Interventions (Datenquelle: WHO)
A PLANNED TOTAL OF APPROXIMATELY 2,500 EVALUABLE PATIENTS WILL BE ENROLLED INTO THE STUDY. THE TRIAL WILL BE CONDUCTED AT APPROXIMATELY 300 CENTRES IN APPROXIMATELY 40 COUNTRIES.
ALL POTENTIAL STUDY PATIENTS MUST PROVIDE SIGNED WRITTEN INFORMED CONSENT (APPROVED BY THE RELEVANT INDEPENDENT ETHICS COMMITTEE [EC]) BEFORE UNDERGOING ANY STUDY-SPECIFIC PROCEDURE. RESULTS OF THE SCREENING ASSESSMENTS MUST BE AVAILABLE AND PATIENTS MUST MEET ALL ELIGIBILITY CRITERIA PRIOR TO ENROLMENT INTO THE STUDY.
ENROLMENT AND THE START OF STUDY MEDICATION (DENOTED AS DAY 1) OCCUR ON THE SAME DAY.
ELIGIBLE PATIENTS WILL BE ALLOCATED TO COHORT A OR B AT THE INVESTIGATORS? DISCRETION:
? COHORT A (APPROXIMATELY 1,800 PATIENTS): TRASTUZUMAB SC 600MG, ASSISTED ADMINISTRATION INTO THE THIGH OVER A PERIOD OF UP TO 5 MINUTES, USING CONVENTIONAL HANDHELD SYRINGES WITH HYPODERMIC NEEDLES;
COHORT B (APPROXIMATELY 700 PATIENTS): TRASTUZUMAB SC 600MG, FIRST ASSISTED-, THEN SELF-ADMINISTERED INTO THE THIGH OVER A PERIOD OF UP TO 5 MINUTES, USING THE SID. FOR ENROLMENT INTO COHORT B, PATIENTS NEED TO BE WILLING TO SELF-ADMINISTER THE STUDY DRUG BASED ON THE INSTRUCTIONS FOR USE SUPPLIED WITH THE SID AND PERSONAL INSTRUCTIONS PROVIDED BY AN HCP DURING THE FIRST ASSISTED ADMINISTRATION.
Inclusion/Exclusion Criteria
(Datenquelle: WHO)
Gender: --
Maximum age: 99
Minimum age: 18
Inclusion criteria:
1. SIGNED WRITTEN INFORMED CONSENT APPROVED BY THE REVIEWING INDEPENDENT ETHICS COMMITTEE (EC)
2. FEMALE OR MALE AGED 18 YEARS OR ABOVE
3. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS 0 OR 1
4. HISTOLOGICALLY CONFIRMED EARLY INVASIVE HER2-POSITIVE CARCINOMA OF THE BREAST WITH NO EVIDENCE OF RESIDUAL, LOCALLY RECURRENT OR METASTATIC DISEASE AND DEFINED AS CLINICAL STAGE I (T1, NO, MO) TO WC (ANY T, N3, MO) THAT IS ELIGIBLE FOR ADJUVANT TREATMENT WITH TRASTUZUMAB
NOTE: PATIENTS TREATED WITHOUT NEOADJUVANT OR ADJUVANT CHEMOTHERAPY, SUCH
AS PATIENTS WITH LOW RISK NODE NEGATIVE TUMOURS1.0 CM, ELDERLY PATIENTS (>65 YEARS OF AGE) OR PATIENTS WITH HER2-POSITIVE EBC BUT DENYING CHEMOTHERAPY, WILL ALSO BE ELIGIBLE TO PARTICIPATE IN THE STUDY, BUT THEIR ENROLMENT WILL BE LIMITED TO APPROXIMATELY 10% OF THE TOTAL STUDY POPULATION.
5. HER2-POSITIVE EBC, DEFINED AS IHC 3+, OR FISH/C1SH POSITIVE, AS DETERMINED IN A LOCAL LABORATORY THAT IS EXPERIENCED/CERTIFIED IN HER2- EXPRESSION TESTING USING AN ACCURATE AND VALIDATED ASSAY
6. SCREENING LEFT VENTRICULAR EJECTION FRACTION (LVEF) 55% AS MEASURED BY ECHOCARDIOGRAPHY, MULTI GATED ACQUISITION (MUGA) SCAN OR MAGNETIC RESONANCE IMAGING (MRI) PER LOCAL PRACTICE
Exclusion criteria:
CANCER RELATED CRITERIA:
1. PREVIOUS NEOADJUVANT OR ADJUVANT BREAST CANCER TREATMENT WITH AN APPROVED OR INVESTIGATIONAL ANTI-HER2 AGENT
2. HISTORY OF OTHER MALIGNANCY WHICH COULD AFFECT COMPLIANCE WITH THE PROTOCOL OR INTERPRETATION OF RESULTS. PATIENTS WITH CURATIVELY TREATED CARCINOMA IN SITU OF THE CERVIX OR BASAL CELL CARCINOMA, AND PATIENTS WITH OTHER CURATIVELY-TREATED MALIGNANCIES WHO HAVE BEEN DISEASE-FREE FOR AT LEAST 5 YEARS, ARE ELIGIBLE.
