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1

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

A Phase II Non-comparative Trial of <span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> (Dato-DXd) or Trastuzumab <span class="highlight">Deruxtecan</span> (T-DXd) in Patients with Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy (TRADE DXd)

Purpose: To test the safety and effectiveness of the sequence of 2 types of antibody drug conjugates (ADCs) to learn whether the treatment works for people with metastatic HER2 low breast cancer.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 low breast cancer. You must not have received more than 2 lines of chemotherapy or antibody drug conjugates 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</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab <span class="highlight">deruxtecan</span> (T-DXd, Enhertu®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> followed by (after progression): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> followed by (after progression): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab <span class="highlight">deruxtecan</span> (T-DXd, Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">MRI scans, every 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab <span class="highlight">deruxtecan</span> (T-DXd, Enhertu®) and <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd) are antibody drug conjugates (ADCs).</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 <span class="highlight">deruxtecan</span> (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called <span class="highlight">deruxtecan.</li></span> <li class="seamTextUnorderedListItem">Datopotamab <span class="highlight">deruxtecan</span> (Dato-DXd)'s antibody targets TROP2 and delivers an anti-cancer drug called <span class="highlight">deruxtecan.</li></span> <li class="seamTextUnorderedListItem">The US FDA has not approved <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> as a treatment for HER2-low metastatic breast cancer.</li> <li class="seamTextUnorderedListItem">The US FDA has approved trastuzumab <span class="highlight">deruxtecan</span> (Enhertu®) for previously treated HER2-low metastatic breast cancer, and for other uses.</li> <li class="seamTextUnorderedListItem">If you are randomized to a group and have already received the first drug, you may immediately skip to the second drug.</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/NCT06533826' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
1

Sequence of Two ADCs for Advanced HER2 Low Breast Cancer

A Phase II Non-comparative Trial of <span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> (Dato-DXd) or Trastuzumab <span class="highlight">Deruxtecan</span> (T-DXd) in Patients with Metastatic HER2-low Breast Cancer After Progression on Prior Antibody Drug Conjugate Therapy (TRADE DXd)
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Nearest Location:
3 miles
University of San Francisco
San Francisco, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT06533826

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Phase II

2

MBRC-201 Antibody-Drug Conjugate for Metastatic Breast Cancer

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of MBRC-201 antibody-drug conjugate.

Who is this for?: People with metastatic (stage IV) breast cancer that is resistant to standard therapies. You must not have received trastuzumab <span class="highlight">deruxtecan</span> (Enhertu®), <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Datroway®), or sacituzumab govitecan (Trodelvy®). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MBRC-201</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is 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/NCT07145255' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbracetrx.com/clinical-program-mbrc-201/' target='_blank'>MBrace Therapeutics: MBRC-201</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates (ADC)</a> </li></ul>
2

MBRC-201 Antibody-Drug Conjugate for Metastatic Breast Cancer

A Multicenter, Open-label Phase 1/2 Dose Finding, Safety, and Pharmacokinetic Study of MBRC-201, an Antibody-drug Conjugate, in Advanced Refractory Solid Tumors
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Nearest Location:
3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

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Visits:
Number of visits unavailable, up to 2 years

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ClinicalTrials.gov: NCT07145255

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Phase I-II

3

RLY-2608 PI3Kα Inhibitor Plus Fulvestrant Versus Capivasertib AKT Inhibitor Plus Fulvestrant for Advanced PIK3CA-Mutant HR+, HER2- Breast Cancer

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Tr...(ReDiscover-2)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of RLY-2608 PI3Kα inhibitor plus fulvestrant (Faslodex®) hormone therapy versus capivasertib (Truqap®) AKT inhibitor plus fulvestrant (Faslodex®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation whose cancer has progressed while receiving 1 or 2 lines of hormone therapy and a CDK4/6 inhibitor. You must not have received certain treatments that are listed below. 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">RLY-2608, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capivasertib (Truqap®), by mouth, daily, 4 days on 3 days off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, monthly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <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">Capivasertib (Truqap®) is used to treat HR+, HER2- advanced breast cancer with a mutation in PIK3CA, AKT1, or PTEN.</li> <li class="seamTextUnorderedListItem">RLY-2608 is an experimental treatment being tested to treat HR+, HER2- advanced breast cancer with a mutation in PIK3CA.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</li> <li class="seamTextUnorderedListItem">To be eligible for this trial, you must not have received any of the following treatments: alpelisib (Piqray®), capivasertib (Truqap®), pembrolizumab (Keytruda®), dostarlimab-gxly (Jemperli®), fam-trastuzumab <span class="highlight">deruxtecan-nxki</span> (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), or <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®).</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/NCT06982521' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://relaytx.com/pipeline/#hero-scroll' target='_blank'>Relay Therapeutics: RLY-2608</a> </li></ul>
3

RLY-2608 PI3Kα Inhibitor Plus Fulvestrant Versus Capivasertib AKT Inhibitor Plus Fulvestrant for Advanced PIK3CA-Mutant HR+, HER2- Breast Cancer

A Phase 3 Open-Label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Tr...(ReDiscover-2)
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Nearest Location:
3 miles
University of California San Francisco
San Francisco, CA

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Visits:
Monthly

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ClinicalTrials.gov: NCT06982521

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Phase III

4

Dato-DXd ADC With or Without Durvalumab Immunotherapy for Advanced Triple Negative, PD-L1 Positive Breast Cancer

A Phase III, Open-label, Randomised Study of <span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast (TROPION-Breast05)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd), an experimental antibody drug conjugate (ADC), with or without durvalumab immunotherapy compared to standard of care chemotherapy with pembrolizumab immunotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), PD-L1 positive 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 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd), by IV</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab <span class="highlight">deruxtecan</span> (Dato-DXd) is an experimental 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">Datopotamab <span class="highlight">deruxtecan's</span> antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called <span class="highlight">deruxtecan.</li></span> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) and pembrolizumab (Keytruda®) are a type of immunotherapy called PD-1 inhibitors, which are a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">In this trial, standard of care chemotherapy drugs include carboplatin (Paraplatin®), paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), and/or gemcitabine (Gemzar®).</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/NCT06103864' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.astrazenecaclinicaltrials.com/study/D7630C00001/' target='_blank'>AstraZeneca: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2022-supplement-breast-cancer-almanac/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Datopotamab Deruxtecan (Dato-DXd)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/news/conference-coverage/asco-2021/asco-2021-breast-cancer-in-depth/breast-cancer-durvalumab-neoadjuvant-chemo-treatment-risk/#:~:text=June%2024%2C%202021-,Durvalumab%20Improves%20Survival%20When%20Added%20to,in%2' target='_blank'>Cancer Therapy Advisor: Durvalumab (Imfinzi®)</a> </li></ul>
4

Dato-DXd ADC With or Without Durvalumab Immunotherapy for Advanced Triple Negative, PD-L1 Positive Breast Cancer

A Phase III, Open-label, Randomised Study of <span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast (TROPION-Breast05)
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Nearest Location:
74 miles
Research Site
Sacramento, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06103864

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Phase III

5

Bulumtatug Fuvedotin Antibody-Drug Conjugate for Advanced Triple-Negative Breast Cancer

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of bulumtatug fuvedotin antibody-drug conjugate.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received no more than 3 lines of therapy. Past treatment must have included a taxane and certain antibody-drug conjugates. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bulumtatug fuvedotin, by IV, weekly, 2 weeks on 1 week off</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bulumtatug fuvedotin is an antibody-drug conjugate that targets a protein called nectin-4 that is present on cancer cells.</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">Taxanes are paclitaxel (Taxol®) and docetaxel (Taxotere®).</li> <li class="seamTextUnorderedListItem">You must have received one of these antibody-drug conjugates: fam-trastuzumab <span class="highlight">deruxtecan-nxki</span> (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), and <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®).</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/NCT06908928' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mabwell.com/en/rd.html' target='_blank'>Mabwell: Bulumtatug Fuvedotin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li></ul>
5

Bulumtatug Fuvedotin Antibody-Drug Conjugate for Advanced Triple-Negative Breast Cancer

An Open-Label, Multicenter, Phase Ib Dose Randomization Study of Bulumtatug Furvedotin (BFv; 9MW2821) in Subjects With Recurrent or Metastatic Triple-Negative Breast Cancer Previously Treated With Antibody-Drug Conjugates
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Nearest Location:
353 miles
City of Hope
Duarte, CA

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Visits:
2 visits every 3 weeks for 2 years

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ClinicalTrials.gov: NCT06908928

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Phase I

6

Dato-DXd for Advanced HR+, HER2- Breast Cancer

A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®) antibody-drug conjugate.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that has become resistant to hormone therapy. You must not have received chemotherapy, fam-trastuzumab <span class="highlight">deruxtecan-nxki</span> (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), or <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®) for your advanced cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®), by IV, every 3 weeks, up to 5 years</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In this study, HER2- is defined as IHC 0 (no staining or incomplete and faint/barely perceptible membrane staining in ≤10% of tumor cells).</li> <li class="seamTextUnorderedListItem">Datopotamab <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®) is an antibody-drug conjugate (ADC). An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</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/NCT07205822' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://datroway.com/?gclsrc=aw.ds&gad_source=1&gad_campaignid=22411693368&gbraid=0AAAAA-nL_-fHlfedCQ0wuAVgecBaDMC80&gclid=CjwKCAiA0eTJBhBaEiwA-Pa-hbSesNEE7n09CdOw1ZrQBMl6NMyWMeF6MMPq4fD30xu3Pn1CBF7EIRoCWUsQAvD_BwE' target='_blank'>Daiichi Sankyo: Datopotamab Deruxtecan (Dato-DXd; Datroway®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li></ul>
6

Dato-DXd for Advanced HR+, HER2- Breast Cancer

A Phase IIIb, Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HRpositive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)
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Nearest Location:
649 miles
Research Site
Puyallup, WA

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Visits:
Every 3 weeks up to 5 years

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ClinicalTrials.gov: NCT07205822

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Phase III

7

Changing the Dose of Capecitabine According to Scans to Control Metastatic ER+, HER2- Breast Cancer

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of changing the dose of capecitabine (Xeloda®) chemotherapy according to the results of scans.

