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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Brest Cancer

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Trial Information

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


Inclusion Criteria:



- Woman, 18 years old or upper.

- 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.

- 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 Criteria:

- Patients with no advanced breast cancer.

- Breast cancer patients with tumors HER2-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 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.

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Percentage of treatment preference

Outcome Description:

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 the questionnaire of experiences and preferences of the patient)

Outcome Time Frame:

6 months after the date on which the last patient receives the fourth cycle of study

Safety Issue:

No

Principal Investigator

Ana M. Casas Fernández de Tejerina, MD

Investigator Role:

Study Director

Investigator Affiliation:

Hospital Universitario Virgen del Rocío

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM/2012-07

NCT ID:

NCT01875367

Start Date:

June 2013

Completion Date:

May 2016

Related Keywords:

  • Brest Cancer
  • Subcutaneous trastuzumab
  • Intravenous trastuzumab
  • HER2 positive
  • Advanced Breast Cancer
  • Breast Neoplasms

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