Recruitment

Recruitment Status
Completed

Inclusion Criteria

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

Exclusion Criteria

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
Pregnant or lactating women
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
...
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
Pregnant or lactating women
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
Inadequate hepatic or renal function
Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
Participants with 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, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
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
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

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 Criteria

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

Exclusion Criteria

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
Pregnant or lactating women
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
...
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
Pregnant or lactating women
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
Inadequate hepatic or renal function
Participants with other concurrent serious diseases that might interfere with planned treatment, including severe pulmonary conditions/illness
Participants with 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, high-risk uncontrolled arrhythmias, angina pectoris requiring medication, clinically significant valvular disease, evidence of transmural infarction on electrocardiogram (ECG), poorly controlled hypertension
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
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

Locations

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

Tracking Information

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