Breast Cancer Clinical Trial

A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer

Summary

This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant treatment in participants with HER2-positive locally advanced, inflammatory, or early-stage breast cancer. Each investigator will choose a treatment regimen (A or B) for all of their participants to follow. Treatment regimen A (for Cohort A) will include dose-dense doxorubicin and cyclophosphamide (ddAC), followed by paclitaxel, with pertuzumab and trastuzumab given from the start of paclitaxel. Treatment regimen B (for Cohort B) will include 5-fluorouracil, epirubicin, and cyclophosphamide (FEC), followed by docetaxel, with pertuzumab and trastuzumab given from the start of docetaxel. Participants in both cohorts will subsequently undergo surgical treatment and then resume pertuzumab and trastuzumab treatment.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Male and female participants with locally advanced, inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer. Participants with inflammatory breast cancer must be able to have a core needle biopsy
Primary tumor greater than (>) 2 centimeters (cm) in diameter, or > 5 millimeters (mm) in diameter and node-positive
HER2-positive breast cancer confirmed by a central laboratory
Availability of tumor tissue specimen
Baseline LVEF greater than or equal to (>/=) 55%
Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to ( At least 4 weeks since major unrelated surgery, with full recovery
Women of childbearing potential and male participants with partners of childbearing potential must agree to use a "highly effective" non-hormonal form of contraception or two "effective" forms of non-hormonal contraception by the patient and/or partner. Contraception must continue for the duration of study treatment and for at least 7 months after the last dose of study treatment

Exclusion Criteria:

Metastatic disease (Stage IV) or bilateral breast cancer
Participants who have had an incisional biopsy of the primary tumor or the primary tumor excised
Prior breast or non-breast malignancy within 5 years prior to study entry, except for carcinoma in situ and basal cell and squamous cell carcinoma of the skin. Participants with malignancies occurring more than 5 years prior to study entry are permitted if curatively treated
Any previous systemic therapy (including chemotherapy, immunotherapy, HER2 targeted agents, and antitumor vaccines) for cancer, or radiation therapy for cancer
Participants with a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) are not allowed to enter the study if they have received any systemic therapy for its treatment or radiation therapy to the ipsilateral breast (they are allowed to enter the study if treated with surgery alone)
High-risk participants who have received chemopreventive drugs in the past are not allowed to enter the study
Inadequate bone marrow, renal, or liver function
History or evidence of cardiovascular condition
Dyspnea at rest or other diseases that require continuous oxygen therapy
Severe, uncontrolled systemic disease
Participants with poorly controlled diabetes or with evidence of clinically significant diabetic vascular complications
Pregnancy or breast-feeding women
Participants who received any investigational treatment within 4 weeks of study start
Participants with known infection with human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus
Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone or equivalent [excluding inhaled steroids])
Known hypersensitivity to any of the study drugs or excipients

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

401

Study ID:

NCT02132949

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 80 Locations for this study

