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 progression - ChangHER-SC

GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)0 sites15 target enrollmentDecember 21, 2012

ConditionsPatients 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]

DrugsHerceptin®

Overview

Phase: Phase 1
Intervention: Not specified
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.
Sponsor: GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)
Enrollment: 15
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 21, 2012

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)

Eligibility 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) \<2\.
•6\. Adequate bone marrow function, liver and kidney, as follows:

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.