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| ID | Type | Description | Link |
|---|---|---|---|
| MK-1022-010 | Other Identifier | MSD | |
| 2024-514376-40-00 | Registry Identifier | EU CT | |
| U1111-1307-7867 | Registry Identifier | UTN |
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| Name | Class |
|---|---|
| Daiichi Sankyo | INDUSTRY |
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Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin | Experimental | In Part 1, participants receive neoadjuvant pembrolizumab 200 mg via intravenous (IV) infusion every 3 weeks (Q3W) plus patritumab deruxtecan via IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg via IV infusion Q3W plus paclitaxel 80 mg/m^2 via IV infusion every week (QW) and carboplatin AUC1.5 mg/ml/min via IV infusion QW for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. |
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| Part 2, A: Pembrolizimab + patritumab deruxtecan → Pembrolizumab + paclitaxel + carboplatin | Experimental | In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion every Q3W plus patritumab deruxtecan (dose to be determined in part 1) IV infusion Q3W for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min IV infusion QW for 12 weeks. At 3-6 weeks after last dose of neoadjuvant treatment, participants undergo surgery for breast cancer. After surgery, participants receive adjuvant pembrolizumab 400 mg IV every 6 weeks (Q6W) for ~30 weeks. Additional adjuvant treatment of physician's choice (TPC) may be given to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline BRCA mutation [gBRCAm] only), capecitabine 1000-1250 mg/m^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV Q3W or every 2 weeks (Q2W) and cyclophosphamide 600 mg/m^2 IV Q3W or Q2W for 4 doses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patritumab deruxtecan | Biological | Administered via IV infusion as neoadjuvant treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Number of Participants Experiencing an Adverse Event (AE) | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 1. | Up to ~43 weeks |
| Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs) | A DLT is defined by the National Cancer Institute Common Terminology for Adverse Events (NCI CTCAE) Version 5.0, assessed by investigator as drug-related: Grade (gr) 3 or 4 nonhematologic toxicity (with exceptions); gr 3 or gr 4 laboratory values (with exceptions); gr 3 or 4 febrile neutropenia; prolonged delay (>2 weeks) in initiating Cycle 2 (cycle length = 3 weeks) due to intervention-related toxicity; any intervention-related toxicity that causes the participant to discontinue intervention during Cycle 1; interstitial lung disease as per investigator; any other gr ≥3 pulmonary toxicity; or gr 5 toxicity. | Up to 21 days |
| Part 1: Number of Participants who Discontinued Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 1. | Up to ~30 weeks |
| Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0 | pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery. | Up to ~30 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0 | pCR-no DCIS (ypT0 ypN0) is defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy at the time of definitive surgery. | Up to ~30 weeks |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Hematology/Oncology - Parkside ( Site 0021) | Recruiting | Santa Monica | California | 90404 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
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Part 1 is non-randomized. Part 2 is randomized 1:1:1.
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| Part 2, B: Pembrolizumab + paclitaxel + carboplatin → Pembrolizumab + patritumab deruxtecan | Experimental | In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus patritumab deruxtecan (dose to be determined in part 1) via IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for ~30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only), capecitabine 1000-1250 mg/m^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles or doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV infusion Q3W or Q2W and cyclophosphamide 600 mg/m^2 IV infusion Q3W or Q2W for 4 doses. |
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| Part 2, C: Pembro + paclitaxel + carboplatin→ Pembro + doxorubicin (or epirubicin) +cyclophosphamide | Active Comparator | In Part 2, participants receive neoadjuvant pembrolizumab 200 mg IV infusion Q3W plus paclitaxel 80 mg/m^2 IV infusion QW and carboplatin AUC1.5 mg/ml/min via IV infusion QW for 12 weeks, followed by pembrolizumab 200 mg IV infusion Q3W plus doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV infusion Q3W and cyclophosphamide 600 mg/m^2 IV infusion Q3W for 12 weeks. At 3 to 6 weeks after last dose of neoadjuvant treatment, participants will undergo surgery for their breast cancer. After surgery, participants will receive adjuvant pembrolizumab 400 mg IV infusion Q6W for approximately 30 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options include olaparib 300 mg oral BID for 1 year (participants with gBRCAm only) or capecitabine 1000-1250 mg/m^2 oral BID days 1-14 and 22-35 Q6W for 4 six-week cycles. |
