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Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

Use the search box and filters to find a trial that’s right for you.


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(Last updated: February 04, 2023)

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1

NEAREST SITE: 3 miles
California Pacific Medical Center-Pacific Campus
San Francisco,CA

VISITS: 1 visit every 3 weeks, for 10 months

PHASE: III

NCT ID: NCT04457596

Two Therapies for People with Stage II-III HER2+ Breast Cancer Who Had Leftover Tumor after Receiving Neoadjuvant Therapy and Surgery

The CompassHER2 Trials (Comprehensive Use of Pathologic Response Assessment to Optimize Therapy in HER2-Positive Breast Cancer) CompassHER2 Residual Disease (RD), a Double-Blinded, Phase III Randomized Trial of T-DM1 Compared With T-DM1 and Tucatinib Scientific Title

Purpose
To study the anti-cancer activity and side-effects of giving the antibody-drug conjugate trastuzumab emtansine/T-DM1 (Kadcyla®) and the anti-HER2 targeted therapy tucatinib (Tukysa®) after surgery.
Who is this for?
People with stage II or stage III HER2-positive breast cancer who received chemotherapy and trastuzumab (or pertuzumab and margetuximab) before surgery. During your surgery, leftover tumor must have been found in your breast or lymph node (residual 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 and receive the following for up to 10 months: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily, </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, twice daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is an anti-HER2-targeted therapy approved for use with specific other therapies. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) 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. It is approved for use in people who had some leftover tumor (residual disease) after receiving neoadjuvant (before surgery) therapies, but 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/NCT04457596' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/residual-disease' target='_blank'>NCI Dictionary of Cancer Terms: Residual Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/cancer-currents-blog/2019/kadcyla-fda-breast-her2-adjuvant' target='_blank'>NCI Cancer Currents Blog: T-DM1 Approval Expanded to Include Some Women with Early-Stage HER2-Positive Breast Cancer</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.breastcancer.org/treatment/druglist/tukysa' target='_blank'>Breastcancer.org: Tukysa (Tucatinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/personalizing-her2-targeted-treatment-strategies-in-early-stage-and-advanced-breast-cancer' target='_blank'>OncLive: Personalizing HER2-Targeted Treatment Strategies in Early-Stage and Advanced Breast Cancer</a> </li></ul>
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2

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

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04539938

Tucatinib and Trastuzumab Deruxtecan for Advanced HER2 Positive Breast Cancer

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination With Trastuzumab Deruxtecan in Subjects With Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer Scientific Title

Purpose
To study the anti-cancer activity and side-effects of giving tucatinib (Tukysa) in combination with fam-trastuzumab deruxtecan-nxki (Enhertu®).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must have already received at least two anti-HER2 targeted therapies 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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Fam-Trastuzumab Deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa) is a type of HER2 targeting therapy called a kinase inhibitor. </li> <li class="seamTextUnorderedListItem">It is able to cross the blood-brain barrier. This means it works against cancer cells that have spread to the brain. </li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> is approved for use in people with metastatic, HER2+ breast cancer when it is taken with for use trastuzumab and capecitabine. Its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Fam-trastuzumab deruxtecan-nxki (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver a chemotherapy drug directly to the cancer cells. </li> <li class="seamTextUnorderedListItem">It is approved for use to treat people with metastatic HER2+ breast cancer who have already received two anti-HER2 therapies but 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/NCT04539938' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/tukysa' target='_blank'>Breastcancer.org: Tukysa</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/view/what-you-need-to-know-about-the-fdas-approval-of-tukysa-for-her2positive-breast-cancer' target='_blank'>Cure Today: What You Need to Know About the FDA's Approval of Tukysa for HER2 Positive Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqjw8fr7brdsarisak0qqr5x8-k8j8h3d3_wahp-jhjvjjtjaqr3dnefidhs2onmte7b9gbmcfmaaoteealw_wcb&gc' target='_blank'>Daiichi-Sankyo AstraZeneca Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/brufsky-spotlights-data-with-trastuzumab-deruxtecan-in-her2-metastatic-breast-cancer' target='_blank'>OncLive: Trastuzumab Deruxtecan in HER2+ Metastatic Breast Cancer</a> </li></ul>
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3

NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA

VISITS: 1 visit every week

PHASE: I-II

NCT ID: NCT05319873

Targeted Therapy for HER2 Positive Stage II-IV Breast Cancer

A Phase 1B Trial Evaluating the Safety of Ribociclib, Tucatinib, and Trastuzumab in Patients With Metastatic, HER2+ Breast Cancer and a Multicenter, Randomized, Open-Label, Phase 2 Study of Preoperative Treatment With Ribociclib,Ttrastuzumab, Tucatinib, and Fulvestrant Versus Docetaxel, Carboplatin,Ttrastuzumab, and Pertuzumab in HR+/HER2+ Breas... Scientific Title

