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In response to COVID-19, some breast cancer trials have temporarily stopped enrolling new patients. Use the contact information in our trial listings to call or email the research site for information about a trial's status.

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(Last updated: November 29, 2020)

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1

NEAREST SITE: 3 miles
UCSF Comprehensive Cancer Ctr
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03289962

Personalized Cancer Vaccine With or Without Atezolizumab for Advanced Triple Negative Breast Cancer

A Phase 1a/1b Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of RO7198457 as a Single Agent and in Combination With Atezolizumab in Patients With Locally Advanced or Metastatic Tumors Scientific Title

Purpose
To investigate the safety and effects (good and bad) of using a personalized cancer vaccine (RO7198457) alone or with an immunotherapy drug (the PD-LI inhibitor atezolizumab).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. Your cancer must have progressed after receiving standard of care therapy.    Full eligibility criteria
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  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RO7198457, by IV, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The personalized cancer <span class="highlight">vaccine</span> is called RO7198457. </li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-L1 inhibitor atezolizumab (Tecentriq®). </li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) works by blocking the PD-L1 (programmed death-ligand 1) protein and is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03289962' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq-hcp.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug?cdrid=791183' target='_blank'>NCI Drug Dictionary: RO7198457</a> </li></ul>
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2

NEAREST SITE: 53 miles
St. Joseph Heritage Healthcare
Santa Rosa,CA

VISITS: 1 visit every 3 weeks, for 2 years

PHASE: I-II

NCT ID: NCT03761914

Immunotherapy Galinpepimut-S and Pembrolizumab for Advanced Triple Negative Breast Cancer

A Phase 1/2 Study of Galinpepimut-S in Combination With Pembrolizumab (MK 3475) in Patients With Selected Advanced Cancers Scientific Title

Purpose
To assess the safety, effects (good and bad) and best dose of the immunotherapy galinpepimut-S when it is used along with pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR- and HER2-) breast cancer that has not responded to other treatment options.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be given the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GM-CSF, by injection, before Galinpepimut-S</li> <li class="seamTextUnorderedListItem">Galinpepimut-S, by injection, every 3 weeks, for up to 2 years</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, for 2 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Galinpepimut-S is a <span class="highlight">vaccine</span> that targets the protein WT1. </li> <li class="seamTextUnorderedListItem">Higher than normal amounts of this protein are found on the surface of breast and certain other cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It is approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03761914' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sellaslifesciences.com/galinpepimut-s-gps-therapy/' target='_blank'>Trial Sponsor Sellas Lifescience: Galinpepimut-S Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/galinpepimut-s/' target='_blank'>Immuno-Oncology News: Galinpepimut-S</a> </li><li class='seamTextUnorderedListItem'><a href='https://pharmaphorum.com/views-and-analysis/asco-2017-breast-cancer-keytruda/' target='_blank'>Pharmaphorum: ASCO 2017: Breast cancer next target for Keytruda</a> </li></ul>
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3

NEAREST SITE: 336 miles
Ronald Reagan UCLA Medical Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03674827

A Vaccine-Based Immunotherapy for Metastatic Triple Negative Breast Cancer

A Phase 1 Study To Evaluate The Safety, Pharmacokinetics, And Pharmacodynamics Of Escalating Doses And Treatment Intensification Of A Vaccine-based Immunotherapy Regimen-2 (Vbir-2) (Pf-06936308) For Advanced Non-small Cell Lung Cancer And Metastatic Triple-negative Breast Cancer Scientific Title

Purpose
To investigate the safety and effects (good and bad) of increasing doses of a vaccine-based immunotherapy called TPF-06936308.
Who is this for?
People with metastatic (stage IV) triple negative breast cancer (ER-, PR-, HER2-).    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PF-06936308, 4 times every 4 months</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The <span class="highlight">vaccine</span> (TPF-06936308) is designed to make immune cells find and then stop the growth of cancer cells. </li> <li class="seamTextUnorderedListItem">This study is also enrolling people with advanced non-small cell lung cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03674827' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/795350' target='_blank'>NCI Drug Dictionary: Adenoviral cancer vaccine PF-06936308</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/navigating-cancer-care/how-cancer-treated/immunotherapy-and-vaccines/what-are-cancer-vaccines' target='_blank'>Cancer.net: What are Cancer Vaccines?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/what' target='_blank'>Breastcancer.org: What is Immunotherapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/EmergingMetasticBreastCancer.html' target='_blank'>Susan G. Komen: Emerging Areas in Metastatic Breast Cancer</a> </li></ul>
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4

NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA

VISITS: 7 visits over 15 months

PHASE: I

NCT ID: NCT02157051

A Vaccine for Advanced, HER2 Negative Breast Cancer

A Phase I Trial of the Safety and Immunogenicity of a Multiple Antigen Vaccine (STEMVAC) in HER2 Negative Advanced Stage Breast Cancer Patients Scientific Title

Purpose
To study the effects (good and bad) and best dose of an experimental STEMVAC vaccine.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV), HER2 negative (HER2-) breast cancer who have no evidence of disease or metastasis to bone only.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> All participants will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STEMVAC <span class="highlight">vaccine</span>, by injection, every month for 3 months, and at 6 and 12 months</li> <li class="seamTextUnorderedListItem">Follow up visits during months 4 and 15</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Vaccines made from DNA from tumor cells may help the body build an effective immune response to the cancer. </li> <li class="seamTextUnorderedListItem">The STEMVAC is designed to target a protein on breast cancer stem cells that is resistant to chemotherapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02157051' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.historyofvaccines.org/content/articles/cancer-vaccines-and-immunotherapy' target='_blank'>The College of Physicians of Philadelphia: Cancer Vaccines and Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='http://sharedresources.fredhutch.org/profile/disis-nora' target='_blank'>Lead Researcher: Dr. Nora Disis</a> </li><li class='seamTextUnorderedListItem'><a href='https://depts.washington.edu/tumorvac/clinical-trials/breast-cancer/protocol-137' target='_blank'>University of Washington Medicine Cancer Vaccine Institute: Study website</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2018/10/03/mbc-news-4/' target='_blank'>MetastaticTrialTalk.org: Immunotherapy & Metastatic Breast Cancer</a> </li></ul>
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5

NEAREST SITE: 1643 miles
Houston Methodist Cancer Center
Houston,TX

VISITS: 1 visit daily for 2 weeks, then every 3 weeks ongoing

PHASE: II

NCT ID: NCT03004183

Vaccine and Radiation Therapy then Immunotherapy tor Advanced Triple Negative Breast Cancer

Phase II Window of Opportunity Trial of Stereotactic Body Radiation Therapy and In Situ Oncolytic Virus Therapy in Metastatic Triple Negative Breast Cancer and Metastatic Non-Small Cell Lung Cancer Followed by Pembrolizumab (STOMP) Scientific Title

Purpose
To investigate the safety and effects (good and bad) of receiving a vaccine, then SBRT radiation therapy (stereotactic body radiation therapy), then the immunotherapy pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have no other treatment options available.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ADV/HSV-tk, by injection, once</li> <li class="seamTextUnorderedListItem">followed by valacyclovir (anti-viral drug), by mouth, daily, for 2 weeks</li> <li class="seamTextUnorderedListItem">Stereotactic body radiation therapy (SBRT), 5 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">followed by pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The <span class="highlight">vaccine</span> is called ADV/HSV-tk. It is given along with the anti-viral drug valacyclovir. </li> <li class="seamTextUnorderedListItem">The immunotherapy used in this study is pembrolizumab (Keytruda®). It is approved to treat certain types of cancers. </li> <li class="seamTextUnorderedListItem">This study is also enrolling people with advanced non-small cell lung cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03004183' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/aglatimagene-besadenovec' target='_blank'>NCI Drug Dictionary: ADV/HSV-tk</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/valacyclovir-hydrochloride' target='_blank'>NCI Drug Dictionary: Valacyclovir</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/treatment-options/stereotactic-body-radiation-therapy.html' target='_blank'>MD Anderson Cancer Center: SBRT</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nejm.org/doi/full/10.1056/NEJMoa1910549' target='_blank'>New England Journal of Medicine: Pembrolizumab for Early Triple-Negative Breast Cancer</a> </li></ul>
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6

NEAREST SITE: 1754 miles
Cancer Care Specialists of Central Illinois-Swansea
Swansea,IL

VISITS: 1 visit every 3 weeks, for up to 2 years

PHASE: II

NCT ID: NCT04024800

AE37 Vaccine and Immunotherapy Pembrolizumab in Metastatic Triple Negative or ER-Low Breast Cancer

A Phase II Clinical Trial of Pembrolizumab in Combination With the AE37 Peptide Vaccine in Patients With Metastatic Triple-Negative Breast Cancer (NSABP FB-14) Scientific Title