Who is this for?: People with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer. You must not have received chemotherapy or fam-trastuzumab <span class="highlight">deruxtecan-nxki</span> (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), or <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®) for your metastatic breast cancer. You must not have uncontrolled brain metastases. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth</li> <li class="seamTextUnorderedListItem">Bone scan</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy commonly used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Changing the dose of capecitabine (Xeloda®) according to how the tumor is growing on a scan may allow someone to live longer. This is called <q>adaptive therapy</q>. The goal of adaptive therapy is not to get rid of the entire tumor but to control its growth in a way that helps the patient live longer with a better quality of life.</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/NCT06525766' target='_blank'>ClinicalTrials.gov</a> </li></ul>
7

Changing the Dose of Capecitabine According to Scans to Control Metastatic ER+, HER2- Breast Cancer

Single Arm Pilot Trial of Adaptive Therapy (AT) With Capecitabine for the Treatment of Metastatic Estrogen Receptor Positive, Hormone Refractory Breast Cancer
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Nearest Location:
660 miles
Mayo Clinic in Arizona
Scottsdale, AZ

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Visits:
Number of visits unavailable, up to 5 years

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ClinicalTrials.gov: NCT06525766

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Phase II

8

<span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> ADC for HER2- Breast Cancer That Spread to the Brain or Leptomeninges

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan,</span> an experimental antibody drug conjugate (ADC).

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis) or leptomeninges (leptomeningeal disease). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd), by IV, daily</li> <li class="seamTextUnorderedListItem">CT or MRI scans, every 1-2 months</li> <li class="seamTextUnorderedListItem">Lumbar puncture to collect CSF (optional), 1 time</li> <li class="seamTextUnorderedListItem">Heart scans</li> <li class="seamTextUnorderedListItem">Questionnaires</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab <span class="highlight">deruxtecan</span> (Dato-DXd) is an experimental 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">Datopotamab <span class="highlight">deruxtecan's</span> antibody targets TROP2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called <span class="highlight">deruxtecan.</li></span> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</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/NCT06176261' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/october-10-2022-supplement-breast-cancer-almanac/datopotamab-deruxtecan-shows-activity-in-advanced-triple-negative-breast-cancer/' target='_blank'>ASCO: Dato-DXd</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastastic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>
8

<span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> ADC for HER2- Breast Cancer That Spread to the Brain or Leptomeninges

DATO-BASE: A Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain metAstaSEs
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Nearest Location:
2385 miles
Duke University Medical Center
Durham, NC

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Visits:
At least 1 visit every 1-2 months

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ClinicalTrials.gov: NCT06176261

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Phase II

9

Preventing Mouth Sores Due to Dato-DXd With Dexamethasone Mouthwash for Advanced HR+, HER2- or Triple Negative Breast Cancer

Prevention of <span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

Purpose: To study if a dexamethasone mouthwash can prevent mouth sores following treatment with <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer whose cancer has progressed on at least one line of therapy OR people with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer whose cancer has progressed on hormone therapy and a CDK 4/6 inhibitor and 1 prior line of chemotherapy and/or antibody-drug conjugate (ADC). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem"><span class="highlight">Datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash, 5 days per week for 2 months</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Datopotamab <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®) is an antibody-drug conjugate (ADC), which 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">A common side effect of <span class="highlight">datopotamab</span> <span class="highlight">deruxtecan</span> (Dato-DXd; Datroway®) is mouth sores and inflammation of the inside of the mouth, called stomatitis.</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitors are palbociclib (Ibrance®), ribociclib (Kisqali®), and abemaciclib (Verzenio®).</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/NCT06974604' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/digestive-system/?utm_medium=email&utm_source=subscribers&utm_campaign=Dec2024&utm_content=Email122024' target='_blank'>Metastatic Trial Talk: Managing Side Effects of Treatment: Digestive System Problems</a> </li><li class='seamTextUnorderedListItem'><a href='https://datroway.com/?gclsrc=aw.ds&gad_source=1&gad_campaignid=22411693368&gbraid=0AAAAA-nL_-d3XIFfFFEx4zohhCrXvhfIZ&gclid=Cj0KCQiAjJTKBhCjARIsAIMC4481LG5Jq8xB9UdmzCJ1we3heac32-SwjTGI7Na6ktS2O8VU50e0DxoaAjnfEALw_wcB' target='_blank'>Daiichi Sankyo: Datopotamab Deruxtecan (Dato-DXd; Datroway®)</a> </li></ul>
9

Preventing Mouth Sores Due to Dato-DXd With Dexamethasone Mouthwash for Advanced HR+, HER2- or Triple Negative Breast Cancer

Prevention of <span class="highlight">Datopotamab</span> <span class="highlight">Deruxtecan</span> (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)
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Nearest Location:
2684 miles
Rhode Island and the Miriam Hospitals (Brown University Health)
Providence, RI

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Visits:
Every 3 weeks

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ClinicalTrials.gov: NCT06974604

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Phase II

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