Breast Cancer Clinical Trial

A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer

Summary

This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC) administration in combination with chemotherapy in patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer in the neoadjuvant/adjuvant setting.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Ability to comply with the study protocol, in the investigator's judgment
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
Female and male patients with Stage II - IIIC (T2-T4 plus any N, or any T plus N1-N3, M0), locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
Primary tumor >2 cm in diameter, or node-positive disease (clinically or on imaging, and node positivity confirmed with cytology and/or histopathology)
HER2-positive breast cancer confirmed by a central laboratory prior to study enrollment. HER2-positive status will be determined based on pretreatment breast biopsy material.
Hormone receptor status of the primary tumor, centrally confirmed
Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant therapy
Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for central confirmation of HER2 and hormone receptor status and additional biomarker research
Baseline left ventricular ejection fraction (LVEF) ≥55% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
For women of childbearing potential (WOCBP) who are sexually active: agreement to remain abstinent or use one highly effective non-hormonal contraceptive method with a failure rate of <1% per year, or two effective non-hormonal contraceptive methods during the treatment period and for 7 months after the last dose of HER2-targeted therapy, and agreement to refrain from donating eggs during this same period
For men: men must remain abstinent or use a condom with a spermicidal product during the treatment period and for 7 months after the last dose of HER2-targeted therapy to avoid exposing the embryo. Men must refrain from donating sperm during this same period.
A negative serum pregnancy test must be available prior to randomization for WOCBP, unless they have undergone surgical sterilization
No major surgical procedure unrelated to breast cancer within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment

Exclusion Criteria:

Stage IV (metastatic) breast cancer
Patients with a history of invasive breast cancer
Patients with a 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
Patients who have received any previous systemic therapy for treatment or prevention of breast cancer, or radiation therapy for treatment of cancer
Patients who have a past history of ductal carcinoma in situ or lobular carcinoma in situ if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast
Patients with high-risk for breast cancer who have received chemo-preventative drugs in the past are not allowed to enter the study
Patients with multicentric breast cancer, unless all tumors are HER2-positive
Patients with bilateral breast cancer
Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph nodes
Axillary lymph node dissection prior to initiation of neoadjuvant therapy
Sentinel lymph node biopsy prior to neoadjuvant therapy
Treatment with any investigational drug within 28 days prior to randomization
Serious cardiac illness or medical conditions
Inadequate bone marrow function, renal function or impaired liver function
Current severe, uncontrolled systemic disease that may interfere with planned treatment
Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the last dose of HER2-targeted therapy
Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
Known active liver disease, for example, active viral hepatitis infection, autoimmune hepatic disorders, or sclerosing cholangitis
Concurrent, serious, uncontrolled infections, or known infection with HIV
Known hypersensitivity to study drugs, excipients, and/or murine proteins
Current chronic daily treatment with corticosteroids
History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, colon, skin, and/or non-melanoma skin carcinoma
History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such as structural heart disease, coronary heart disease, clinically significant electrolyte abnormalities, or family history of sudden unexplained death or long QT syndrome

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT03493854

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 106 Locations for this study

