Phase
Condition
Breast Cancer
Treatment
Trastuzumab Emtansine
Pertuzumab IV
Trastuzumab IV
Clinical Study ID
Ages > 18 All Genders
Study Summary
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
Connect with a study center
Fundación CENIT para la Investigación en Neurociencias
Buenos Aires, C1125ABD
ArgentinaSite Not Available
Centro Oncologico Korben
Ciudad Autonoma Buenos Aires, C1426AGE
ArgentinaSite Not Available
Centro Oncologico Korben; Oncology
Ciudad Autonoma Buenos Aires, C1426AGE
ArgentinaSite Not Available
University Clinical Center of the Republic of Srpska
Banja Luka, 78000
Bosnia and HerzegovinaSite Not Available
Cantonal Hospital Zenica
Zenica, 72000
Bosnia and HerzegovinaSite Not Available
Cantonal Hospital Zenica; Department for Oncology
Zenica, 72000
Bosnia and HerzegovinaSite Not Available
Crio - Centro Regional Integrado de Oncologia
Fortaleza, Ceará 60336-550
BrazilSite Not Available
Hospital Araujo Jorge; Departamento de Ginecologia E Mama
Goiania, GO 74605-070
BrazilSite Not Available
Hospital Araujo Jorge
Goiania, Goiás 74605-070
BrazilSite Not Available
Hospital Moinhos de Vento
Porto Alegre, RS 90035-000
BrazilSite Not Available
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande Do Sul 91350-200
BrazilSite Not Available
Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda
Sao Paulo, São Paulo 01317-001
BrazilSite Not Available
Multiprofile Hospital for Active Treatment Uni Hospital
Panagyurishte, 4500
BulgariaSite Not Available
Multiprofile Hospital for Active Treatment Uni Hospital; Department of medicinal oncology
Panagyurishte, 4500
BulgariaSite Not Available
UMHAT Dr Georgi Stranski; Medical Oncology Department
Pleven, 5800
BulgariaSite Not Available
University Multiprofile Hospital for Active Treatment Sveta Marina Pleven OOD
Pleven, 5800
BulgariaSite Not Available
Complex Oncology Center - Plovdiv First Internal Chemotherapy Department
Plovdiv, 4004
BulgariaSite Not Available
DDODIU-Plovdiv, EOOD; Third Internal Department
Plovdiv, 4004
BulgariaSite Not Available
MHAT Nadezhda
Sofia, 1330
BulgariaSite Not Available
Royal Victoria Regional Health Centre
Barrie, Ontario L4M 6M2
CanadaSite Not Available
Lakeridge Health Oshawa
Oshawa, Ontario L1G 2B9
CanadaSite Not Available
North York General Hospital
Toronto, Ontario M2K 1E1
CanadaSite Not Available
Jewish General Hospital
Montreal, Quebec H3T 1E2
CanadaSite Not Available
Hopital du Saint Sacrement
Quebec City, Quebec G1S 4L8
CanadaSite Not Available
Centro de Estudios Clínicos SAGA
Santiago,
ChileSite Not Available
Clinica Vespucio
Santiago, 8241479
ChileSite Not Available
Hospital Metropolitano (Sede Lindora-Santa Ana)
San Jose, 10903
Costa RicaSite Not Available
Hospital Metropolitano (Sede Lindora-Santa Ana); Centro de Cancer
San Jose, 10903
Costa RicaSite Not Available
Clinica CIMCA
San José, 10103
Costa RicaSite Not Available
ICIMED Instituto de Investigación en Ciencias Médicas
San José, 10108
Costa RicaSite Not Available
Clinical Hospital Centre Zagreb
Zagreb, 10000
CroatiaSite Not Available
Max Institute of Cancer Care
NEW Delhi Delhi, Delhi 110024
IndiaSite Not Available
Saifee Hospital
Mumbai, Maharashtra 400004
IndiaSite Not Available
TATA Medical Centre
Kolkata, WEST Bengal 700156
IndiaSite Not Available
TATA Medical Centre; Medical Oncology
Kolkata, WEST Bengal 700156
IndiaSite Not Available
International Cancer Institute (ICI)
Eldoret, 30100
KenyaSite Not Available
Aga Khan University Hospital
Nairobi, 00100
KenyaSite Not Available
Korea University Anam Hospital
Seoul, 02841
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Health Pharma Professional Research
Cdmx, Mexico CITY 03100
MexicoSite Not Available
Iem-Fucam
D.f., Mexico CITY 04980
MexicoSite Not Available
Oncologico Potosino
San Luis Potosí, SAN LUIS Potosi 78209
MexicoSite Not Available
Instituto Regional de Enfermedades Neoplásicas del Sur
Arequipa, 5154
PeruSite Not Available
Instituto Regional de Enfermedades Neoplásicas del Sur; Centro de Inv. de Medicina Oncológica
Arequipa, 5154
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplasicas
Lima, Lima 34
PeruSite Not Available
Oncocenter Peru S.A.C.
Lima, Lima 41
PeruSite Not Available
Oncocenter Peru S.A.C.; Oncosalud
Lima, Lima 41
PeruSite Not Available
Instituto Regional de Enfermedades Neoplasicas - IREN Norte
Trujillo, 13014
PeruSite Not Available
National Cancer Centre
Singapore, 168583
SingaporeSite Not Available
National Cancer Centre; Medical Oncology
Singapore, 168583
SingaporeSite Not Available
National University Hospital; National University Cancer Institute, Singapore (NCIS)
Singapore, 119228
SingaporeSite Not Available
Tan Tock Seng Hospital
Singapore, 308433
SingaporeSite Not Available
Tan Tock Seng Hospital; Oncology
Singapore, 308433
SingaporeSite Not Available
Medical Oncology Centre of Rosebank
Johannesburg, 2196
South AfricaSite Not Available
Medical Oncology Centre of Rosebank; Oncology
Johannesburg, 2196
South AfricaSite Not Available
University of Pretoria Oncology Department; Medical Oncology
Pretoria, 0002
South AfricaSite Not Available
Wilgers Oncology Centre
Pretoria, 0001
South AfricaSite Not Available
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico
Jaen, 23007
SpainSite Not Available
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaen, 23007
SpainSite Not Available
Hospital Universitario Virgen de Arrixaca
Murcia, 30120
SpainSite Not Available
Hospital Universitario Virgen de Arrixaca; Servicio de Oncologia
Murcia, 30120
SpainSite Not Available
Hospital Clinico Universitario de Salamanca
Salamanca, 37007
SpainSite Not Available
Hospital Clinico Universitario de Salamanca; Servicio de Oncologia
Salamanca, 37007
SpainSite Not Available
Ankara City Hospital
Ankara, 06800
TurkeySite Not Available
Ankara City Hospital; Oncology
Ankara, 06800
TurkeySite Not Available
Gulhane Training and Research Hospital
Ankara, 06010
TurkeySite Not Available
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
Edirne, 22770
TurkeySite Not Available
Ba?c?lar Medipol Mega Üniversite Hastanesi
Istanbul, 34214
TurkeySite Not Available
Ba?c?lar Medipol Mega Üniversite Hastanesi; Oncology
Istanbul, 34214
TurkeySite Not Available
Hacettepe Uni Medical Faculty Hospital
Sihhiye/Ankara, 06230
TurkeySite Not Available
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
Sihhiye/Ankara, 06230
TurkeySite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.