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1

PLUMB Registry for Metastatic Lobular Breast Cancer

Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer

Purpose: To create a registry to study metastatic lobular breast cancer, treatment patterns, and overall survival.

Who is this for?: People with stage IV (metastatic) lobular breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples will be used to study the relationship between <span class="highlight">ctDNA</span> and disease progression.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA <span class="highlight">(ctDNA)</span> are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">This trial will also develop an ongoing platform for evaluating new imaging tools, tumor markers, and participant recruitment for clinical trials.</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/NCT05964504' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://clinicaltrials.ucsf.edu/trial/NCT05964504' target='_blank'>University of California, San Francisco: Trial Information Page</a> </li></ul>
1

PLUMB Registry for Metastatic Lobular Breast Cancer

Improving Survival for Those With Metastatic Lobular Breast Cancer Through Development of the Multi-center PLUMB Registry-a Prospective Study of LobUlar Metastatic Breast Cancer
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Nearest Location:
5 miles
University of California, San Francisco
San Francisco, CA

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT05964504

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Phase NA

2

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of giredestrant, an experimental hormone therapy, compared with fulvestrant (Faslodex®) hormone therapy in combination with a CDK4/6 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who not have received treatment (except for surgery or radiation) for advanced disease. View full eligibility criteria

What's involved?

<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">Giredestrant, by mouth, daily</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times in 1 month, then monthly</li> <li class="seamTextUnorderedListItem">CDK inhibitor, by mouth, daily</li> <li class="seamTextUnorderedListItem">FoundationOne Liquid CDx Assay blood test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and giredestrant are a type of hormone therapy called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Giredestrant is an experimental SERD.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), abemaciclib (Verzenio®), ribociclib (Kisqali®) are a type of targeted therapy called CDK 4/6 inhibitors. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">The FoundationOne Liquid CDx Assay blood test will identify <span class="highlight">ctDNA</span> mutations.</li> <li class="seamTextUnorderedListItem">Circulating tumor DNA <span class="highlight">(ctDNA)</span> are small bits of cancer cell DNA that specific tests can find in the bloodstream.</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/NCT06065748' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/serd-3.html#:~:text=This%20compound%20and%20its%20use,US%20Food%20and%20Drug%20Administration.' target='_blank'>Genentech: Giredestrant Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/what-are-cdk46-inhibitors' target='_blank'>Breastcancer.org: CDK4/6 Inhibitors</a> </li></ul>
2

Giredestrant Hormone Therapy with a CDK Inhibitor for Advanced ER+, HER2- Breast Cancer

A Phase III Randomized, Open-Label Study Evaluating Efficacy and Safety of Giredestrant Compared With Fulvestrant, Both Combined With a CDK4/6 Inhibitor, in Patients With Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer With Resistance to Prior Adjuvant Endocrine Therapy
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Nearest Location:
15 miles
Marin Cancer Care Inc
Greenbrae, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06065748

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Phase III

3

Safely Stopping Anti-HER2 Targeted Therapy for People with Advanced HER2+ Breast Cancer Who Are Exceptional Responders

The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients With HER2+ Metastatic Breast Cancer

Purpose: To study if anti-HER2 targeted therapy can be safely stopped in people with HER2 positive metastatic breast cancer that have had an exceptional response to treatment.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer that has not progressed in the last 3 years during treatment with any anti-HER2 targeted therapy as a first line of therapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You can choose to participate in 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Choose to Continue Anti-HER2 Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue anti-HER2 treatment</li> <li class="seamTextUnorderedListItem">Visits, monthly for 2-3 months, then every 3 months</li> <li class="seamTextUnorderedListItem">Imaging scans, every 3 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Choose to Stop Anti-HER2 Treatment</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stop anti-HER2 treatment</li> <li class="seamTextUnorderedListItem">Visits, monthly for 2-3 months, then every 3 months</li> <li class="seamTextUnorderedListItem">Imaging scans, every 3 months</li> </ul> <p class="seamTextPara"> followed 1 year later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stop treatment indefinitely if no progression</li> <li class="seamTextUnorderedListItem">Imaging scans (surveillance), every 3-6 months for 10 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You can choose which group you would like to participate in.</li> <li class="seamTextUnorderedListItem">Exceptional response is considered cancer progression being controlled for 3 years or more since starting anti-HER2 targeted treatment.</li> <li class="seamTextUnorderedListItem">This study is also studying whether blood samples that may contain traces of DNA from cancer, known as circulating tumor DNA <span class="highlight">(ctDNA),</span> are able to help identify which people can successfully stop treatment without a change in their cancer.</li> <li class="seamTextUnorderedListItem">If you have estrogen receptor positive (ER+) breast cancer, you will continue hormone therapy.</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/NCT05721248' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials2/detail/22-655/' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/mbc-exceptional-responder/' target='_blank'>Metastatic Trial Talk: Why Do Some People Have an Exceptional Response When Being Treated for MBC?</a> </li></ul>
3

Safely Stopping Anti-HER2 Targeted Therapy for People with Advanced HER2+ Breast Cancer Who Are Exceptional Responders

The STOP-HER2 Trial: A Phase 2 Study of Stopping Trastuzumab - Outcomes in Patients With HER2+ Metastatic Breast Cancer
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Nearest Location:
650 miles
Mayo Clinic Hospital Arizona
Phoenix, AZ

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Visits:
1 visit every 3 months

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ClinicalTrials.gov: NCT05721248

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Phase II

4

Studying Biomarkers, Immune Cells, and <span class="highlight">ctDNA</span> in People with Brain Metastasis

Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors

Purpose: To study biomarkers, immune cells, and circulating tumor <span class="highlight">(ctDNA)</span> in blood samples after radiation.

