Recruitment

Recruitment Status
Completed

Inclusion Criterias

Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
Use of concurrent radiotherapy will be permitted
Hormonal therapy will be allowed as per institutional guidelines
...
Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
Use of concurrent radiotherapy will be permitted
Hormonal therapy will be allowed as per institutional guidelines
HER2-positive disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
Prior use of anti-HER2 therapy will be allowed
Completion of surgery and chemotherapy (if applicable)

Exclusion Criterias

Inadequate hepatic or renal function
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 who have been disease-free for the last 5 years
Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
...
Inadequate hepatic or renal function
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 who have been disease-free for the last 5 years
Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
Pregnant or lactating women
Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma

Summary

Conditions
Breast Cancer
Type
Interventional
Phase
Phase 3
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

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

Inclusion Criterias

Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
Use of concurrent radiotherapy will be permitted
Hormonal therapy will be allowed as per institutional guidelines
...
Left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 50 percent (%)
Use of concurrent radiotherapy will be permitted
Hormonal therapy will be allowed as per institutional guidelines
HER2-positive disease
Eastern Cooperative Oncology Group (ECOG) performance status 0-1
No evidence of residual, locally recurrent or metastatic disease after completion of surgery and chemotherapy, or during concurrent chemotherapy (neo-adjuvant or adjuvant)
Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
Prior use of anti-HER2 therapy will be allowed
Completion of surgery and chemotherapy (if applicable)

Exclusion Criterias

Inadequate hepatic or renal function
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 who have been disease-free for the last 5 years
Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
...
Inadequate hepatic or renal function
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 who have been disease-free for the last 5 years
Concurrent enrollment in another clinical trial using an investigational anti-cancer treatment, including hormonal therapy, biphosphonate therapy and immunotherapy, within 28 days prior to the first dose of study treatment
Women of childbearing potential and male participants with female partners of childbearing potential who are unable or unwilling to use adequate contraceptive methods during study treatment
Serious cardiac illness or medical conditions that would preclude the use of trastuzumab, specifically: history of documented congestive heart failure, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
Pregnant or lactating women
Participants with severe dyspnea at rest or requiring supplementary oxygen therapy
Known hypersensitivity to trastuzumab, murine proteins, to any excipients of Herceptin, including hyaluronidase, or the adhesive of the SC device, or a history of severe allergic or immunological reactions, e.g. difficult to control asthma

Locations

EDE, 6716 RP
Alkmaar, 1815 JD
Nieuwegein, 3430 EM
Hengelo, 7555 DL
Breda, 4819 EV
...
EDE, 6716 RP
Alkmaar, 1815 JD
Nieuwegein, 3430 EM
Hengelo, 7555 DL
Breda, 4819 EV
Groningen, 9728 MG
Venlo, 5912 BL
Delft, 2600 GA
Roosendaal, 4708 AE
Capelle Aan De Yssel, 2906 ZC
Hoofddorp, 2134 TM
Den Haag, 2504 LN
Hilversum, 1213 HX
Haarlem, 2035 RC
Sittard-Geleen, 6162 BG
Zwolle, 8011 JW
Amersfoort, 3818 ES

Tracking Information

NCT #
NCT02040935
Collaborators
Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche