A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer

Last updated: May 14, 2025
Sponsor: Hoffmann-La Roche
Overall Status: Active - Not Recruiting

Phase

3

Condition

Breast Cancer

Treatment

Trastuzumab Emtansine

Pertuzumab IV

Trastuzumab IV

Clinical Study ID

NCT05415215
MO43110
2021-002346-33
2023-506380-33-00
  • Ages > 18
  • All Genders

Study Summary

This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home setting compared with the hospital setting during the cross-over period of adjuvant treatment in participants with early or locally advanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1

  • Intact skin at planned site of subcutaneous (SC) injections

  • Left ventricular ejection fraction (LVEF) greater than or equal to (≥)55% byechocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)

  • Negative human immunodeficiency virus (HIV) test at screening

  • Negative hepatitis B surface antigen (HBsAg) test at screening

  • Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAbat screening accompanied by either of the following: Negative total hepatitis B coreantibody (HBcAb); Positive total HBcAb test followed by a negative (per locallaboratory definition) hepatitis B virus (HBV) DNA test

  • Negative hepatitis C virus (HCV) antibody test at screening, or positive HCVantibody test followed by a negative HCV RNA test at screening

  • For female participants of childbearing potential: agreement to remain abstinent oruse contraception and agree to refrain from donating eggs during the treatmentperiod and for 7 months after the final dose of the study treatment

  • For male participants: agreement to remain abstinent or use a condom, and agree torefrain from donating sperm during the treatment period and for 7 months after thefinal dose of study treatment

Disease-specific Inclusion Criteria:

  • Female and male participants with stage II-IIIC early or locallyadvanced/inflammatory human epidermal growth factor receptor 2-positive (HER2+)breast cancer

  • Primary tumor >2 centimetres (cm) in diameter, or node-positive disease

  • HER2+ breast cancer confirmed by a local laboratory prior to study enrollment. HER2+status will be determined based on pretreatment breast biopsy material and definedas 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situhybridization (ISH) following American Society of Clinical Oncology (ASCO)/Collegeof American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch PatholLab Med 2018)

  • Hormone receptor status of the primary tumor determined by local assessmentfollowing American Society of Clinical Oncology (ASCO)/College of AmericanPathologists (CAP) guidelines and updates (Allison et al. J Clin Oncol 2020)

  • Agreement to undergo mastectomy or breast conserving surgery after neoadjuvanttherapy, including the axillary nodes

  • Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block forlocal confirmation of HER2 and hormone receptor status following current ASCO/CAPguidelines

Inclusion Criteria for Treatment with Adjuvant PH FDC SC:

  • Completed the neoadjuvant phase of this study and underwent surgery, and achievedpathologic complete response (pCR), defined as eradication of invasive disease inthe breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the localpathologist on the basis of guidelines to be provided in a pathology manual

  • Adequate wound healing after breast cancer surgery per investigator's assessment toallow initiation of study treatment within less than or equal to (≤)9 weeks of lastsystemic neoadjuvant therapy

Exclusion

Exclusion Criteria:

  • Stage IV (metastatic) breast cancer

  • History of concurrent or previously treated non-breast malignancies, except forappropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas,including cervix, colon, and skin. A participant with previous invasive non-breastcancer is eligible provided he/she has been disease free for more than 5 years

  • Participants who are pregnant or breastfeeding or intending to become pregnantduring the study or within 7 months after the final dose of study treatments

  • Treatment with investigational therapy within 28 days prior to initiation of studytreatment

  • Active, unresolved infections at screening requiring treatment

  • Participants who may have had a recent episode of thromboembolism and are stilltrying to optimize the anticoagulation dose and/or have not normalized theirInternational Normalized Ratio (INR)

  • Serious cardiac illness or medical conditions

  • History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias

  • Inadequate bone marrow function

  • Impaired liver function

  • Renal function with creatinine clearance <50 mL/min using the Cockroft-Gault formulaand serum creatinine >1.5x upper limit of normal (ULN)

  • Major surgical procedure unrelated to breast cancer within 28 days prior to studyentry or anticipation of the need for major surgery during the course of studytreatment

  • Current severe, uncontrolled systemic disease that may interfere with plannedtreatment

  • Any serious medical condition or abnormality in clinical laboratory tests thatprecludes an individual's safe participation in and completion of the study