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ribociclib (Kisqali®), trastuzumab (Herceptin®), and tucatinib (Tukysa®) targeted therapies alone or with fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with stage II, stage III, or stage IV (metastatic) HER2 positive (HER2+) or HER2 low breast cancer. If you have stage II or some stage III breast cancer, you must not have received treatment or surgery. If you have advanced (some stage III) or metastatic (stage IV) breast cancer, you must have received at least 1 line of anti-HER2 targeted 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 2 groups based on your type of cancer: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, daily</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor. It blocks two enzymes, CDK 4 and CDK 6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 2+.</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/NCT05319873' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kisqali' target='_blank'>Breastcancer.org: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
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4

NEAREST SITE: 339 miles
UCLA Medical Center / David Geffen School of Medicine
Santa Monica,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: III

NCT ID: NCT05132582

Tucatinib With Trastuzumab and Pertuzumab for Advanced HER2+ Breast Cancer (HER2CLIMB-05)

A Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy for Metastatic HER2+ Breast Cancer (HER2CLIMB-05) Scientific Title

Purpose
To see if tucatinib, trastuzumab and pertuzumab works better than trastuzumab and pertuzumab alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must have already received treatment with trastuzumab, pertuzumab, and taxane as first-line therapy for advanced HER2+ breast cancer with no evidence of disease progression.    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"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®), by IV every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo, by mouth, twice daily </li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®), by IV every 3 weeks</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is being done to see if <span class="highlight">tucatinib</span> works better than placebo when given with other drugs to treat participants with HER2-positive breast cancer. </li> <li class="seamTextUnorderedListItem">A placebo is a pill that looks the same as <span class="highlight">tucatinib</span> but has no medicine in it. </li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is an anti-HER2-targeted therapy approved for use in HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05132582' target='_blank'>ClinicalTrials.gov</a> </li></ul>
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5

NEAREST SITE: 363 miles
Pacific Shores Medical Group
Long Beach,CA

VISITS: 1 visit every 3 weeks, ongoing

PHASE: II

NCT ID: NCT04579380

Tucatinib and Trastuzumab for Advanced HER2 Negative Breast Cancer that Tests Positive for a HER2 Mutation

A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations Scientific Title

Purpose
To study the anti-cancer activity and side effects of giving the anti-HER2 targeted therapies tucatinib (Tukysa®) and trastuzumab (Herceptin®) for HER2 negative breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV), HER2 negative (HER2-) breast cancer whose disease progressed after receiving therapy for advanced disease. Your tumor must also test positive for a HER2/ERBB mutation.    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"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, twice daily, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, once a month, ongoing (only if your disease is hormone positive)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is an anti-HER2-targeted therapy approved for use in HER2 positive breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2 positive breast cancer, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2/ERBB</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04579380' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tukysa.com/?&utm_source=GOOGLE&utm_medium=cpc&utm_campaign=GS_Brand_Fullsite_Alone_PI&utm_content=General_EX&utm_term=tucatinib&gclsrc=ds&gclid=CjwKCAiA9bmABhBbEiwASb35V8_ibwE-Ey-u91KsJCshbmkozNCJ60FlvCmi5bs3npzhPRr6KigNdBoC4VgQAvD_BwE&gclsrc=' target='_blank'>Seagen Drug Information Page: Tukysa® (Tucatinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Trastuzumab' target='_blank'>Wikipedia: Trastuzumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tucatinib-patients-her2-positive-metastatic-breast-cancer' target='_blank'>FDA: FDA Approves Tucatinib for Patients with HER2-Positive Metastatic Breast Cancer</a> </li></ul>
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6

NEAREST SITE: 523 miles
Providence Newberg Medical Center
Newberg,OR

VISITS: 2 visits every 3 weeks

PHASE: I-II

NCT ID: NCT04896320

Tucatinib with Chemotherapy and Trastuzumab for Metastatic HER2-Positive Breast Cancer

A Phase 1/2 Study of Tucatinib With Chemotherapy and Trastuzumab in Patients With Previously Treated, Advanced Her-2-Neu Overexpressing Breast Cancer. Scientific Title

