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(Last updated: October 14, 2021)

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1

NEAREST SITE: 2 miles
San Francisco General Hospital
San Francisco,CA

VISITS: 1 visit every 3 weeks

PHASE: III

NCT ID: NCT03975647

Trastuzumab Emtansine/T-DM1 Alone or with Tucatinib for Advanced, HER2+ Breast Cancer

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer Scientific Title

Purpose
To compare the anti-cancer activity and side effects of giving of the anti-HER2 targeted therapy tucatinib (Tukysa®) and trastuzumab emtansine/T-DM1 (Kadcyla®) together to just giving trastuzumab emtansine/T-DM1 (Kadcyla®).
Who is this for?
People with locally advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have previously been treated with a taxane and trastuzumab (Herceptin®).    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 randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is an anti-HER2-targeted therapy approved for use with certain other therapies. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -— to deliver the chemotherapy DM1 directly to the cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03975647' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tukysahcp.com' target='_blank'>Seagen Information Page: Tukysa (Tucatinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Kadcyla® (Trastuzumab emtansine/T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/tucatinib-shows-promise-in-patients-with-breast-cancer-and-brain-metastases' target='_blank'>OncLive: Tucatinib Shows Promise in Patients With Breast Cancer and Brain Metastases</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/news/tucatinib-shows-promise-phase-i-study-her2-positive-breast-cancer' target='_blank'>CancerNetwork:Tucatinib Shows Promise in Phase I Study of HER2-Positive Breast Cancer</a> </li></ul>
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2

NEAREST SITE: 3 miles
University of California San Francisco Medical Center
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04042701

Trastuzumab Deruxtecan and Pembrolizumab for Advanced HER2 Positive and HER2 Low Expression Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, In Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC) Scientific Title

Purpose
To find the best dose and to study the safety, effects (good and bad), and anti-tumor activity of the targeted therapy fam-trastuzumab deruxtecan-nxki (Enhertu®) when it is given in combination with the immunotherapy pembrolizumab (Keytruda®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low expression breast cancer whose cancer progressed after receiving trastuzumab emtansine/T-DM1 (Kadcyla®) or standard of care 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">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy directly to the cancer cells. It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking PD-1 allows the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of solid tumors.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04042701' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2-positive-breast-cancer' target='_blank'>FDA: FDA Approves Fam-Trastuzumab Deruxtecan-nxki</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/fam-trastuzumab-deruxtecan' target='_blank'>NCI Drug Dictionary: Fam-Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/february-2020/trastuzumab-deruxtecan-in-her2-low-expressing-previously-treated-advanced-breast-cancer/' target='_blank'>ASCO Post: Trastuzumab Deruxtecan in HER2–Low-Expressing, Previously Treated Advanced Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Pembrolizumab' target='_blank'>Wikipedia: Pembrolizumab</a> </li></ul>
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3

NEAREST SITE: 339 miles
UCLA Hematology/Oncology Parkside
Santa Monica,CA

VISITS: 1 visit every 2 weeks, ongoing

PHASE: II

NCT ID: NCT04224272

Targeted Therapy ZW25, Palbociclib, & Fulvestrant for People with Advanced HER2+, HR+ Breast Cancer

Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant Scientific Title

Purpose
To assess the safety and effects (good and bad) of the experimental HER2-targeted therapy ZW25 when it is given with palbociclib (Ibrance®) and fulvestrant (Faslodex®).
Who is this for?
People who have advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), hormone positive (ER+ and/or PR+) breast cancer; have previously been treated with trastuzumab (Herceptin®), pertuzumab (Perjeta®), or Trastuzumab emtansine/T-DM1 (Kadcyla®); and not have been treated with a CDK4/6 inhibitor.    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">ZW25, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily,</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, twice a month for the first month, then once a month, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ZW25 is a new type of HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK4/6 inhibitor. </li> <li class="seamTextUnorderedListItem">It is approved for use along with a hormone therapy to treat metastatic hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer.</li> <li class="seamTextUnorderedListItem">Faslodex is a hormone therapy approved to treat postmenopausal people with <span class="highlight">advanced</span> breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04224272' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-her2-bi-specific-monoclonal-antibody-zw25' target='_blank'>NCI Drug Dictionary: ZW25</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/News/59508' target='_blank'>ASCO: Investigational Anti-HER2 Therapy in HER2-Expressing Solid Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/herceptin' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://dailynews.ascopubs.org/do/10.1200/ADN.19.190160/full/' target='_blank'>ASCO: The Role of CDK4 Inhibitors in Triple-Positive Breast Cancers</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2017/fda-fulvestrant-breast-cancer' target='_blank'>NCI Cancer Currents Blog: FDA Expands Approval of Fulvestrant for Advanced Breast Cancer</a> </li></ul>
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4