  • Treatment with a live vaccine (e.g., FluMist) in the 30 days prior to initiation ofstudy treatment, or anticipation of need for such a vaccine during treatment orwithin 90 days after the final dose of study treatment

  • Known active liver disease, for example, active viral hepatitis infection,autoimmune hepatic disorders, or sclerosing cholangitis

  • Known hypersensitivity to any of the study drugs, excipients, and/or murine proteinsor a history of severe allergic or immunological reactions, e.g., difficult tocontrol asthma

  • Current chronic daily treatment with corticosteroids

  • Assessment by the investigator as being unable or unwilling to comply with therequirements of the protocol

Cancer-specific Exclusion Criteria for Neoadjuvant Phase:

  • Participants who have received any previous systemic therapy for treatment orprevention of breast cancer, or previous chest irradiation for the treatment ofcancer

  • Participants who have a past history of ductal carcinoma in situ (DCIS) or lobularcarcinoma in situ (LCIS) if they have received any systemic therapy for itstreatment or radiation therapy to the ipsi- or contralateral breast cancer

  • Participants with high-risk for breast cancer who have received chemopreventivedrugs in the past

  • Participants with multicentric breast cancer, unless all tumors are HER2+

  • Participants with bilateral breast cancer

  • Participants who have undergone an excisional biopsy of primary tumor and/oraxillary lymph nodes

  • Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy

  • Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy

Exclusion Criterion for Treatment with Adjuvant Trastuzumab Emtansine (Arm E):

  • Current Grade ≥3 peripheral neuropathy (according to the NCI CTCAE v5.0)

Study Design

Total Participants: 347
Treatment Group(s): 7
Primary Treatment: Trastuzumab Emtansine
Phase: 3
Study Start date:
July 05, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Fundación CENIT para la Investigación en Neurociencias

    Buenos Aires, C1125ABD
    Argentina

    Site Not Available

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE
    Argentina

    Site Not Available

  • Centro Oncologico Korben; Oncology

    Ciudad Autonoma Buenos Aires, C1426AGE
    Argentina

    Site Not Available

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000
    Bosnia and Herzegovina

    Site Not Available

  • Cantonal Hospital Zenica

    Zenica, 72000
    Bosnia and Herzegovina

    Site Not Available

  • Cantonal Hospital Zenica; Department for Oncology

    Zenica, 72000
    Bosnia and Herzegovina

    Site Not Available

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará 60336-550
    Brazil

    Site Not Available

  • Hospital Araujo Jorge; Departamento de Ginecologia E Mama

    Goiania, GO 74605-070
    Brazil

    Site Not Available

  • Hospital Araujo Jorge

    Goiania, Goiás 74605-070
    Brazil

    Site Not Available

  • Hospital Moinhos de Vento

    Porto Alegre, RS 90035-000
    Brazil

    Site Not Available

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande Do Sul 91350-200
    Brazil

    Site Not Available

  • Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

    Sao Paulo, São Paulo 01317-001
    Brazil

    Site Not Available

  • Multiprofile Hospital for Active Treatment Uni Hospital

    Panagyurishte, 4500
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology

    Panagyurishte, 4500
    Bulgaria

    Site Not Available

  • UMHAT Dr Georgi Stranski; Medical Oncology Department

    Pleven, 5800
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment Sveta Marina Pleven OOD

    Pleven, 5800
    Bulgaria

    Site Not Available

  • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • DDODIU-Plovdiv, EOOD; Third Internal Department

    Plovdiv, 4004
    Bulgaria

    Site Not Available

  • MHAT Nadezhda

    Sofia, 1330
    Bulgaria

    Site Not Available

  • Royal Victoria Regional Health Centre

    Barrie, Ontario L4M 6M2
    Canada

    Site Not Available

  • Lakeridge Health Oshawa

    Oshawa, Ontario L1G 2B9
    Canada

    Site Not Available

  • North York General Hospital

    Toronto, Ontario M2K 1E1
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Hopital du Saint Sacrement

    Quebec City, Quebec G1S 4L8
    Canada

    Site Not Available

  • Centro de Estudios Clínicos SAGA

    Santiago,
    Chile

    Site Not Available

  • Clinica Vespucio

    Santiago, 8241479
    Chile

    Site Not Available

  • Hospital Metropolitano (Sede Lindora-Santa Ana)