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| Pembrolizumab | Biological | Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2 |
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| Paclitaxel | Drug | Administered via IV infusion as neoadjuvant treatment |
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| Carboplatin | Drug | Administered via IV infusion as neoadjuvant treatment |
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| Doxorubicin hydrochloride | Drug | Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2 |
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| Epirubicin hydrochloride | Drug | Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2 |
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| Cyclophosphamide | Drug | Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2 |
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| Capecitabine | Drug | Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2 |
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| Olaparib | Drug | Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2 |
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| Part 2: Number of Participants Experiencing an AE |
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented for Part 2. |
| Up to ~103 weeks |
| Part 2: Number of Participants who Discontinued Study Treatment Due to an AE | An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinued study treatment due to an AE will be presented for Part 2. | Up to ~90 weeks |
| Part 2: Event-Free Survival (EFS) | EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first. | Up to ~100 months |
| Part 2: Overall Survival (OS) | OS is defined as the time from randomization to date of death due to any cause. | Up to ~100 months |
| Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS) | DPDRFS is defined as the time from randomization to first distant progression or distant recurrence event as assessed or death due to any cause, whichever occurs first. | Up to ~100 months |
| Part 2: Residual Cancer Burden (RCB) | RCB is defined as residual disease in either the breast or lymph node at the time of surgery. RCB score provides a continuous measurement of the extent of residual cancer. There are four RCB classes: RCB-0 (RCB score 0), RCB-1 (0< RCB score <1.36), RCB-2 (1.36 <RCB score <3.28), and RCB-3 (RCB score >3.28). | Up to ~30 weeks |
| Orchard Healthcare Research Inc. ( Site 0006) | Recruiting | Skokie | Illinois | 60077 | United States |
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| Intermountain Health St. Vincent Regional Hospital - Cancer Centers of Montana ( Site 0003) | Recruiting | Billings | Montana | 59102 | United States |
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| Northwest Cancer Specialists (Compass Oncology) ( Site 8003) | Recruiting | Tigard | Oregon | 97223 | United States |
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| SCRI Oncology Partners ( Site 7000) | Recruiting | Nashville | Tennessee | 37203 | United States |
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| Texas Oncology - DFW ( Site 8000) | Recruiting | Dallas | Texas | 75246 | United States |
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| Houston Methodist Hospital ( Site 0022) | Recruiting | Houston | Texas | 77030 | United States |
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| Virginia Oncology Associates (VOA) ( Site 8001) | Recruiting | Norfolk | Virginia | 23502 | United States |
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| Seoul National University Hospital ( Site 2400) | Recruiting | Seoul | 03080 | South Korea |
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| Severance Hospital, Yonsei University Health System ( Site 2402) | Recruiting | Seoul | 03722 | South Korea |
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| Asan Medical Center ( Site 2401) | Recruiting | Seoul | 05505 | South Korea |
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| Institut Català d'Oncologia (ICO) - Badalona ( Site 1700) | Recruiting | Badalona | Catalonia | 08916 | Spain |
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| Clinica Universidad de Navarra ( Site 1703) | Recruiting | Madrid | Madrid, Comunidad de | 28027 | Spain |
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| Hospital Universitario Reina Sofia ( Site 1702) | Recruiting | Córdoba | 14004 | Spain |
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| Taichung Veterans General Hospital ( Site 2502) | Recruiting | Taichung | 407 | Taiwan |
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| National Cheng Kung University Hospital ( Site 2503) | Recruiting | Tainan | 704 | Taiwan |
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| Koo Foundation Sun Yat-Sen Cancer Center ( Site 2501) | Recruiting | Taipei | 112 | Taiwan |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000710748 | patritumab deruxtecan |
| C582435 | pembrolizumab |
| D017239 | Paclitaxel |
| D016190 | Carboplatin |
| D004317 | Doxorubicin |
| D015251 | Epirubicin |
| D003520 | Cyclophosphamide |
| D000069287 | Capecitabine |
| C531550 | olaparib |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D056831 | Coordination Complexes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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