See Locations Near You

Maryland Oncology Hematology
Rockville Maryland, 20850, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
Levine Cancer Institute
Charlotte North Carolina, 28204, United States
Northwest Medical Specialties
Lakewood Washington, 98499, United States
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires , C1125, Argentina
Centro Oncologico Riojano Integral (CORI)
La Rioja , F5300, Argentina
COIBA
Provincia De Buenos Aires , B1884, Argentina
Institut Jules Bordet
Anderlecht , 1070, Belgium
GHdC Site Notre Dame
Charleroi , 6000, Belgium
UZ Antwerpen
Edegem , 2650, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt , 3500, Belgium
UZ Leuven Gasthuisberg
Leuven , 3000, Belgium
Clinique Ste-Elisabeth
Namur , 5000, Belgium
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania GO, 74605, Brazil
Hospital Nossa Senhora da Conceicao
Porto Alegre RS, 91350, Brazil
Hospital Perola Byington
Sao Paulo SP, 01317, Brazil
Royal Victoria Hospital
Barrie Ontario, L4M 6, Canada
Lakeridge Health Center; R. S. MacLaughlin Durham Regional Cancer Center
Oshawa Ontario, L1G 2, Canada
The Ottawa Hospital Cancer Centre
Ottawa Ontario, K2H 6, Canada
Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Centre Hospitalier Universitaire de Sherbrooke - Hopital Fleurimont
Sherbrooke Quebec, J1H 5, Canada
Masarykuv onkologicky ustav
Brno , 656 5, Czechia
Multiscan s.r.o.
Pardubice , 532 0, Czechia
ICO Paul Papin; Oncologie Medicale.
Angers , 49055, France
Institut Sainte Catherine
Avignon , 84082, France
CHRU Besançon
Besançon , 25030, France
Institut Bergonie; Oncologie
Bordeaux , 33076, France
Centre Léon Bérard
Lyon , 69373, France
Institut Curie; Oncologie Medicale
Paris , 75231, France
APHP - Hospital Saint Louis
Paris , 75475, France
ICO - Site René Gauducheau
Saint Herblain , 44805, France
Klinikum Augsburg; Frauenklinik
Augsburg , 86156, Germany
Hochwaldkrankenhaus; Abt.Gynäkologie Geburtshilfe u.Senologie
Bad Nauheim , 61231, Germany
Onkologische Schwerpunktpraxis Kurfürstendamm
Berlin , 10707, Germany
St. Johannes-Hospital
Dortmund , 44137, Germany
Klinikum Essen-Mitte Ev. Huyssens-Stiftung / Knappschafts GmbH; Klinik für Senologie / Brustzentrum
Essen , 45136, Germany
Kooperatives Mammazentrum Hamburg Krankenhaus Jerusalem
Hamburg , 20357, Germany
Sana Klinikum Offenbach GmbH; Klinik für Gynäkologie & Geburtshilfe
Offenbach , 63069, Germany
Gynäkologie Kompetenzzentrum; Praxis Dr. med. Carsten Hielscher
Stralsund , 18439, Germany
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE;U.O.C. Oncologia Medica Senologica
Napoli Campania, 80131, Italy
Università degli Studi Federico II; Clinica di Oncologia Medica
Napoli Campania, 80131, Italy
Irccs Centro Di Riferimento Oncologico (CRO); Dipartimento Di Oncologia Medica
Aviano Friuli-Venezia Giulia, 33081, Italy
Uni Degli Studi Di Genova ; Clinica Di Medicina Interna Ad Indirizzo Oncologico
Genova Liguria, 16132, Italy
ASST DI LECCO; Oncologia Medica
Lecco Lombardia, 23900, Italy
IOV - Istituto Oncologico Veneto - IRCCS; Oncologia Medica II
Padova Veneto, 35128, Italy
National Hospital Organization Kyushu Cancer Center
Fukuoka , 811-1, Japan
Fukushima Medical University Hospital
Fukushima , 960-1, Japan
Gifu University Hospital
Gifu , 501-1, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima , 730-8, Japan
Hiroshima University Hospital
Hiroshima , 734-8, Japan
National Hospital Organization Hokkaido Cancer Center
Hokkaido , 003-0, Japan
Hyogo Medical University Hospital
Hyogo , 663-8, Japan
Sagara Hospital
Kagoshima , 892-0, Japan
Kanagawa Cancer Center
Kanagawa , 241-8, Japan
Tokai University Hospital
Kanagawa , 259-1, Japan
Niigata Cancer Center Hospital
Niigata , 951-8, Japan
Okayama University Hospital
Okayama , 700-8, Japan
Osaka International Cancer Institute
Osaka , 541-8, Japan
Saitama Medical University International Medical Center