    San Jose, 10903
    Costa Rica

    Site Not Available

  • Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer

    San Jose, 10903
    Costa Rica

    Site Not Available

  • Clinica CIMCA

    San José, 10103
    Costa Rica

    Site Not Available

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108
    Costa Rica

    Site Not Available

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000
    Croatia

    Site Not Available

  • Max Institute of Cancer Care

    NEW Delhi Delhi, Delhi 110024
    India

    Site Not Available

  • Saifee Hospital

    Mumbai, Maharashtra 400004
    India

    Site Not Available

  • TATA Medical Centre

    Kolkata, WEST Bengal 700156
    India

    Site Not Available

  • TATA Medical Centre; Medical Oncology

    Kolkata, WEST Bengal 700156
    India

    Site Not Available

  • International Cancer Institute (ICI)

    Eldoret, 30100
    Kenya

    Site Not Available

  • Aga Khan University Hospital

    Nairobi, 00100
    Kenya

    Site Not Available

  • Korea University Anam Hospital

    Seoul, 02841
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, 06351
    Korea, Republic of

    Site Not Available

  • Health Pharma Professional Research

    Cdmx, Mexico CITY 03100
    Mexico

    Site Not Available

  • Iem-Fucam

    D.f., Mexico CITY 04980
    Mexico

    Site Not Available

  • Oncologico Potosino

    San Luis Potosí, SAN LUIS Potosi 78209
    Mexico

    Site Not Available

  • Instituto Regional de Enfermedades Neoplásicas del Sur

    Arequipa, 5154
    Peru

    Site Not Available

  • Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica

    Arequipa, 5154
    Peru

    Site Not Available

  • Instituto Nacional de Enfermedades Neoplasicas

    Lima, Lima 34
    Peru

    Site Not Available

  • Oncocenter Peru S.A.C.

    Lima, Lima 41
    Peru

    Site Not Available

  • Oncocenter Peru S.A.C.; Oncosalud

    Lima, Lima 41
    Peru

    Site Not Available

  • Instituto Regional de Enfermedades Neoplasicas - IREN Norte

    Trujillo, 13014
    Peru

    Site Not Available

  • National Cancer Centre

    Singapore, 168583
    Singapore

    Site Not Available

  • National Cancer Centre; Medical Oncology

    Singapore, 168583
    Singapore

    Site Not Available

  • National University Hospital; National University Cancer Institute, Singapore (NCIS)

    Singapore, 119228
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital

    Singapore, 308433
    Singapore

    Site Not Available

  • Tan Tock Seng Hospital; Oncology

    Singapore, 308433
    Singapore

    Site Not Available

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196
    South Africa

    Site Not Available

  • Medical Oncology Centre of Rosebank; Oncology

    Johannesburg, 2196
    South Africa

    Site Not Available

  • University of Pretoria Oncology Department; Medical Oncology

    Pretoria, 0002
    South Africa

    Site Not Available

  • Wilgers Oncology Centre

    Pretoria, 0001
    South Africa

    Site Not Available

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaen, 23007
    Spain

    Site Not Available

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia

    Jaen, 23007
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Arrixaca

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia

    Murcia, 30120
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007
    Spain

    Site Not Available

  • Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

    Salamanca, 37007
    Spain

    Site Not Available

  • Ankara City Hospital

    Ankara, 06800
    Turkey

    Site Not Available

  • Ankara City Hospital; Oncology

    Ankara, 06800
    Turkey

    Site Not Available

  • Gulhane Training and Research Hospital

    Ankara, 06010
    Turkey

    Site Not Available

  • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department

    Edirne, 22770
    Turkey

    Site Not Available

  • Ba?c?lar Medipol Mega Üniversite Hastanesi

    Istanbul, 34214
    Turkey

    Site Not Available

  • Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology

    Istanbul, 34214
    Turkey

    Site Not Available

  • Hacettepe Uni Medical Faculty Hospital

    Sihhiye/Ankara, 06230
    Turkey

    Site Not Available

  • Hacettepe Uni Medical Faculty Hospital; Oncology Dept

    Sihhiye/Ankara, 06230
    Turkey

    Site Not Available

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