Who is this for?: People with metastatic (stage IV) breast cancer that has spread to the brain (brain metastasis) who are planning to receive or receiving radiation at Duke Cancer Center. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will provide the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood samples</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used for genetic testing to indicate the presence of biomarkers, immune cells, and circulating tumor <span class="highlight">(ctDNA).</li></span> <li class="seamTextUnorderedListItem">Circulating tumor DNA <span class="highlight">(ctDNA)</span> are small pieces of cancer cell DNA in the bloodstream.</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/NCT05480644' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
4

Studying Biomarkers, Immune Cells, and <span class="highlight">ctDNA</span> in People with Brain Metastasis

Circulating Biomarkers Repository in Adults Diagnosed With Primary and Metastatic Brain Tumors
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Nearest Location:
2385 miles
Duke Cancer Center
Durham, NC

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Visits:
Coincides with routine care

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ClinicalTrials.gov: NCT05480644

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Phase NA

5

Radiation Therapy, Anti-Estrogen Therapy, and a CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer

Purpose: To study the anti-cancer activity, side effects, and changes to <span class="highlight">ctDNA</span> when giving radiation therapy before the standard of care hormone therapy and a CDK 4/6 inhibitor.

Who is this for?: Postmenopausal women with metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with no more than five metastases (mets). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stereotactic radiation, for 2 weeks</li> <li class="seamTextUnorderedListItem">followed by</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily (3 weeks on, 1 week off), ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is commonly used with anti-estrogen therapy for metastatic, hormone-positive (ER+ and/or PR+), HER2-negative (HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Stereotactic radiation (also called stereotactic radiosurgery) delivers focused radiation to each metastasis (met/tumor).</li> <li class="seamTextUnorderedListItem">Oligometastatic breast cancer is metastatic breast cancer with a small number of metastases.</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/NCT04563507' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/update-on-hormone-receptor-positive-mbc-2021/' target='_blank'>Metastatic Trial Talk: Update on Hormone Receptor-Positive MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: What is Oligometastatic Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/full/10.14694/EdBook_AM.2015.35.e8' target='_blank'>ASCO: Surgery or Ablative Radiotherapy for Breast Cancer Oligometastases</a> </li></ul>
5

Radiation Therapy, Anti-Estrogen Therapy, and a CDK 4/6 Inhibitor for Metastatic HR+, HER2- Breast Cancer

CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer
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Nearest Location:
2567 miles
Weill Cornell Medicine
New York, NY

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04563507

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Phase II

6

<span class="highlight">ctDNA</span> Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study

Purpose: To determine whether switching treatment earlier will increase the amount of time that metastatic breast cancer is controlled.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) or HER2 low breast cancer who have not yet received treatment for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: No Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">ctDNA</span> test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Switch to new treatment (if progression occurs, optional)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Early Treatment Change</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">ctDNA</span> test, monthly for 2 months, then every 2 months</li> <li class="seamTextUnorderedListItem">Standard of care: CDK4/6 inhibitor with aromatase inhibitor or CDK4/6 inhibitor with selective estrogen receptor degrader (SERD)</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Early switch to a new treatment, for 1 year 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Blood tests will be used to indicate tumor biomarkers and the presence of circulating tumor <span class="highlight">(ctDNA).</li></span> <li class="seamTextUnorderedListItem">Circulating tumor DNA <span class="highlight">(ctDNA)</span> are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is define as IHC 1+ or 2+/FISH-.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®) are types of targeted therapy called CDK4/6 inhibitors. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are premenopausal, you must also take a drug that will put women in temporary menopause.</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/NCT05826964' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/ctdna-mbc/' target='_blank'>Metastatic Trial Talk: The Latest Research on ctDNA and MBC</a> </li></ul>
6

<span class="highlight">ctDNA</span> Blood Tests to Determine an Early Switch in Treatment for Metastatic ER+, HER2- or HER2 Low Breast Cancer

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer: A Phase 2 Randomized, Open-Label Study
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Nearest Location:
2591 miles
University of Miami
Miami, FL

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Visits:
At least 1 visit every 2 months

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ClinicalTrials.gov: NCT05826964

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Phase II

7

Free-HER: Stopping Maintenance Anti-HER2 Targeted Therapy for People with Metastatic HER2+ Breast Cancer and No Evidence of Disease

Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer

Purpose: To study if people who stop taking anti-HER2 targeted therapy for maintenance will stay in complete remission.

Who is this for?: People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who have been in complete remission, also called no evidence of disease (NED), for at least 3 years and have been receiving anti-HER2 targeted therapy for at least 3 years. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stop taking anti-HER2 targeted therapy</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Imaging scans</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Complete remission is also known as no evidence of disease (NED).</li> <li class="seamTextUnorderedListItem">Blood tests will measure circulating tumor DNA <span class="highlight">(ctDNA),</span> which are small pieces of cancer cell DNA in the bloodstream.</li> <li class="seamTextUnorderedListItem">You will continue to receive routine monitoring, blood tests, and imaging scans.</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/NCT05959291' 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/herceptin' target='_blank'>Breastcancer.org: What is Anti-HER2 Targeted Therapy?</a> </li></ul>
7

Free-HER: Stopping Maintenance Anti-HER2 Targeted Therapy for People with Metastatic HER2+ Breast Cancer and No Evidence of Disease

Free-HER: Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
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Nearest Location:
2591 miles
University of Miami
Miami, FL

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05959291

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Phase NA

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