NEAREST SITE: 341 miles
Cedar-Sinai
Beverly Hills,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT03530696

Antibody-Drug Conjugate T-DM1 and Palbociclib for Advanced HER2 Positive Breast Cancer

A Randomized Phase II Study to Evaluate Efficacy of T-DM1 With or Without Palbociclib in the Treatment of Patients With Metastatic HER2 Positive Breast Cancer Scientific Title

Purpose
To compare the side effects and effectiveness of the combination of trastuzumab emtansine/T-DM1 (Kadcyla®) and palbociclib (Ibrance®) to trastuzumab emtansine/T-DM1 (Kadcyla®) alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2-positive 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 be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 2 weeks on, 1 week off </li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, once every 3 weeks </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -- to directly deliver the chemotherapy DM1 to the cancer cells.</li> <li class="seamTextUnorderedListItem">It is approved for patients with previously treated HER2-positive metastatic breast cancer. </li> <li class="seamTextUnorderedListItem">Ibrance® is a CDK4/6 inhibitor approved to treat metastatic breast cancer when given along with hormone therapy--either letrozole (Femara®) or fulvestrant (Faslodex®).</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03530696' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://cslide.ctimeetingtech.com/library/esmo/browse/search/258K#2F3503b' target='_blank'>ESMO: Palbociclib in combination with T-DM1 for metastatic HER2+ breast cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/RecommendedTreatmentsforMetastaticBreastCancer.html' target='_blank'>Susan G. Komen: Trastuzumab emtansine/T-DM1 (Kadcyla®)</a> </li></ul>
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5

NEAREST SITE: 390 miles
Emad Ibrahim, Md, Inc
Redlands,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT04740918

Antibody-Drug Conjugate T-DM1 and Immunotherapy for Advanced HER2+, PD-L1+ Breast Cancer

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Study of the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo in Patients With HER2-Positive and PD-L1-Positive Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab- (+/- Pertuzumab) and Taxane-Based Therapy (... Scientific Title

Purpose
To study the anti-cancer activity, safety, and side effects of giving trastuzumab emtansine/T-DM1 (Kadcyla®) with atezolizumab (Tecentriq®) to giving trastuzumab emtansine alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), PD-L1 positive breast cancer. You must not have already received more than two chemotherapies for metastatic disease.    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 randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Placebo for atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®) is an antibody-drug conjugate (ADC). It uses an antibody — the HER2-targeted therapy trastuzumab — to deliver the chemotherapy DM1 directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04740918' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: T-DM1 (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/atezolizumab.aspx' target='_blank'>Chemocare: Atezolizumab</a> </li></ul>
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6

NEAREST SITE: 538 miles
Providence
Portland,OR

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04246671

Experimental Vaccine for Advanced HER2 Positive Breast Cancer

Phase 1/2 Expansion Cohorts Trial of Intravenous Administration of TAEK-VAC-HerBy Vaccine Alone and in Combination With HER2- and PD-1/PD-L1 Antibodies in Patients With Advanced HER2-expressing Cancer Scientific Title

