strong/potent cytochrome P3A4 (CYP3A4) inhibitors or inducers within 14 days prior to the first dose of study treatment and while on treatment with alectinib
Inability to swallow pills
Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude absorption of alectinib

Atezolizumab

History of leptomeningeal disease
Uncontrolled tumor pain
Asymptomatic metastatic lesions that would likely cause functional deficits or intractable pain with further growth (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Patients with indwelling catheters are allowed
Uncontrolled or symptomatic hypercalcemia
Previous treatment with atezolizumab or another programmed death-1 (PD-1)/PD-L1 inhibitor
History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
Known hypersensitivity to biopharmaceutical agents produced in Chinese hamster ovary cells
Known allergy or hypersensitivity to any component of the atezolizumab formulation
Active or history of autoimmune disease or immune deficiency
Prior allogeneic stem cell or solid organ transplantation
History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
Positive human immunodeficiency virus (HIV) test, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection or active tuberculosis
Severe infection within 4 weeks prior to initiation of study treatment
Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina
Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study or within 5 months after the final dose of atezolizumab
History of other malignancy within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death, such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer
Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk from treatment complications
Prior treatment with cluster of differentiation 137 (CD137) agonists or immune checkpoint blockade therapies
Treatment with systemic immunostimulatory agents within 4 weeks or five half-lives of the drug (whichever is longer) prior to randomization
Treatment with systemic immunosuppressive medication within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

676

Study ID:

NCT02091141

Recruitment Status:

Active, not recruiting

Sponsor:

Genentech, Inc.

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There are 60 Locations for this study

See Locations Near You

Western Regional Medical Center at Cancer Treatment Centers of America
Goodyear Arizona, 85338, United States
Mayo Clinic Arizona
Phoenix Arizona, 85259, United States
Highlands Oncology Group
Springdale Arkansas, 72762, United States
Science 37, Inc
Culver City California, 90230, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Moores UCSD Cancer Center; Dept Clinical Trials Office
La Jolla California, 92093, United States
Eisenhower Medical Center
Rancho Mirage California, 92270, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco California, 94118, United States
Stanford Comprehensive Cancer Center
Stanford California, 94305, United States
Kaiser Permanente - Vallejo
Vallejo California, 94589, United States
University of Colorado
Aurora Colorado, 80045, United States
SCRI Florida Cancer Specialists South
Fort Myers Florida, 33916, United States
Mayo Clinic
Jacksonville Florida, 32224, United States
Florida Hospital Cancer Inst; Memorial System Onc Clin Rsch
Orlando Florida, 32804, United States
Florida Cancer Specialist, North Region
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists, Research Department
West Palm Beach Florida, 33401, United States
University Cancer & Blood Center, LLC; Research
Athens Georgia, 30607, United States
Northeast Georgia Medical Center; Oncology Research Dept-5C
Gainesville Georgia, 30501, United States
Southeastern Regional Medical Center, Inc.
Newnan Georgia, 30265, United States
Northwestern University; Robert H. Lurie Comp Can Ctr; Northwestern Medicine Development Inst
Chicago Illinois, 60611, United States
University Of Chicago Medical Center; Section Of Hematology/Oncology
Chicago Illinois, 60637, United States
Midwestern Regional Med Center
Zion Illinois, 60099, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21287, United States
Mayo Foundation
Rochester Minnesota, 55905, United States
Research Medical Center - Antibiotic Research Associates, Inc.
Kansas City Missouri, 64132, United States
Memorial Sloan Kettering - Monmouth
Middletown New Jersey, 07748, United States
University of New Mexico Comprehensive Cancer Center
Albuquerque New Mexico, 87102, United States
University of New Mexico Comprehensive Cancer Center - Albuquerque Cedar Street; Drug Shipment
Albuquerque New Mexico, 87106, United States
University of New Mexico Comprehensive Cancer Center - Albuquerque Lang NE; Drug Shipment
Albuquerque New Mexico, 87109, United States
University of New Mexico
Albuquerque New Mexico, 87131, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Memorial Sloan Kettering Cancer Center at Westchester
Harrison New York, 10604, United States
Weill Cornell Univ Medical Ctr; Breast Cancer Center
New York New York, 10021, United States
Herbert Irving Comprehensive Cancer Center; Herbert Irving Pavillion
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Univ No Carolina School of Med; Physicians Office Bldg
Chapel Hill North Carolina, 27599, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
Wake Forest Univ Health Svcs; Internal Medicine
Winston-Salem North Carolina, 27157, United States
Sanford Roger Maris Cancer Center
Fargo North Dakota, 58102, United States
Oncology Hematology Care Inc
Cincinnati Ohio, 45242, United States
Cleveland Clinic
Cleveland Ohio, 44106, United States
University Hospitals of Cleveland
Cleveland Ohio, 44106, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Abramson Cancer Center
Philadelphia Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Eastern Regional Medical Ctr
Philadelphia Pennsylvania, 19124, United States
UPMC - Hillman Cancer Center
Pittsburgh Pennsylvania, 15232, United States
Abington Mem Hosp-Abington; Rose. Can Ctr,Gyn Onc Ins
Willow Grove Pennsylvania, 19090, United States
Sanford Cancer Cnt Onco Clinic
Sioux Falls South Dakota, 57104, United States
SCRI Tennessee Oncology Chattanooga
Chattanooga Tennessee, 37404, United States
West Clinic
Germantown Tennessee, 38138, United States
Tennessee Cancer Specialists
Knoxville Tennessee, 37920, United States
Tennessee Onc., PLLC - SCRI
Nashville Tennessee, 37203, United States
Vanderbilt Ingram Cancer Clinic
Nashville Tennessee, 37232, United States
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth Texas, 76104, United States
MD Anderson
Houston Texas, 77030, United States
Virginia Cancer Institute
Richmond Virginia, 23229, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

676

Study ID:

NCT02091141

Recruitment Status:

Active, not recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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