Recruitment

Recruitment Status
Completed

Inclusion Criterias

Intact skin at site of SC injection on the thigh
Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. Stage of disease: T1-4 (T describes size of tumour from 1 to 4), N0-3 (N describes nearby lymph nodes), M0 (M describes distant metastasis)
HER2-positive disease immunohistochemistry (IHC) 3+ or in situ hybridization (ISH) positive
...
Intact skin at site of SC injection on the thigh
Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. Stage of disease: T1-4 (T describes size of tumour from 1 to 4), N0-3 (N describes nearby lymph nodes), M0 (M describes distant metastasis)
HER2-positive disease immunohistochemistry (IHC) 3+ or in situ hybridization (ISH) positive
Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC
Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criterias

Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device (for Cohort B), or a history of severe allergic or immunological reactions, for example, difficulty to control asthma
Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Hormonal treatment concomitant with chemotherapy (allowed in adjuvant phase with adjuvant trastuzumab SC)
...
Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device (for Cohort B), or a history of severe allergic or immunological reactions, for example, difficulty to control asthma
Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Hormonal treatment concomitant with chemotherapy (allowed in adjuvant phase with adjuvant trastuzumab SC)
Concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
Severe dyspnea at rest or requiring supplementary oxygen therapy
Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
Inadequate bone marrow, hepatic or renal function
Pregnant or lactating women
Synchronous bilateral invasive breast cancer
Pre-existing motor or sensory neuropathy of Grade greater than (>) 1

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Non-Randomized
  • Intervention Model: Sequential Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Inclusion Criterias

Intact skin at site of SC injection on the thigh
Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. Stage of disease: T1-4 (T describes size of tumour from 1 to 4), N0-3 (N describes nearby lymph nodes), M0 (M describes distant metastasis)
HER2-positive disease immunohistochemistry (IHC) 3+ or in situ hybridization (ISH) positive
...
Intact skin at site of SC injection on the thigh
Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast. Stage of disease: T1-4 (T describes size of tumour from 1 to 4), N0-3 (N describes nearby lymph nodes), M0 (M describes distant metastasis)
HER2-positive disease immunohistochemistry (IHC) 3+ or in situ hybridization (ISH) positive
Left ventricular ejection fraction (LVEF) of greater than or equal to (>=) 55 percent (%) measured by echocardiography (ECHO) or multiple gated acquisition (MUGA) scan prior to first dose of trastuzumab SC
Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criterias

Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device (for Cohort B), or a history of severe allergic or immunological reactions, for example, difficulty to control asthma
Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Hormonal treatment concomitant with chemotherapy (allowed in adjuvant phase with adjuvant trastuzumab SC)
...
Known hypersensitivity to trastuzumab, murine proteins, to any of the excipients of Herceptin including hyaluronidase, or the adhesive of the SC device (for Cohort B), or a history of severe allergic or immunological reactions, for example, difficulty to control asthma
Concurrent enrolment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, bisphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Hormonal treatment concomitant with chemotherapy (allowed in adjuvant phase with adjuvant trastuzumab SC)
Concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness
Known infection with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV)
History of other malignancy, except for participants with curatively treated carcinoma in situ of the cervix or basal cell carcinoma and participants with other curatively treated malignancies, other than breast cancer, who have been disease-free for at least 5 years
Severe dyspnea at rest or requiring supplementary oxygen therapy
Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure (CHF), high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), diagnosed poorly controlled hypertension
Inadequate bone marrow, hepatic or renal function
Pregnant or lactating women
Synchronous bilateral invasive breast cancer
Pre-existing motor or sensory neuropathy of Grade greater than (>) 1

Locations

Vicenza, Veneto, 36100
Varese, Lombardia, 21100
Torino, Piemonte, 10128
Brescia, Lombardia, 25123
Firenze, Toscana, 50139
...
Vicenza, Veneto, 36100
Varese, Lombardia, 21100
Torino, Piemonte, 10128
Brescia, Lombardia, 25123
Firenze, Toscana, 50139
Roma, Lazio, 00186
Milano, Lombardia, 20141
Sant'Andrea Delle Fratte (PG), Umbria, 06132
Roma, Lazio, 00168
Treviso, Veneto, 31100
Pavia, Lombardia, 27100
Treviglio, Lombardia, 24047
Brescia, Lombardia, 25124
Milano, Lombardia, 20132
Frattamaggiore, Campania, 80027
Catania, Sicilia, 95126
Genova, Liguria, 16132
Roma, Lazio, 00168
Genova, Liguria, 16132
Castelfranco Veneto, Veneto, 31033
L'aquila, Abruzzo, 67010
Candiolo, Piemonte, 10060
Aviano, Friuli-Venezia Giulia, 33081
Livorno, Toscana, 57100
La Spezia, Liguria, 19125
Reggio Emilia, Emilia-Romagna, 42100
Macerata, Marche, 62100
Avellino, Campania, 83100
Asti, Piemonte, 14100
Arezzo, Toscana, 52100
Ancona, Marche, 60121
Reggio Calabria, Calabria, 89100
Mestre, Veneto, 30174
Udine, Friuli-Venezia Giulia, 33100
Roma, Lazio, 00189
Saronno, Lombardia, 21047
Carpi, Emilia-Romagna, 41012
Napoli, Campania, 80131
Bologna, Emilia-Romagna, 40138
Grosseto, Toscana, 58100
Catanzaro, Calabria, 88100
Negrar, Veneto, 37024
Pesaro, Marche, 61122
Como, Lombardia, 22100
Lecco, Lombardia, 23900
Bologna, Emilia-Romagna, 40133
Mantova, Lombardia, 46100
Lido Di Camaiore, Toscana, 55043
Ponderano (BI), Piemonte, 13875
Poggibonsi, Toscana, 53036
Cuneo, Piemonte, 12100
Mirano, Veneto, 30035
Guastalla, Emilia-Romagna, 42016
Potenza, Basilicata, 85100

Tracking Information

NCT #
NCT01940497
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche