Patients with HER2 positive Advanced Breast Cancer receiving trastuzumab with or without CT or HT therapy for at least four months without evidence of disease progression and a life expectancy of at least 3 months. MedDRA version: 14.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Trastuzumab para inyección subcutánea
Product Code: Ro 045-2317/F07
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TRAST
Sponsors
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 11. Woman, 18 years old or upper. 2. Patient with advanced breast cancer with HER2 positive histologically confirmed. The criteria for positivity HER2 are: - IHC 3 + - IHQ2 + with FISH / CISH / SISH positive for HER2 amplification (*) - FISH / CISH / SISH positive for HER2 amplification (*) (*) Defined as the ratio of copies of HER-2/neu and copies of centromere of chromosome 17 (CEP17)> 2.2, or a number of copies of HER-2/neu> 6, as per local laboratory criteria. 3. Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months. 4. No evidence of disease progression (clinical and / or radiological) for at least 4 months before inclusion in the study and with a life expectancy of at least 3 months. 5. Adequate performance status: Eastern Cooperative Oncology Group (ECOG) =65 years) yes F.1.3.1 Number of subjects for this age range 195
Exclusion criteria
Exclusion criteria: 1. Patients with no advanced breast cancer. 2. Breast cancer patients with tumors HER2-negative. 3. The patient has another active malignancy other than breast adenocarcinoma; are excluded the non-melanoma skin cancer or any other properly treated in situ neoplasia. Patients with a history of malignancy, if they bear> 5 years without evidence of disease could be included. 4. The patient has uncontrolled brain metastases. 5. Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment. 6. Known hypersensitivity to trastuzumab or to any of its components. 7. Patients with severe dyspnea at rest or requiring supplemental oxygen. 8. Heart disease or serious medical pathological prevent trastuzumab administration: documented history of CHF, high-risk arrhythmias uncontrolled angina requiring medication, clinically significant valvular disease, history of myocardial infarction or evidence of transmural infarction on ECG or hypertension poorly controlled. 9. Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator). 10. The patient is pregnant or lactating. Women of childbearing potential should undergo pregnancy testing blood or urine within 14 days prior to inclusion as institutional rules and use a non-hormonal contraceptive suitable: intrauterine device, barrier method (condom or diaphragm) also used in conjunction with spermicidal cream, total abstinence or surgical sterilization, during treatment with the study drugs and for 6 months following the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: - To analyze the percentage of patients who indicate a preference for the use of the vial SC administration or device administration. - To analyze the medical staff satisfaction related with the use of different methods of treatment administration. - To analyze the administration costs and indirect costs (by means of a study of time and progress) to compare the different methods of treatment administration. ? Analyze the safety and tolerability of different treatment methods of administration. ? To study the immunogenicity of trastuzumab SC (vial and device) and intravenous. ;Timepoint(s) of evaluation of this end point: 6 months after the date on which the last patient receives the fourth cycle of study treatment;Main Objective: To analyze the percentage of patients who indicate a preference for the use of the subcutaneous vs the intravenous administration of trastuzumab.;Primary end point(s): To analyze the percentage of patients who indicate a preference for the use of the intravenous vs subcutaneous administration of trastuzumab (will be analyzed with the answers to question 39 of the questionnaire of experiences and preferences of the patient) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. To analyze the percentage of patients who indicate a preference for the use of SC administration by road or device: will be discussed in the answers to question number 28 of the questionnaire of experiences and preferences of the patient. 2. To analyze medical staff satisfaction with the use of different methods of treatment administration: will be discussed in the answers to question number 33 of the questionnaire of experiences and preferences of the medical staff. 3. To analyze administration costs and indirect costs (by means of a time and progress study) of different treatment methods. This point is developed in the sub-study protocol. 4. Analyze the safety and tolerability of different treatment methods will be studied and AAGS AAs. Also take into account all premature treatment dropout due to drug toxicities. 5. To study the immunogenicity of trastuzumab SC (vial and device) and intravenous. ; Timepoint(s) of evaluation of this end point: - 6 months after the date the last patient receives the fourth cycle of study treatment (for points 1, 2, 3 and 5 Secondary) - 6 months after the date the last patient receives the fourth SC Trastuzumab treatment cycle (it has been estimated after 2 years of treatment). | — |
Countries
Spain
Contacts
Public ContactMª Angeles Jimeno Lara
GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
Outcome results
None listed