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1

Choosing Targeted Therapy Based on a Tumor's <span class="highlight">Genetic</span> Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's <span class="highlight">genetic</span> profile to select an FDA-approved targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options. You must have results from a <span class="highlight">genomic</span> or immunohistochemistry test approved by TAPUR. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's <span class="highlight">genetic</span> profile.</p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's <span class="highlight">genetic</span> profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Futibatinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO: TAPUR Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/clinical-trials/what-tapur-study' target='_blank'>Cancer.Net (Video): What is the TAPUR Study?</a> </li><li class='seamTextUnorderedListItem'><a href='https://old-prod.asco.org/research-data/tapur-study/study-participation' target='_blank'>ASCO: TAPUR Study Participation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive (Video): About TAPUR</a> </li></ul>
1

Choosing Targeted Therapy Based on a Tumor's <span class="highlight">Genetic</span> Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study
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Nearest Location:
3 miles
Sutter Cancer Research Consortium
San Francisco, CA

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Visits:
Coincides with targeted therapy

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ClinicalTrials.gov: NCT02693535

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Phase II

2

ComboMATCH: Targeted Therapy Directed by <span class="highlight">Genetic</span> Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Purpose: To use <span class="highlight">genetic</span> testing to match people to treatments and help doctors plan better treatments.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on <span class="highlight">genetic</span> testing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique <span class="highlight">genetic</span> material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some <span class="highlight">genetic</span> changes or abnormalities (mutations) may benefit from treatment that targets that particular <span class="highlight">genetic</span> mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>
2

ComboMATCH: Targeted Therapy Directed by <span class="highlight">Genetic</span> Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH)
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Nearest Location:
3 miles
UCSF Medical Center-Mission Bay
San Francisco, CA

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT05564377

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Phase II

3

CX-5461 for Advanced Breast Cancer with a BRCA2 or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation

Purpose: To determine the safety and best dose of CX-5461, an experimental targeted therapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have a BRCA2 or PALB2 germline <span class="highlight">(genetic)</span> mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461, by IV, 2 times per month</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461 is an experimental targeted therapy. </li> <li class="seamTextUnorderedListItem">It targets cells with a Homologous Recombination Deficiency (HRD) mutation. </li> <li class="seamTextUnorderedListItem">It works by slowing down the growth of cancer cells or causing cancer cells to die.</li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA2, PALB2</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04890613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/senhwa-biosciences-receives-us-fda-study-may-proceed-letter-to-treat-brca2-or-palb2-solid-tumors-with-cx-5461-301198347.html' target='_blank'>Senhwa Biosciences Press Release: CX-5461</a> </li></ul>
3

CX-5461 for Advanced Breast Cancer with a BRCA2 or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation
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Nearest Location:
339 miles
University of California, Los Angeles
Santa Monica, CA

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Visits:
2 visits per month

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ClinicalTrials.gov: NCT04890613

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Phase I

4

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By <span class="highlight">Genomics</span> (CHARGE)

Purpose: To study the safety, dose, side effects and anti-cancer activity of giving the CDK 4/6 inhibitor ribociclib (Kisqali®) in combination with the chemotherapy belinostat (Beleodaq®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a CDK 4/6 inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®), by IV, 5 days in a row (1 week on, 3 weeks off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ribociclib (Kisqali®) is a type of targeted therapy called a CDK 4/6 inhibitor--it blocks two enzymes, CDK4 and CDK6, that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Ribociclib is approved for use in combination with an aromatase inhibitor to treat postmenopausal women with advanced hormone positive, HER2 negative breast cancer--but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">Belinostat (Beleodaq®) is a type of chemotherapy called an histone deacetylase (HDAC) inhibitor. It is approved for use in some other types of cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04315233' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/belinostat.aspx' target='_blank'>Chemocare.com: Belinostat (Beleodaq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617008.html' target='_blank'>MedLinePlus: Ribociclib (Kisqali®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/cdk4-6-inhibitors-make-headway-in-her2-and-triple-negative-breast-cancers' target='_blank'>OncLive: CDK4/6 Inhibitors Make Headway in HER2+ and Triple-Negative Breast Cancers</a> </li></ul>
4

Ribociclib and Belinostat for Advanced Triple Negative Breast Cancer

A Phase I/Ib Trial of the CDK4/6 Antagonist Ribociclib And The HDAC Inhibitor Belinostat In Patients With Metastatic Triple Negative Breast Cancer And Recurrent Ovarian Cancer With Response Prediction By <span class="highlight">Genomics</span> (CHARGE)
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Nearest Location:
602 miles
Huntsman Cancer Institute
Salt Lake City, UT

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Visits:
5 visits a month, ongoing

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ClinicalTrials.gov: NCT04315233

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Phase I

5

PARP Inhibitor Olaparib and the Chemotherapy Vorinostat for Advanced HER2 Negative Breast Cancer

Multicenter Phase I/Ib Trial of Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer

Purpose: To study the safety, dose, and anti-cancer activity of giving a PARP inhibitor in combination with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat metastatic HER2 negative breast cancer in people with a BRCA 1/2 <span class="highlight">genetic</span> (inherited) mutation. However, the use of olaparib in this trial is considered investigational. </li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®) is chemotherapy approved to treat a type of cancer called T-cell lymphoma. Its use in this trial is considered investigational.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742245' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Vorinostat.aspx' target='_blank'>Chemocare: Vorinostat</a> </li></ul>
5

PARP Inhibitor Olaparib and the Chemotherapy Vorinostat for Advanced HER2 Negative Breast Cancer

Multicenter Phase I/Ib Trial of Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer
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Nearest Location:
1643 miles
Houston Methodist Cancer Center
Houston, TX

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT03742245

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Phase I

6

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers

Purpose: To study the safety and best dose of gene therapy with KK-LC-1 TCR T cells, an experimental immunotherapy.

Who is this for?: People with KK-LC-1 positive (KK-LC-1+) metastatic (stage IV) breast cancer with a HLA mutation that has progressed on standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis procedure</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, daily, 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, daily, 5 days</li> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells, by injection, 1 session</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily, 4 days</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for 3-4 weeks</li> <li class="seamTextUnorderedListItem">May require follow-up visits every 3-6 months for up to 5 years</li> <li class="seamTextUnorderedListItem">May require questionnaires for up to 15 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts <span class="highlight">genetic</span> material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">Gene therapy with KK-LC-1 T cell receptor (TCR) T cells is an experimental type of immunotherapy that trains the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">About 75% of triple negative breast cancer is KK-LC-1 positive.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect specific immune cells called T cells that will be modified to target cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an injection into your tumor.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05035407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/therapy/genetherapy/#:~:text=Gene%20therapy%20is%20a%20medical,of%20using%20drugs%20or%20surgery.' target='_blank'>MedlinePlus: What is Gene Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>National Cancer Institute: T Cell Transfer Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41598-018-24514-9' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>
6

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers
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Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Requires hospitalization

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ClinicalTrials.gov: NCT05035407

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Phase I

7

T Cell Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells <span class="highlight">Genetically</span> Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of an experimental T cell therapy using a person's own modified white blood cells with an experimental vaccine.

Who is this for?: People with stage IV (metastatic) breast cancer with a KRAS mutation who have received at least 2 lines of therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 days</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 days</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 1-4 days</li> <li class="seamTextUnorderedListItem">T cells, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Vaccine, by injection, 3-4 times</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many cancer cells produce substances (antigens) that are unique to each cancer and stimulate the body's immune responses.</li> <li class="seamTextUnorderedListItem">Taking disease-fighting white blood cells (T cells) from a person, changing those cells so they will target the specific proteins (antigens) from the cancer cells, and returning them to that person's blood is a form of gene therapy.</li> <li class="seamTextUnorderedListItem">A vaccine may help these modified white cells work better.</li> <li class="seamTextUnorderedListItem">Leukapheresis is when blood is removed from the body, white blood cells are separated, and the remaining blood is returned to the body.</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®) and cyclophosphamide (Cytoxan®) are chemotherapy drugs that make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin is a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>
7

T Cell Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells <span class="highlight">Genetically</span> Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer
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Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Requires hospitalization for 3-4 weeks

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ClinicalTrials.gov: NCT06253520

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Phase I

8

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Administration of Autologous T-Cells <span class="highlight">Genetically</span> Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer

Purpose: To study the safety and effects (good and bad) of an immunotherapy that uses personalized T cells.

Who is this for?: People with metastatic (stage IV) breast cancer for which standard treatments have not worked. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be in the hospital and receive the following: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Before hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells), 2-4 months before receiving treatment</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Hospital stay for receiving treatment (2-3 weeks):</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, once a day, for 2 days </li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara), by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Followed by Aldesleukin, by IV, once every 8 hours, for up to 4 days </li> <li class="seamTextUnorderedListItem">TCR-Transduced T-Cells, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">After hospital stay:</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic and antiviral, for at least 6 months</li> <li class="seamTextUnorderedListItem">Screening tests, every few months for the first year, every 6 months for the second year, then as determined</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">To create the personalized T cells, cancer cells will be taken from your tumor and white blood cells will be removed from your blood. </li> <li class="seamTextUnorderedListItem">The cancer cells will be analyzed to learn about the <span class="highlight">genetic</span> mutations they contain. </li> <li class="seamTextUnorderedListItem">In a lab, your white blood cells will be modified in ways that will help them go after your tumor cells. </li> <li class="seamTextUnorderedListItem">They will then be infused into your body. This will take place in the hospital where the research study is taking place. </li> <li class="seamTextUnorderedListItem">When you receive the infused T cells, you will also be given Aldesleukin, an immune function enhancing drug. </li> <li class="seamTextUnorderedListItem">Your treatment will also include two chemotherapy drugs: cyclophosphamide (Cytoxan), which is used to treat breast cancer, and fludarabine (Fludara), which is approved to treat chronic lymphocytic leukemia (CLL). </li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of metastatic cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03412877' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2014/ACTepithelial' target='_blank'>National Cancer Institute Press Release: Immunotherapy</a> </li></ul>
8

Using Personalized T-Cells Along with Chemotherapy to Treat Metastatic Breast Cancer

Administration of Autologous T-Cells <span class="highlight">Genetically</span> Engineered to Express T-Cell Receptors Reactive Against Mutated Neoantigens in People With Metastatic Cancer
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Nearest Location:
2432 miles
National Institutes of Health Clinical Center
Bethesda, MD

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Visits:
Hospital stay for up to 9 days; screening test every few months for 2 years

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ClinicalTrials.gov: NCT03412877

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Phase II

9

Keytruda for Advanced Breast Cancer in People With a BRCA1/2 Tumor Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and <span class="highlight">Genomic</span> Instability

Purpose: To study the effects (good and bad) of using an immunotherapy drug to treat cancer that has spread outside the breast to nearby tissue or lymph nodes or to other parts of the body.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have been tested for and found to have a BRCA 1 or BRCA 2 tumor mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug is pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). </li> <li class="seamTextUnorderedListItem">Keytruda® is currently approved to treat certain types of cancers.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03428802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/july-10-2017/pembrolizumab-moving-forward-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/parp-inhibitor-may-prolong-survival-in-metastatic-brcapositive-breast-cancer' target='_blank'>Cure Today: Parp Inhibitor May Prolong Survival</a> </li></ul>
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Keytruda for Advanced Breast Cancer in People With a BRCA1/2 Tumor Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and <span class="highlight">Genomic</span> Instability
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Nearest Location:
2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick, NJ

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT03428802

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Phase II

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