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Home sweet home? breast cancer patients may prefer At-Home drug infusions

NCT ID NCT05415215

Symptom relief Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether people with early or locally advanced HER2-positive breast cancer prefer receiving their medication (a combination of pertuzumab and trastuzumab) at home versus in the hospital. About 346 participants were randomly assigned to receive the drug at home or in the hospital for a period, then switched. The main goal was to see which setting they liked more. The study is complete and focuses on patient convenience and preference, not on curing the disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pertuzumab and trastuzumab fixed-dose combination for subcutaneous injection (PH FDC SC)
What this could lead to
If successful, this could show that home administration of this breast cancer drug is preferred by patients, potentially improving convenience and quality of life during treatment.
What could go wrong
This is a completed Phase 3 study, but it focuses on patient preference, not on whether the drug works better or cures the disease. Results may not apply to all patients or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

346 people

The number who actually took part.

Started

Jul 2022

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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% by echocardiogram (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 HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb); Positive total HBcAb test followed by a negative (per local laboratory definition) hepatitis B virus (HBV) DNA test * Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening * For female participants of childbearing potential: agreement to remain abstinent or use contraception and agree to refrain from donating eggs during the treatment period 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 to refrain from donating sperm during the treatment period and for 7 months after the final dose of study treatment Disease-specific Inclusion Criteria: * Female and male participants with stage II-IIIC early or locally advanced/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 defined as 3+ by Immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ hybridization (ISH) following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines 2018 and updates (Wolff et al. Arch Pathol Lab Med 2018) * Hormone receptor status of the primary tumor determined by local assessment following American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines and updates (Allison et al. J Clin Oncol 2020) * Agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy, including the axillary nodes * Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for local confirmation of HER2 and hormone receptor status following current ASCO/CAP guidelines Inclusion Criteria for Treatment with Adjuvant PH FDC SC: * Completed the neoadjuvant phase of this study and underwent surgery, and achieved pathologic complete response (pCR), defined as eradication of invasive disease in the breast and axilla according to the current American Joint Committee on Cancer (AJCC) staging system classification, and using the resected specimen by the local pathologist on the basis of guidelines to be provided in a pathology manual * Adequate wound healing after breast cancer surgery per investigator's assessment to allow initiation of study treatment within less than or equal to (≤)9 weeks of last systemic neoadjuvant therapy Exclusion Criteria: * Stage IV (metastatic) breast cancer * History of concurrent or previously treated non-breast malignancies, except for appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including cervix, colon, and skin. A participant with previous invasive non-breast cancer is eligible provided he/she has been disease free for more than 5 years * Participants who are pregnant or breastfeeding or intending to become pregnant during the study or within 7 months after the final dose of study treatments * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Active, unresolved infections at screening requiring treatment * Participants who may have had a recent episode of thromboembolism and are still trying to optimize the anticoagulation dose and/or have not normalized their International 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 formula and serum creatinine \>1.5x upper limit of normal (ULN) * Major surgical procedure unrelated to breast cancer within 28 days prior to study entry or anticipation of the need for major surgery during the course of study treatment * Current severe, uncontrolled systemic disease that may interfere with planned treatment * Any serious medical condition or abnormality in clinical laboratory tests that precludes 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 of study treatment, or anticipation of need for such a vaccine during treatment or within 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 proteins or a history of severe allergic or immunological reactions, e.g., difficult to control asthma * Current chronic daily treatment with corticosteroids * Assessment by the investigator as being unable or unwilling to comply with the requirements of the protocol Cancer-specific Exclusion Criteria for Neoadjuvant Phase: * Participants who have received any previous systemic therapy for treatment or prevention of breast cancer, or previous chest irradiation for the treatment of cancer * Participants who have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy to the ipsi- or contralateral breast cancer * Participants with high-risk for breast cancer who have received chemopreventive drugs 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/or axillary 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)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma inflammatory breast carcinoma Patient Preference

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Early breast cancer Inflammatory breast cancer Locally advanced breast cancer

Contacts and locations

Locations

  • Ankara City Hospital

    Ankara, 06800, Turkey (Türkiye)

  • Ba?c?lar Medipol Mega Üniversite Hastanesi

    Istanbul, 34214, Turkey (Türkiye)

  • Cantonal Hospital Zenica

    Zenica, 72000, Bosnia and Herzegovina

  • Centro Oncologico Korben

    Ciudad Autonoma Buenos Aires, C1426AGE, Argentina

  • Centro de Estudios Clínicos SAGA

    Santiago, Chile

  • Centro de Investigaciones Médicas y Desarrollo LC S.R.L

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE, Argentina

  • Clinica CIMCA

    San José, 10103, Costa Rica

  • Clinica Vespucio

    Santiago, 8241479, Chile

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

    São Paulo, São Paulo, 01317-001, Brazil

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

    Jaén, 23007, Spain

  • Complex Oncology Center - Plovdiv First Internal Chemotherapy Department

    Plovdiv, 4004, Bulgaria

  • Crio - Centro Regional Integrado de Oncologia

    Fortaleza, Ceará, 60336-550, Brazil

  • Gulhane Training and Research Hospital

    Ankara, 06010, Turkey (Türkiye)

  • Hacettepe Uni Medical Faculty Hospital

    Sihhiye/Ankara, 06230, Turkey (Türkiye)

  • Health Pharma Professional Research

    Mexico City, Mexico City, 03100, Mexico

  • Hopital du Saint Sacrement

    Québec, Quebec, G1S 4L8, Canada

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070, Brazil

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Metropolitano (Sede Lindora-Santa Ana)

    San José, 10903, Costa Rica

  • Hospital Nossa Senhora da Conceicao

    Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

  • Hospital Universitario Virgen de Arrixaca

    Murcia, 30120, Spain

  • ICIMED Instituto de Investigación en Ciencias Médicas

    San José, 10108, Costa Rica

  • Iem-Fucam

    D.F., Mexico City, 04980, Mexico

  • Instituto Regional de Enfermedades Neoplásicas del Sur

    Arequipa, 5154, Peru

  • International Cancer Institute (ICI)

    Eldoret, 30100, Kenya

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2, Canada

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Lakeridge Health Oshawa

    Oshawa, Ontario, L1G 2B9, Canada

  • MHAT Nadezhda

    Sofia, 1330, Bulgaria

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196, South Africa

  • Multiprofile Hospital for Active Treatment Uni Hospital

    Panagyurishte, 4500, Bulgaria

  • National Cancer Centre

    Singapore, 168583, Singapore

  • North York General Hospital

    Toronto, Ontario, M2K 1E1, Canada

  • Oncocenter Peru S.A.C.

    Lima, Lima 41, Peru

  • Oncologico Potosino

    San Luis Potosí City, San Luis Potosí, 78209, Mexico

  • Royal Victoria Regional Health Centre

    Barrie, Ontario, L4M 6M2, Canada

  • Saifee Hospital

    Mumbai, Maharashtra, 400004, India

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • TATA Medical Centre

    Kolkata, West Bengal, 700156, India

  • Tan Tock Seng Hospital

    Singapore, 308433, Singapore

  • The Aga Khan University-Kenya.

    Nairobi, 00100, Kenya

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

    Edirne, 22770, Turkey (Türkiye)

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000, Bosnia and Herzegovina

  • Wilgers Oncology Centre

    Pretoria, 0001, South Africa

More trials for these conditions

Other studies related to the condition(s) this trial covers.