DOXORUBICIN HYDROCHLORIDE for Triple negative breast cancer | Hormone receptor low positive HER2-negative breast cancer | Early-stage high-risk breast cancer

Inclusion criteria

• {"criterion_text":"- Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2\n- Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm\n- Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load\n- Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable\n- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 28 days prior to allocation/randomization\n- Has left ventricular ejection fraction (LVEF) of ≥50% or ≥ lower limit of normal (LLN) as assessed by echocardiogram (ECHO) or multigate acquisition scan (MUGA) scan"}

Exclusion criteria

• {"criterion_text":"- Has uncontrolled or significant cardiovascular disease before randomization\n- Has clinically significant corneal disease\n- Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease\n- Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor\n- Has received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed breast cancer\n- Has received prior treatment with an anti-human epidermal growth factor receptor 3 (HER3) antibody and/or antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g., trastuzumab deruxtecan)\n- Has metastatic (Stage IV) breast cancer or cN3 nodal involvement\n- Has known additional malignancy that is progressing or has required active treatment within the past 5 years\n- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis\n- Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease, or where suspected ILD/pneumonitis cannot be ruled out by standard diagnostic assessments\n- Has an active infection requiring systemic therapy\n- Has concurrent active HBV and HCV infection\n- Has clinically severe respiratory compromise resulting from intercurrent pulmonary illness"}

Primary endpoints

• {"endpoint_text":"- Part 1: Number of Participants Experiencing an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any AE (no further measurement definition provided in CTIS JSON)."}
• {"endpoint_text":"- Part 1: Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLTs)","definition_or_measurement_approach":"DLT evaluation is included in trial scope; no detailed DLT definition provided in the CTIS JSON."}
• {"endpoint_text":"- Part 1: Number of Participants who Discontinued Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants discontinuing study treatment due to an AE (no additional measurement detail provided)."}
• {"endpoint_text":"- Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0","definition_or_measurement_approach":"pCR defined as ypT0/Tis ypN0 at time of definitive surgery, as assessed by local pathologist."}
• {"endpoint_text":"- Part 2: Number of Participants Experiencing an Adverse Event (AE)","definition_or_measurement_approach":"Count of participants experiencing any AE in Part 2 (no further measurement definition provided)."}
• {"endpoint_text":"- Part 2: Number of Participants who Discontinued Study Treatment Due to an AE","definition_or_measurement_approach":"Count of participants discontinuing study treatment due to an AE in Part 2 (no additional measurement detail provided)."}

Secondary endpoints

• {"endpoint_text":"- Part 2: Pathological Complete Response (pCR) Rate Using the Definition of ypT0 ypN0","definition_or_measurement_approach":"pCR using definition ypT0 ypN0 at definitive surgery as assessed by local pathologist."}
• {"endpoint_text":"- Part 2: Event-Free Survival (EFS)","definition_or_measurement_approach":"EFS assessed by investigator; no further definition provided in CTIS JSON."}
• {"endpoint_text":"- Part 2: Overall Survival (OS)","definition_or_measurement_approach":"OS (no further measurement detail provided)."}
• {"endpoint_text":"- Part 2: Distant Progression or Distant Recurrence-Free Survival (DPDRFS)","definition_or_measurement_approach":"DPDRFS assessed by investigator; no further definition provided in CTIS JSON."}
• {"endpoint_text":"- Part 2: Residual Cancer Burden (RCB)","definition_or_measurement_approach":"RCB assessed by local pathologist using the MD Anderson RCB calculator."}

Spain

Earliest CTIS Part Ii Submission Date

31-03-2025

Latest Decision Or Authorization Date

15-01-2026

Processing Time Days

290

Number Of Sites

3

Number Of Participants

10

Primary sponsor

Full Name

Merck Sharp & Dohme LLC

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International Corp.

Responsibilities

EUB services (call center and medical services); sponsorDuties code 15

Name

Pharmaceutical Product Development LLC

Responsibilities

Clinical operations support; sponsorDuties code 4

Name

Pra International

Responsibilities

Sponsor duty code 13 (role as listed)

Name

Icon Clinical Research Limited

Responsibilities

Clinical operations support; sponsorDuties code 4

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [6]; contact Allison.MAYER@3ds.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Pra International","duties_or_roles":"sponsorDuties codes: [13]; contact Christina.fuhrman@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"sponsorDuties codes: [4]; contact Erin.Hubbard@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Hematogenix Laboratory Services LLC","duties_or_roles":"sponsorDuties codes: [4]; contact bcontos@hematogenix.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"sponsorDuties codes: [15]; value: 'EUB services (call center and medical services)'; contact +MSDEMU@parexel.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Ventana Medical Systems Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact karina.vilca@roche.com","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: [4]; contact Victoria.Kiefer@iconplc.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"sponsorDuties codes: [15]; value: 'Adjudication Vendor'; contact Tracey.DSouza@clario.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"sponsorDuties codes: [3]; contact damilola.oyeniran@almacgroup.com","organisation_type":"Pharmaceutical company"}