Purpose
To study the safety, best dose and effects (good and bad) of an AE37 peptide vaccine (AE37) when it is given along with the PD-1 inhibitor pembrolizumab (Keytruda®).
Who is this for?
People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or ER-Low (1%-10% ER) who have been treated with at least one line of therapy.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AE37 Peptide <span class="highlight">vaccine</span>, by injection, once every 3 weeks, for 4 months</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda® ), by IV, once every 3 weeks, for up to 2 years</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER-Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER-Low breast cancer.</li> <li class="seamTextUnorderedListItem">The <span class="highlight">vaccine</span> is a type of immunotherapy. It gets the immune cells to see and kill cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor. It gets the immune system to see and kill cancer cells by blocking a checkpoint called PD-1. It is approved to treat metastatic breast tumors that genomic testing has shown are microsatellite instability-high (MSI-H) or have a DNA mismatch repair deficiency (dMMR).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04024800' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/news/pembrolizumab-and-chemotherapy-met-primary-endpoint-in-phase-iii-tnbc-trial' target='_blank'>Targeted Oncology: Pembrolizumab and Chemotherapy Met Primary Endpoint in Phase III TNBC Trial</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ae37-peptide-gm-csf-vaccine' target='_blank'>NCI Drug Dictionary: AE37 peptide</a> </li></ul>
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7

NEAREST SITE: 2108 miles
Ohio State University Medical Center
Columbus,OH

VISITS: 3-4 visits, over 6 months

PHASE: I

NCT ID: NCT01376505

Vaccine Therapy for Metastatic HER2+ Breast Cancer

Phase I Active Immunotherapy Trial With a Combination of Two Chimeric (Trastuzumab-like and Pertuzumab-like) HER-2 B Cell Peptide Vaccine Emulsified in ISA 720 and Nor-MDP Adjuvant in Patients With Advanced Solid Tumors Scientific Title

Purpose
To study the best dose, side effects, and anti-cancer activity of an experimental HER2 vaccine.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 <span class="highlight">vaccine</span>, by injection, 3 times, over 2.5 months</li> </ul> <p class="seamTextPara"> Participants may receive booster vaccination at 6 months.</p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of metastatic cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01376505' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cancer.osu.edu/cancer-specialties/clinical-trials/find-a-clinical-trial/phase-i-active-immunotherapy-trial-with-a' target='_blank'>The Ohio State University Comprehensive Cancer Center: Study website</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2018/10/03/mbc-news-4/' target='_blank'>MetastaticTrialTalk.org: Immunotherapy & Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.gov/cancertopics/factsheet/Therapy/cancer-vaccines' target='_blank'>NCI: Biological Therapies for Cancer</a> </li></ul>
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8

NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC

VISITS: 1 visit

PHASE: NA

NCT ID: NCT03564782

PVSRIPO Vaccine in Stage II, III and IV Triple Negative Breast Cancer

Examining Oncolytic Poliovirus Bioactivity in Tumor Tissue After Intratumoral Administration of PVSRIPO in Women With Triple Negative Breast Cancer Scientific Title

Purpose
To look at the safety, effects (good and bad) and best dose of an experimental immunotherapy called PVSRIPO.
Who is this for?
Women with stage II-III triple negative breast cancer (ER-, PR- and HER2-) that has not responded to other treatment options or who has metastatic (stage IV) TNBC with a local recurrence on the chest wall.    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO, by injection, one time </li> <li class="seamTextUnorderedListItem">Surgery as planned</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVSRIPO is a <span class="highlight">vaccine</span> made out of a modified poliovirus. </li> <li class="seamTextUnorderedListItem">The <span class="highlight">vaccine</span> uses the virus to get the immune system to kill cancer cells. </li> <li class="seamTextUnorderedListItem">You can not get polio from the <span class="highlight">vaccine</span>.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03564782' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/recombinant-oncolytic-poliovirus-pvs-ripo' target='_blank'>Cancer.gov: Recombinant oncolytic poliovirus PVS-RIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.istarioncology.com/our-science/pvs-ripo/' target='_blank'>Sponsor site: PVSRIPO</a> </li><li class='seamTextUnorderedListItem'><a href='http://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e12641' target='_blank'>Journal of Clinical Oncology: Recombinant oncolytic poliovirus combined with checkpoint blockade for breast cancer therapy</a> </li></ul>
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9

NEAREST SITE: 2385 miles
Duke University
Durham,NC

VISITS: Visits every 2 weeks for 6 weeks and/or every 3 weeks for 4 months

PHASE: II

NCT ID: NCT03632941

A Cancer Vaccine and Pembrolizumab for Advanced HER2 Positive Breast Cancer

A Phase II Randomized Study to Evaluate the Immunologic and Antitumor Activity of Concurrent VRP-HER2 Vaccination and Pembrolizumab for Patients With Advanced HER2-overexpressing Breast Cancer Scientific Title

Purpose
To compare the safety and effects (good and bad) of using the investigational tumor vaccine VRP-HER2 alone, to pembrolizumab (Keytruda®) alone, and to both treatments together.
Who is this for?
People with recurrent or advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer.    Full eligibility criteria
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  • What's being studied?
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  • <p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VRP-HER2 (AVX901), by injection, once every 2 weeks, for 6 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, for 4 months </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VRP-HER2 (AVX901), by injection, once every 2 weeks, for 6 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks, for 4 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional procedures: 2 biopsies</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The VRP-HER2 cancer <span class="highlight">vaccine</span> is designed to activate the immune system to go after HER2 positive cancer cells. </li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PDL-1 inhibitor. It is approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03632941' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/her2-ecdtm-virus-like-replicon-particles-vaccine-avx901' target='_blank'>NCI Drug Dictionary: HER2 ECD+TM virus-like replicon particles vaccine AVX901</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5645504/' target='_blank'>Frontiers Endocrinology: Breast Cancer Vaccines: New Insights</a> </li></ul>
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10

NEAREST SITE: 2569 miles
Icahn School of Medicine at Mount Sinai
New York,NY

VISITS: At least 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT03789097

Immunotherapy Vaccine, Radiation and Pembrolizumab for Metastatic Breast Cancer

In Situ Vaccination With Flt3L, Radiation, and Poly-ICLC Combined With Pembrolizumab in Patients With Non-Hodgkin's Lymphoma, Metastatic Breast Cancer, and Head and Neck Squamous Cell Carcinoma Scientific Title

Purpose
To test the safety and effects (good and bad) of an experimental immunotherapy injected into metastases when combined with radiation and pembrolizumab (Keytruda®).
Who is this for?
People with metastatic (stage IV) breast cancer.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, once every 3 weeks</li> <li class="seamTextUnorderedListItem">Flt3L(CDX-301), by injection</li> <li class="seamTextUnorderedListItem">Radiation, 2 small treatments, on day 1 and day 2</li> <li class="seamTextUnorderedListItem">Poly ICLC (Hiltonol), by injection </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapies injected into the metastases are flt3L and poly-ICLC. </li> <li class="seamTextUnorderedListItem">Flt3L is an immune cell growth factor. It gets the body to make more immune cells. </li> <li class="seamTextUnorderedListItem">Poly-ICLC is an immune cell activating factor. It turns on the immune cells that have been brought to the tumor by flt3L. </li> <li class="seamTextUnorderedListItem">Radiation therapy will be targeted at the same metastases as these immunotherapies.</li> <li class="seamTextUnorderedListItem">Keytruda is a type of immunotherapy called a PD-1 inhibitor that is given intravenously (IV). It stimulates the body's immune system to go after cancer cells. It is approved to treat more than 10 types of cancer. Its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03789097' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celldex.com/pipeline/cdx-301.php' target='_blank'>Drug company information page: CDX-301</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/poly-iclc' target='_blank'>NCI Drug Dictionary: poly ICLC</a> </li></ul>
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11

NEAREST SITE: 2693 miles
Dana Farber Cancer Institute
Boston,MA

VISITS: Weekly visits for 5 weeks, then every 3 weeks, ongoing

PHASE: I

NCT ID: NCT03362060

PVX-410 Vaccine & Pembrolizumab for Advanced Triple Negative Breast Cancer That Tests Positive for HLA-A2+

A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC) Scientific Title

Purpose
To study the anti-cancer activity of using the experimental vaccine PVX-410 in combination with the PD-1 inhibitor pembrolizumab (Keytruda®).
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that tests positive for the protein HLA-A2. The researchers will test your tumor for this protein.    Full eligibility criteria
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  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVX-410 <span class="highlight">vaccine</span>, by IV, weekly for 5 weeks </li> <li class="seamTextUnorderedListItem">Followed by 2 booster vaccines 5 weeks after receiving the first <span class="highlight">vaccine</span>, every 4 months </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PVX-410 is an experimental <span class="highlight">vaccine</span> that may help the immune system find and attack cancer cells. </li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy drug called a PD-1 inhibitor that has been approved to treat some cancer types, including breast cancer. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1).</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA-A2</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03362060' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/whats-new-in-immunotherapy-research.html' target='_blank'>Cancer.org: What's New in Cancer Immunotherapy Research?</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncopep.com' target='_blank'>Drug Company Information Page: PVX-410</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li></ul>
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