Purpose
To study the safety, anti-cancer activity and effects (good and bad) of giving an experimental vaccine called TAEK-VAC-HerBy alone or in combination with other therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have already received at least one therapy for advanced disease.    Full eligibility criteria
Contact research site
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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">Vaccine (TAEK-VAC-HerBy), by IV, every 3 weeks, 3 times</li> </ul> <p class="seamTextPara"> With or without one or more of the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li> <li class="seamTextUnorderedListItem">T-DM1 (<span class="highlight">Kadcyla</span>®), by IV</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li> <li class="seamTextUnorderedListItem">a PD-1/PD-L1 inhibitor, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TAEK-VAC-HerBy is the experimental vaccine used in this trial. Researchers believe it may stimulate the immune system to go after HER2 positive cancer cells.</li> <li class="seamTextUnorderedListItem">Other therapies you may receive during this trial include: trastuzumab (Herceptin®), T-DM1 (<span class="highlight">Kadcyla</span>®), pertuzumab (Perjeta®), and a PD-1/PD-L1 inhibitor.</li> <li class="seamTextUnorderedListItem">Trastuzumab and pertuzumab are anti-HER2 targeted therapies commonly used to treat <span class="highlight">advanced</span> HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">T-DM1 is an antibody-drug conjugate (ADC). It uses the HER2-targeted therapy trastuzumab to deliver the chemotherapy DM1 directly to cancer cells.</li> <li class="seamTextUnorderedListItem">PD-1/PD-L1 inhibitors are a type of immunotherapy. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of <span class="highlight">advanced</span> cancers.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04246671' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/taek-vac-herby-vaccine?redirect=true' target='_blank'>NCI Drug Dictionary: TAEK-VAC-HerBy Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/inside-clinical-trials/breast-cancer-treatment-vaccines/' target='_blank'>Metastatic Trial Talk: Breast Cancer Treatment Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-positive-breast-cancer-research-update/' target='_blank'>Metastatic Trial Talk: HER2 Positive Metastatic Breast Cancer Research Update</a> </li></ul>
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7

NEAREST SITE: 1482 miles
10 sites incl TX, WA, VA, and NV
Dallas,TX

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I-II

NCT ID: NCT03379428

Ibrutinib and Herceptin in HER2+ Advanced Breast Cancer

Phase I/II Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer Scientific Title

Purpose
To investigate the safety and effects (good and bad) of using an experimental therapy along with trastuzumab (Herceptin®).
Who is this for?
Women with metastatic (stage IV) breast cancer that is HER2 positive. Your tumor must have progressed while you were receiving T-DM1 (kadcyla) anti-HER2 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">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Ibrutinib (Imbruvica®), by mouth, daily</li></ul>
  • <p class="seamTextPara"> Ibrutinib (Imbruvica) is the experimental targeted therapy being used in this study. It is currently approved for treating certain types of blood cancers. </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Herceptin is a targeted therapy used to treat HER2-positive breast cancer.</li> </ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03379428' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/inside-oncology/cll-therapeutic-management/cll-the-biologics-of-ibrutinib-therapy' target='_blank'>OncLive: Ibrutinib</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org Targeted Therapy</a> </li></ul>
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8

NEAREST SITE: 1578 miles
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park,MN

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04351230

Trastuzumab Emtansine/T-DM1 With or Without Abemaciclib for Advanced HER2 Positive Breast Cancer

Phase II Trial of Abemaciclib and T-DM1 in Women and Men With HER2-positive Advanced or Metastatic Breast Cancer Who Progressed on Treatment With a Taxane, Trastuzumab and Pertuzumab Scientific Title

Purpose
To study the anti-cancer activity of giving the antibody-drug conjugate trastuzumab emtansine/T-DM1 (Kadcyla®) alone or in combination with the CDK 4/6 inhibitor abemaciclib (Verzenio®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer.    Full eligibility criteria
Contact research site
Close

Contact Research Sites

  • What's involved?
  • What's being studied?
  • How can I learn more?
  • <p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®) is an ADC. It combines the chemotherapy DM1 with the HER2 targeted therapy trastuzumab. </li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a CDK 4/6 inhibitor that is commonly used to treat metastatic, hormone positive (ER+ and/or PR+) breast cancer. Its use in this trial 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/NCT04351230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.kadcyla.com/patient/metastatic-breast-cancer.html' target='_blank'>Genentech Drug Information Page: Kadcyla® (Trastuzumab Emtansine)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine/T-DM1 (Kadcyla®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/november-10-2019/abemaciclib-benefits-patients-with-her2-positive-breast-cancer-in-monarcher-trial/' target='_blank'>ASCO Post: Abemaciclib Benefits Patients With HER2-Positive Breast Cancer</a> </li></ul>
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9

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: 1 visit every week to 2 weeks, ongoing