Purpose
To study the safety, best dose, and effects (good and bad) of tucatinib (Tukysa®) and trastuzumab (Herceptin®) with two different chemotherapies.
Who is this for?
People with metastatic (stage IV) HER2-positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®) and capecitabine (Xeloda®). You must not have received treatment with both gemcitabine (Gemzar®) and vinorelbine (Navelbine®).    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 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®), by IV, weekly, 2 weeks on, 1 week off</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Vinorelbine (Navelbine®), by IV, weekly, 2 weeks on, 1 week off</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is a type of HER2 targeted therapy called a kinase inhibitor.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is approved for use in people with metastatic HER2+ breast cancer when taken with trastuzumab and capecitabine. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Gemcitabine (Gemzar®) and vinorelbine (Navelbine®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a targeted therapy routinely used for 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/NCT04896320' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tukysa.com/' target='_blank'>Seagen Drug Information Page: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/druglist/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/druglist/gemzar' target='_blank'>Breastcancer.org: Gemcitabine (Gemzar®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/druglist/navelbine' target='_blank'>Breastcancer.org: Vinorelbine (Navelbine®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/druglist/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li></ul>
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7

NEAREST SITE: 679 miles
Swedish Cancer Institute
Issaquah,WA

VISITS: 1 visit every 1-2 weeks

PHASE: II

NCT ID: NCT05458674

Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer

A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab (Herceptin®) anti-HER2 targeted therapy, tucatinib (Tukysa®) tyrosine kinase inhibitor, and eribulin (Halaven®) chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®) and chemotherapy for advanced/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 receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug approved to treat 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/NCT05458674' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>
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8

NEAREST SITE: 941 miles
University of Colorado Cancer Center
Aurora,CO

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05230810

Targeted Therapy for Metastatic HER2+ Breast Cancer with a PIK3CA Mutation

This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer. Scientific Title

Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of alpelisib (Piqray®) PI3K inhibitor and tucatinib (Tukysa) anti-HER2 targeted therapy with or without fulvestrant (Faslodex®) hormone therapy.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have received 2+ anti-HER2 targeted therapies.    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">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection (for people with HR positive breast cancer)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors. You will only receive fulvestrant (Faslodex®) if you have HR+ (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women with HR+ breast cancer will also be given a drug that will put women in temporary menopause.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05230810' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>
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9

NEAREST SITE: 1454 miles
Research Site
Fort Worth,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04538742

Trastuzumab Deruxtecan Alone and with Other Anti-Cancer Therapies for Metastatic HER2 Positive Breast Cancer

A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07) Scientific Title

Purpose
To study the safety, side effects, and anti-cancer activity of giving the antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu®) alone and with other anti-cancer therapies.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must have not received prior 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 randomly assigned to 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) by IV, ongoing</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®), by IV, ongoing</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®), by IV, ongoing</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab Deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It targets HER2 to deliver chemotherapy directly to cancer cells. It is approved to treat some metastatic HER2+ breast cancer, but its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor. It works by stimulating the body's immune system to go after cancer cells. It is approved to treat some cancers, but its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2-targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is a HER2-targeted therapy. Research indicates it works against HER2+ breast cancer cells that have spread to the brain. It is already approved to treat some metastatic breast cancer, but its use in this trial is experimental.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04538742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/enhertu' target='_blank'>Breastcancer.org: Enhertu® (Trastuzumab Deruxtecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/news/march-2021/updated-destiny-breast01-results-show-trastuzumab-deruxtecan-nxki-delivers-durable-responses/' target='_blank'>The ASCO Post: Miami Breast Cancer Conference, Updated DESTINY-Breast01 Results Show Trastuzumab Deruxtecan-nxki Delivers Durable Responses</a> </li></ul>
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10

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

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05323955

Targeted Therapy for Metastatic HER2+ Breast Cancer with Brain Metastases

Secondary BRain Metastases Prevention After Isolated Intracranial Progression on Trastuzumab/Pertuzumab or T-DM1 in Patients With aDvanced Human Epidermal Growth Factor Receptor 2+ brEast Cancer With the Addition of Tucatinib Scientific Title

Purpose
To study the safety, effects (good and bad), and anti-cancer activity of
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain (brain metastasis) who have not received whole brain radiation 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®)</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1)</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®)</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®)</li></ul>
  • <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1) is an antibody drug conjugate (ADC).</li> <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 (Kadcyla®, T-DM1)'s antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called emtansine.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are anti-HER2 targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem"><span class="highlight">Tucatinib</span> (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li></ul>
  • <ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05323955' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab emtansine (Kadcyla®, T-DM1)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancer.org: Pertuzumab (Perjeta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa®)</a> </li></ul>
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