Status:
COMPLETED
Phase III to Evaluate Patient´s Preference of Subcutaneous Trastuzumab vs Intravenous in HER2+ Advanced Breast Cancer
Lead Sponsor:
Spanish Breast Cancer Research Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
GEICAM/2012-07 is a study phase III, prospective, open, randomized, multicenter and national designed to assess patient preference for intravenous (IV) or subcutaneous (SC) of trastuzumab, and within ...
Detailed Description
Approximately 195 patients will be included to receive subcutaneous trastuzumab a fixed dose of 600 mg every 3 weeks for 4 cycles (2 administered from the injection of a vial with a syringe and 2 with...
Eligibility Criteria
Inclusion
- Woman, 18 years old or upper.
- Patient with advanced breast cancer with human epidermal growth factor receptor 2 (HER 2) positive histologically confirmed. The criteria for positivity HER 2 are:
- immuno-histochemistry (IHC) 3+ (\>10% of tumor cells with complete and intense membrane staining)
- IHC 2+ with fluorescent in situ hybridization (FISH) / Chromogenic in situ hybridization (CISH) / silver-enhanced in situ hybridization (SISH) + for HER 2 amplification (\*)
- FISH / CISH / SISH + for HER 2 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.
- Patient receiving trastuzumab with or without chemotherapy or hormonal therapy for at least 4 months.
- 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.
- Adequate performance status: Eastern Cooperative Oncology Group (ECOG) \<2.
- Adequate bone marrow function, liver and kidney
- Proper cardiac function (LVEF within normal limits the center, measured by echocardiography or MUGA).
- The patient must have been informed of the study and must sign and date informed consent document for entry into the trial.
- The patient must be willing and able to comply with study procedures and be available to answer the study questionnaires.
Exclusion
- Patients with no advanced breast cancer.
- Breast cancer patients with tumors HER 2-negative.
- 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.
- The patient has uncontrolled brain metastases.
- Concomitant administration, or in the 4 weeks prior to study entry, of other experimental treatment.
- Known hypersensitivity to trastuzumab or to any of its components.
- Patients with severe dyspnea at rest or requiring supplemental oxygen.
- Heart disease or serious medical pathological prevent trastuzumab administration: documented history of congestive cardiac insufficiency (CCI), 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.
- Presence of any concomitant serious systemic disease that is incompatible with the study (at the discretion of the investigator).
- 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.
Key Trial Info
Start Date :
September 18 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2018
Estimated Enrollment :
166 Patients enrolled
Trial Details
Trial ID
NCT01875367
Start Date
September 18 2013
End Date
April 30 2018
Last Update
April 5 2023
Active Locations (27)
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1
Hospital de Manacor
Manacor, Balearic Islands, Spain, 07500
2
Hospital General Universitario de Granollers
Granollers, Barcelona, Spain, 08402
3
Hospital de Mataró
Mataró, Barcelona, Spain, 08304
4
Hospital Sant Joan Despí Moises Broggi
Sant Joan Despí, Barcelona, Spain, 08970