PHASE: II

NCT ID: NCT03202316

Atezolizumab, Cobimetinib & Eribulin for Metastatic Inflammatory Breast Cancer

A Phase II Study of Triple Combination of Atezolizumab + Cobimetinib + Eribulin (ACE) in Patients With Chemotherapy Resistant Metastatic Inflammatory Breast Cancer Scientific Title

Purpose
To determine the safety and effects (good and bad) of a combination therapy including chemotherapy, immunotherapy, and targeted therapies.
Who is this for?
Women with advanced (some stage III) or metastatic (stage IV) inflammatory breast cancer. If your cancer is HER2 positive (HER2+), you must have received at least two anti-HER2 therapies, including pertuzumab (Perjeta®) and trastuzumab emtansine/T-DM1 (Kadcyla®).    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> <p class="seamTextPara"> <i class="seamTextEmphasis">First 2 weeks</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, once</li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, 8 times over 3.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Followed by</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®), mouth, weekly (3 weeks on, 1 week off), ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor. </li> <li class="seamTextUnorderedListItem">FDA has approved Tecentriq® to treat certain types of bladder and lung cancer. </li> <li class="seamTextUnorderedListItem">Cobimetinib (Cotellic®) is a new targeted therapy called an MEK inhibitor. It is approved to treat certain types of melanoma. </li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy approved for treating metastatic breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03202316' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tecentriq.com' target='_blank'>Genentech Information Page: Tecentriq</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Cobimetinib' target='_blank'>Wikipedia: Cobimetinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cotellic.com' target='_blank'>Genentech Information Page: Cotellic</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.halaven.com/metastatic-breast-cancer' target='_blank'>Drug Company Information Page: Halaven</a> </li></ul>
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10

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT04296942

Vaccine, Entinostat, Adotrastuzumab Emtansine and Bintrafusp Alfa for Metastatic HER2 Positive and Hormone Negative Breast Cancer

A Phase 1b Trial of Sequential Combinations of BN-Brachyury, Entinostat, Ado-trastuzuamb Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) Scientific Title

Purpose
To study the safety, anti-cancer activity and other effects (good and bad) of giving a combination of immunotherapies alone, with an antibody-drug conjugate, or with an antibody-drug conjugate and a targeted therapy.
Who is this for?
People with metastatic (stage IV), hormone negative (ER- and PR-) breast cancer who have already received at least one therapy for metastatic disease.    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 assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MVA-BN-Brachyury, by injection, every 3 weeks for 6 months, then every 3 months, ongoing </li> <li class="seamTextUnorderedListItem">FPV-BN-Brachyury, by injection, every 3 weeks, ongoing </li> <li class="seamTextUnorderedListItem">M7824 (bintrafusp alfa), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine/T-DM1 (<span class="highlight">Kadcyla</span>®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Entinostat, by mouth, once a week, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The Brachyury injections are vaccines that researchers believe will help your immune system go after cancer cells. </li> <li class="seamTextUnorderedListItem">Bintrafusp alfa (M7824) is an investigational immunotherapy. It is designed to get the immune system to go after cancer cells by blocking the proteins PD-L1 and TGF-beta.</li> <li class="seamTextUnorderedListItem">Ado-trastuzumab emtansine (<span class="highlight">Kadcyla</span>®) is an antibody-drug conjugate (ADC). It uses trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells. It is approved to treat HER2 positive metastatic breast cancer, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Entinostat is an investigational targeted therapy called an HDAC inhibitor.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04296942' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bavarian-nordic.com/what-we-do/cancer-immunotherapy/chordoma.aspx' target='_blank'>Bavarian Nordic Drug Information Page: BN-BRACHYURY</a> </li><li class='seamTextUnorderedListItem'><a href='https://immuno-oncologynews.com/io-m7824/?cn-reloaded=1' target='_blank'>Immunotherapy-Oncology News: M7824(Bintrafusp Alfa)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/ado-trastuzumab-emtansine' target='_blank'>NCI Drug Dictionary: Ado-Trastuzumab Emtansine</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.syndax.com/pipeline/entinostat/' target='_blank'>Syndax Drug Information Page: Entinostat</a> </li></ul>
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