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1

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 deruxtecan-nxki (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), or datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®).</li></ul></span>

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>
1

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 from 94107:
3 miles
University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
San Francisco, CA

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Visits:
Monthly

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ClinicalTrials.gov: NCT06982521

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Phase III

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 deruxtecan (Enhertu®), datopotamab deruxtecan <span class="highlight">(Datroway®),</span> 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 from 94107:
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

Dexamethasone Mouthwash to Prevent Mouth Sores During Datopotamab Deruxtecan Treatment for Metastatic Breast Cancer

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)

Purpose: To study the effects (good and bad) of whether a dexamethasone mouthwash can help prevent or reduce mouth sores (stomatitis) caused by datopotamab deruxtecan (Dato-DXd, <span class="highlight">Datroway®).</span>

Who is this for?: People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+) HER2 negative (HER2-) or triple-negative breast cancer (ER-, PR-, HER2-). You must not have received datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®)</span> for your metastatic breast cancer. You must not have an active, uncontrolled mouth infection or sores at the start of the trial. This trial is also enrolling people with other types of cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dexamethasone mouthwash: by mouth, 4 times a day</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dato-DXd is an antibody-drug conjugate that can cause painful mouth sores as a side effect. This trial is studying dexamethasone mouthwash, a steroid rinse used in the mouth to calm inflammation. </li> <li class="seamTextUnorderedListItem">The trial will track how often these mouth sores happen, how severe they are, and how well patients tolerate using the mouthwash during the first 12 weeks of Dato-DXd treatment.</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/NCT07357597' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lbbc.org/about-breast-cancer/side-effects/mouth-sores' target='_blank'>Living Beyond Breast Cancer: Mouth sores</a> </li></ul>
3

Dexamethasone Mouthwash to Prevent Mouth Sores During Datopotamab Deruxtecan Treatment for Metastatic Breast Cancer

A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)
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Nearest Location from 94107:
342 miles
Research Site
Glendale, CA

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Visits:
Number of visits unavailable, up to 12 weeks

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ClinicalTrials.gov: NCT07357597

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Phase IV

4

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 deruxtecan-nxki (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), and datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®).</li></ul></span>

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>
4

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 from 94107:
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

5

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 datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®)</span> 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 deruxtecan-nxki (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), or datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®)</span> 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">Datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®),</span> 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 deruxtecan (Dato-DXd; <span class="highlight">Datroway®)</span> 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>
5

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 from 94107:
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

6

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 deruxtecan-nxki (Enhertu®), sacituzumab govitecan-hziy (Trodelvy®), or datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®)</span> 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>
6

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 from 94107:
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

7

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

Prevention of Datopotamab Deruxtecan (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 datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®).</span>

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">Datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®),</span> 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 deruxtecan (Dato-DXd; <span class="highlight">Datroway®)</span> 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 datopotamab deruxtecan (Dato-DXd; <span class="highlight">Datroway®)</span> 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>
7

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

Prevention of Datopotamab Deruxtecan (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 from 94107:
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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