A phase III clinical trial to evaluate patient´s preference of subcutaneous trastuzumab (SC) versus intravenous (IV) administration in patients with HER2 positive Advanced Breast Cancer (ABC) who have received intravenous trastuzumab at least 4 months and without disease progressio

Phase 1

• Conditions: 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); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004928-38-ES
• Lead Sponsor: GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-12-21
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 15

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) <2.
6. Adequate bone marrow function, liver and kidney, as follows:
? Bone marrow: ANC ? 1500/mm3 (1.5 x 109 / l), platelets ? 100.000/mm3 (100.0 x 109 / l) and hemoglobin ? 9.0 g / dl.
? Liver function: total serum bilirubin ? 1.5 x upper limit of normal (ULN), aspartate transaminase (AST) and alanine aminotransferase (ALT) ? 2.5 × ULN or ? 5.0 x ULN if the elevated transaminases due to liver metastases, and alkaline phosphatase (ALP) ? 5.0 x ULN.
? Renal function: serum creatinine 1.5 x ULN ?.
7. Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).
8. The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.
9. The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 195

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified