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(Last updated: July 07, 2020)

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1

NEAREST SITE: 3 miles
University of California at San Francisco (PARENT)
San Francisco,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03734029

Trastuzumab Deruxtican (DS-8201a) for Advanced HER2 Low Expression Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201a, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2-low, Unresectable and/or Metastatic Breast Cancer Subjects [DESTINY-Breast04] Scientific Title

Purpose
To compare the safety and effects (good and bad) of the targeted therapy trastuzumab deruxtican (DS-8201a) to the standard of care.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 low expression 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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (<span class="highlight">DS</span>-<span class="highlight">8201a</span>), by IV, 1 time every 3 weeks, ongoing </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy chosen by your doctor: Capecitabine (Xeloda®), Eribulin (Halaven®), Gemcitabine (Gemzar®), Paclitaxel (Taxol®), or Nab-paclitaxel (Abraxane®)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (<span class="highlight">DS</span>-<span class="highlight">8201a</span>) is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a topoisomerase I inhibitor directly to cancer cells.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03734029' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/anti-her2-adc-ds-8201a' target='_blank'>NCI: anti-HER2 ADC DS-8201a</a> </li></ul>
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2

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT03529110

Trastuzumab Deruxtican (DS-8201a) Versus T-DM1 for Advanced HER2 Positive Breast Cancer

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] Scientific Title

Purpose
To compare the safety and effects (good and bad) of two different HER2-targeted therapies, trastuzumab deruxtican (DS-8201a) and T-DM1 (Kadcyla®).
Who is this for?
People with HER2-positive, advanced (some stage III) or metastatic (stage IV) breast cancer who have already been treated with trastuzumab (Herceptin®) and a taxane-based chemotherapy.    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: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (<span class="highlight">DS</span>-<span class="highlight">8201a</span>), by IV (please contact research site for treatment schedule)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-DM1, by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">DS</span>-<span class="highlight">8201a</span> (trastuzumab deruxtecan) is an experimental HER2-targeted therapy and also an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug DM1 directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is approved to treat HER2-positive metastatic breast cancer that has previously been treated with Herceptin and a taxane chemotherapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03529110' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/.../fda-grants-ds8201-breakthrough-designation-for -her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Kadcyla</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/april-10-2018/potent-anti-her2-agents-on-the-horizon/' target='_blank'>ASCO: Potent Anti-HER2 Agents</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/news/updated-analysis-ongoing-phase-trial-ds-8201-confirms-significant-benefit-her2-breast-cancer-patients-pretreated-ado-trastuzumab-emtansine/' target='_blank'>ADC Review: Trial Update of DS-8201</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/' target='_blank'>ADC Review: What Are Antibody-Drug Conjugates?</a> </li></ul>
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3

NEAREST SITE: 86 miles
Pacific Cancer Care
Monterey,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT03523585

Trastuzumab Deruxtican (DS-8201a) Versus Standard of Care for Advanced HER2 Positive Breast Cancer

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T DM1 [DESTINY-Breast02] Scientific Title

Purpose
To compare the effects (good and bad) of the HER2 targeted therapy trastuzumab deruxtican (DS-8201a) to the standard of care in patients with advanced breast cancer who have already received the HER2 targeted therapy Kadcyla.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer who have already received T-DM1 (Kadcyla®).    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 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (<span class="highlight">DS</span>-<span class="highlight">8201a</span>), by IV (please contact research site for treatment schedule)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times per day</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, 2 times per day</li> <li class="seamTextUnorderedListItem">Lapatinib (Tykerb®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">DS</span>-<span class="highlight">8201a</span> (Trastuzumab deruxtecan) is an experimental HER2-targeted therapy, it is also an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">ADC uses an antibody—the HER2-targeted therapy trastuzumab (Herceptin®)—to deliver the chemotherapy drug directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">T-DM1 (Kadcyla®) is approved to treat HER2-positive metastatic breast cancer that has previously been treated with Herceptin and a taxane chemotherapy.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03523585' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/news/updated-analysis-ongoing-phase-trial-ds-8201-confirms-significant-benefit-her2-breast-cancer-patients-pretreated-ado-trastuzumab-emtansine/' target='_blank'>ADC Review: Trial Update of DS-8201</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/april-10-2018/potent-anti-her2-agents-on-the-horizon/' target='_blank'>ASCO: Potent Anti-HER2 Agents</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/' target='_blank'>ADC Review: What Are Antibody-Drug Conjugates?</a> </li></ul>
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4

NEAREST SITE: 339 miles
UCLA - Medical Center
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT03523572

Trastuzumab Deruxtican (DS-8201a) Plus Immunotherapy for Advanced HER2 Positive or HER2 Low Expression Breast Cancer

A Phase 1b, Multicenter, Two-Part, Open-Label Study of DS-8201a, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer Scientific Title

Purpose
To test the safety and effects (good and bad) of the HER2 targeted therapy trastuzumab deruxtican (DS-8201a) when it is given in combination with an immunotherapy.
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 did not respond to standard therapies    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 receive: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (<span class="highlight">DS</span>-<span class="highlight">8201a</span>), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">DS</span>-<span class="highlight">8201a</span> (Trastuzumab deruxtecan) is a new type of HER2-targeted therapy. </li> <li class="seamTextUnorderedListItem">It is an antibody-drug conjugate (ADC), which means it uses an antibody to deliver a chemotherapy drug directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-</li> <li class="seamTextUnorderedListItem">The immunotherapy being used in this study is the PD-1 inhibitor nivolumab (Opdivo®). By blocking PD-1, it allows your immune system to see and go after cancer cells. </li> <li class="seamTextUnorderedListItem">Opdivo 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/NCT03523572' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/web-exclusives/fda-grants-ds8201-breakthrough-designation-for-her2-breast-cancer' target='_blank'>OncLive: FDA Grants DS-8201 Breakthrough Designation for HER2+ Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/news/updated-analysis-ongoing-phase-trial-ds-8201-confirms-significant-benefit-her2-breast-cancer-patients-pretreated-ado-trastuzumab-emtansine/' target='_blank'>ADC Review: Trial Update of DS-8201</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/april-10-2018/potent-anti-her2-agents-on-the-horizon/' target='_blank'>ASCO: Potent Anti-HER2 Agents</a> </li><li class='seamTextUnorderedListItem'><a href='https://adcreview.com/adc-university/adcs-101/antibody-drug-conjugates-adcs/' target='_blank'>ADC Review: What Are Antibody-Drug Conjugates?</a> </li></ul>
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5

NEAREST SITE: 2521 miles
Fox Chase Cancer Center
Philadelphia,PA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: I

NCT ID: NCT04042701

Trastuzumab Deruxtican (DS-8201a) 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 HER2-targeted therapy trastuzumab deruxtican (DS-8201a) when it is given along with the immunotherapy drug 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) or standard of care therapy.    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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtican (<span class="highlight">DS</span>-<span class="highlight">8201a</span>), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or 2+ and ISH-.</li> <li class="seamTextUnorderedListItem"><span class="highlight">DS</span>-<span class="highlight">8201a</span> (trastuzumab deruxtecan) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. </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.cancer.gov/publications/dictionaries/cancer-drug/def/anti-her2-adc-ds-8201a' target='_blank'>NCI Drug Dictionary: DS8201a</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/cancer-types/breast-cancer-metastatic/types-treatment' target='_blank'>ASCO: Metastatic Breast Cancer, Types of Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2020/tucatinib-trastuzumab-deruxtecan-her2-positive-metastatic-breast-cancer' target='_blank'>NCI Cancer Currents Blog: For Metastatic HER2-Positive Breast Cancer, New Treatments Emerge</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006963.html' target='_blank'>Press Release: HER2 Low Expression</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/conference-coverage/lynn-sage-2019/immunotherapy-for-breast-cancer-whats-new-and-whats-on-the-horizon?p=1' target='_blank'>OncLive: Immunotherapy for Breast Cancer: What's New and What's on the Horizon?</a> </li></ul>
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