Saitama , 350-1, Japan
St. Luke's International Hospital
Tokyo , 104-8, Japan
The Cancer Institute Hospital of JFCR
Tokyo , 135-8, Japan
Seoul National University Bundang Hospital
Seongnam-si , 13605, Korea, Republic of
Seoul National University Hospital
Seoul , 03080, Korea, Republic of
Asan Medical Center
Seoul , 05505, Korea, Republic of
Ulsan University Hosiptal
Ulsan , 44033, Korea, Republic of
Centro Médico Zambrano Hellion
Monterrey Nuevo LEON, 66278, Mexico
Oncologico Potosino
San Luis Potosí SAN LUIS Potosi, 78209, Mexico
Iem-Fucam
D.f. , 04980, Mexico
Bialostockie Centrum Onkologii im. Marii Sklodowskiej - Curie
Bialystok , 15-02, Poland
Narodowy Inst.Onkol.im.Sklodowskiej-Curie Panstw.Inst.Bad Gliwice; Centr.Diagn.i Lecz.Chor.Piersi
Gliwice , 44-10, Poland
Szpital Uniwersytecki w Krakowie; Oddzial Kliniczny Onkologii i Poradnia Onkologiczna
Kraków , 31-50, Poland
Zachodniopomorskie Centrum Onkologii, Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin , 71-73, Poland
Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad; Klinika Nowtw.Piersi i Chir.Rekonstr
Warszawa , 02-78, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw , 53-43, Poland
Arkhangelsk Regional Clinical Oncology Dispensary
Arkhangelsk Arhangelsk, 16304, Russian Federation
Moscow City Oncology Hospital #62
Moscovskaya Oblast Moskovskaja Oblast, 14342, Russian Federation
Ivanovo Regional Oncology Dispensary
Ivanovo , 15304, Russian Federation
Clinical Oncology Dispensary of Ministry of Health of Tatarstan
Kazan , 42002, Russian Federation
Omsk Region Clinical Oncology Dispensary; 1St Sergical Department
Omsk , 64401, Russian Federation
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
Saint-Petersburg , 19775, Russian Federation
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
Santiago de Compostela LA Coruña, 15706, Spain
Hospital de Cruces; Servicio de Oncología Médica
Barakaldo Vizcaya, 48903, Spain
Hospital del Mar; Servicio de Oncologia
Barcelona , 08003, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona , 08908, Spain
Hospital Universitario La Princesa
Madrid , 28006, Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia
Madrid , 28041, Spain
Hospital Universitario Virgen del Rocio; Servicio de Oncologia
Sevilla , 41013, Spain
Hospital Clinico Universitario de Valencia; Servicio de Onco-hematologia
Valencia , 46010, Spain
China Medical University Hospital; Surgery
Taichung , 404, Taiwan
VETERANS GENERAL HOSPITAL; Department of General Surgery
Taipei , 00112, Taiwan
Chang Gung Medical Foundation - Linkou; Dept of Surgery
Taoyuan , 333, Taiwan
Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
Bangkok , 10700, Thailand
Maharaj Nakorn Chiang Mai Hospital; Department of Surgery/Head Neck and Breast Unit; Clinical Trial
Chiang Mai , 50200, Thailand
Songklanagarind Hospital; Department of Surgery
Songkla , 90110, Thailand
Municipal Noncommercial Institution Regional Center of Oncology
Kharkiv Kharkiv Governorate, 61070, Ukraine
Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipropetrovsk , 49102, Ukraine
National Cancer Institute MOH of Ukraine
Kiev , 36022, Ukraine
Lviv State Oncology Regional Treatment and Diagnostic Centre
Lviv , 79031, Ukraine
RCI Sumy Regional Clinical Oncological Dispensary
Sumy , 40005, Ukraine
Brighton and Sussex Univ Hosp
Brighton , BN2 5, United Kingdom
Velindre Cancer Centre
Cardiff , CF14 , United Kingdom
St Georges University Hospitals NHS Foundation Trust
London , SW17 , United Kingdom
Christie Hospital NHS Trust
Manchester , M20 4, United Kingdom
Freeman Hospital
Newcastle upon Tyne , NE7 7, United Kingdom
Nottingham City Hospital
Nottingham , NG5 1, United Kingdom
Peterborough City Hospital
Peterborough , PE3 9, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

500

Study ID:

NCT03493854

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.