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University of South Alabama; Mitchell Cancer Institute
Mobile Alabama, 36604, United States
Marin Specialty Care
Greenbrae California, 94904, United States
California Pacific Medical Center
San Francisco California, 94115, United States
MedStar Georgetown University Hospital (Lombardi Comprehensive Cancer Center)
Washington District of Columbia, 20007, United States
Washington Cancer Institute at MedStar Washington Hospital Center.
Washington District of Columbia, 20010, United States
Cancer Specialists; North Florida ;Jacksonville (AC Skinner Pkwy)
Jacksonville Florida, 32256, United States
Northwest Georgia Oncology Centers PC - Marietta
Marietta Georgia, 30060, United States
Berkshire Medical Center
Pittsfield Massachusetts, 01201, United States
Allina Health, Virginia Piper Cancer Institute
Minneapolis Minnesota, 55407, United States
Saint Lukes Hospital Cancer Institute
Kansas City Missouri, 64111, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Regional Cancer Care Associates LLC - Morristown
Morristown New Jersey, 07962, United States
San Juan Oncology Associates
Farmington New Mexico, 87401, United States
MSKCC @ Commack
Commack New York, 11725, United States
MSKCC @ West Harrison
Harrison New York, 10604, United States
Mount Sinai Beth Israel Comprehensive Cancer Center
New York New York, 10011, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
MSKC @ Rockville
Rockville Centre New York, 11570, United States
Mercy Clinic Oklahoma Communties, Inc
Oklahoma City Oklahoma, 73120, United States
Harrington Cancer Center
Amarillo Texas, 79106, United States
University of Utah; Huntsman Cancer Hospital
Salt Lake City Utah, 84112, United States
Blue Ridge Cancer Care
Roanoke Virginia, 24014, United States
PeaceHealth St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Northwest Medical Specialties
Tacoma Washington, 98405, United States
Horizon Health Network
Moncton New Brunswick, E1C 6, Canada
Royal Victoria Hospital
Barrie Ontario, L4M 6, Canada
Cite de La Sante de Laval; Hemato-Oncologie
Laval Quebec, H7M 3, Canada
St Mary's Hospital Center
Montreal Quebec, H3T1M, Canada
Hopital Sacre-Coeur Research Centre
Montreal Quebec, H4J 1, Canada
Allan Blair Cancer Centre
Regina Saskatchewan, S4T 7, Canada
Herlev Hospital; Afdeling for Kræftbehandling
Herlev , 2730, Denmark
Rigshospitalet; Onkologisk Klinik
København Ø , 2100, Denmark
Vejle Sygehus; Onkologisk Afdeling
Vejle , 7100, Denmark
Clinique Victor Hugo; Chimiotherapie
Le Mans , 72015, France
Centre Oscar Lambret; Cancerologie Gynecologique
Lille , 59020, France
Centre Leon Berard; Departement Oncologie Medicale
Lyon , 69373, France
Clinique Clementville; Hopital De Jour
Montpellier , 34070, France
Centre D'Oncologie de Gentilly; Oncology
Nancy , 54100, France
Centre Antoine Lacassagne; Hopital De Jour A2
Nice , 06189, France
Institut Curie; Oncologie Medicale
Paris , 75231, France
Centre Eugene Marquis; Unite Huguenin
Rennes , 35042, France
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif , 94805, France
Universitätsklinikum "Carl Gustav Carus"; Frauenheilkunde und Geburtshilfe
Dresden , 01307, Germany
Dres.Andreas Ammon und Dirk Meyer
Göttingen , 37073, Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen , 63225, Germany
Klinikum rechts der Isar der TU München; Klinik und Poliklinik für Frauenheilkunde
München , 81675, Germany
Ruppiner Kliniken, Klinik fuer Gynaekologie und Geburtshilfe
Neuruppin , 16816, Germany
Policlinico Umberto i di Roma; dip. Scienze Radiologiche, Oncologiche, Anatomopatologiche
Roma Lazio, 00161, Italy
A.O. Città della Salute e della Scienza - Presidio Molinette; divisione oncologia medica
Torino Piemonte, 10126, Italy
Asl Le-Ospedale "Vito Fazzi";U.O. Oncologia
Lecce Puglia, 73100, Italy
Casa Di Cura Di Alta Specialita La Maddalena; Dept. Oncologico Di Iii Livello
Palermo Sicilia, 90146, Italy
Ospedale Santa Maria Annunziata; Oncologia
Bagno a Ripoli Toscana, 50012, Italy
Ospedale Della Misericordia; U.O. Di Medicina Ia - Oncologia Medica
Grosseto Toscana, 58100, Italy
Iem-Fucam
D.f. , 04980, Mexico
Centro de Diagnóstico y Tratamiento Integral de Mama, Hospital San José Tec de Monterrey
Monterrey , 64710, Mexico
Haukeland Universitetssjukehus; Klinisk forskningspost
Bergen , 5021, Norway
Oslo universitetssykehus HF, Ullevål, Kreftsenteret
Oslo , 0450, Norway
Bialostockie Centrum Onkologii; Oddzial Onkologii Klinicznej
Bialystok , 15-02, Poland
Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
Kraków , 30-68, Poland
Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina, Klinika Onkologii
Otwock , 05-40, Poland
Wielkopolskie Centrum Onkologii; im. Marii Skłodowskiej-Curie
Poznan , 61-86, Poland
Centro Clinico Champalimaud; Oncologia Medica
Lisboa , 1400-, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisboa , 1649-, Portugal
Hospital Beatriz Angelo; Departamento de Oncologia
Loures , 2674-, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto , 4200-, Portugal
Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia
Badalona Barcelona, 08916, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba Cordoba, 14004, Spain
Centro Oncológico Gallego José Antonio Quiroga y Piñeiro, Servicio de Oncologia
La Coruña , 15009, Spain
Hospital Universitario de la Princesa; Servicio de Oncologia
Madrid , 28006, Spain
Hospital Ramon y Cajal; Servicio de Oncologia
Madrid , 28034, Spain
Hospital Universitario Virgen Macarena; Servicio de Oncologia
Sevilla , 41009, Spain
Complejo Hospitalario de Toledo- H. Virgen de la Salud; Servicio de Oncologia
Toledo , 45004, Spain
Royal United Hospital; Oncology Department
Bath , BA1 3, United Kingdom
Royal Bournemouth Hospital; Oncology
Bournemouth , BH7 7, United Kingdom
Guys & St Thomas Hospital; Department of Oncology
London , SE1 9, United Kingdom
Royal Marsden Hospital - Fulham; Oncology Department
London , SW3 6, United Kingdom
Freeman Hospital; Northern Centre For Cancer Care
New Castle Upon Tyne , NE7 7, United Kingdom
Churchill Hospital; Oxford Cancer and Haematology Centre
Oxford , OX3 7, United Kingdom
Peterborough City Hospital, Edith Cavell Campus; Oncology Department
Peterborough , PE3 9, United Kingdom
Royal Marsden Hospital; Dept of Medical Oncology
Sutton , SM2 5, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

401

Study ID:

NCT02132949

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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