3. PAST HISTORY OF DUCTAL CARCINOMA IN SITU (DCIS) AND/OR LOBULAR CARCINOMA IN SITU (LCIS) THAT HAS BEEN TREATED WITH ANY SYSTEMIC THERAPY OR WITH RADIATION THERAPY TO THE IPSILATERAL BREAST WHERE INVASIVE CANCER SUBSEQUENTLY DEVELOPS. PATIENTS WHO HAD THEIR DCISILCIS TREATED WITH SURGERY ONLY ARE ALLOWED TO ENTER THE STUDY.
4. METASTATIC DISEASE
5. INADEQUATE BONE MARROW FUNCTION (AS INDICATED BY ANY OF THE FOLLOWING):
. TOTAL WHITE BLOOD CELL COUNT (WBC) < 2,5001 MM3 (<2.5 X 10⁹/L)
. ABSOLUTE NEUTROPHIL COUNT (ANC) < 1,5001 MM3 (< 1.5 X 10⁹/L)
. PLATELETS < 100,000 / MM3 (< 100 X 10⁹/L)
. HAEMOGLOBIN < 10 G/DL
6. IMPAIRED HEPATIC FUNCTION (AS INDICATED BY ANY OF THE FOLLOWING):
. SERUM TOTAL BILIRUBIN > 1.5 X UPPER LIMIT OF NORMAL (ULN)
. ALANINE AMINO TRANSFERASE (ALT) AND/OR ASPARTATE AMINO TRANSFERASE (AST) > 1.25 X ULN
. ALKALINE PHOSPHATASE (ALP) > 2.5 X ULN
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Weitere Informationen zur Studie
Datum der Studienregistrierung
12.12.2012
Einschluss der ersten teilnehmenden Person
01.01.1900
Rekrutierungsstatus
Complete
Wissenschaftlicher Titel
(Datenquelle: WHO)
A PHASE II PROSPECTIVE, TWO-COHORT NON-RANDOMIZED, MULTI-CENTRE, MULTINATIONAL, OPEN LABEL STUDY TO ASSESS THE SAFETY OF ASSISTED- AND SELF-ADMINISTERED SUBCUTANEOUS TRASTUZUMAB AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE EARLY BREAST CANCER [SAFEHER STUDY]
Studientyp
(Datenquelle: WHO)
Interventional
Design der Studie
(Datenquelle: WHO)
THIS IS A PHASE III, PROSPECTIVE, TWO-COHORT, NON-RANDOMIZED, MULTI-CENTRE, MULTINATIONAL, OPEN LABEL STUDY IN APPROXIMATELY 2,500 PATIENTS WITH HER2-PPSITIVE EBC WHOSE TUMOUR HAS BEEN EXCISED.
Phase
(Datenquelle: WHO)
III
Ergebnisse der Studie
(Datenquelle: WHO)
Zusammenfassung der Ergebnisse
noch keine Angaben verfügbar
Link zu den Ergebnissen im Primärregister
noch keine Angaben verfügbar
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
noch keine Angaben verfügbar
Studiendurchführungsorte
Durchführungsländer
(Datenquelle: WHO)
Albania, Arabia Saudi, Argentina, Australia, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Ecuador, Egypt, El Salvador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Indonesia, Ireland, Italy, Korea North, Lithuania, Malasya, Mexico, Morocco, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Romania, Russian Federation, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kindgdom, Venezuela
Kontakt für weitere Auskünfte zur Studie
Kontakt für allgemeine Auskünfte
(Datenquelle: WHO)
Hedwig
Schmidt
Calle Dionisio Derteano 144, Oficina 1201 - San Isidro
ROCHE FARMA (PERU) S.A.
618-8948
hedwig.schmidt@roche.com
Kontakt für wissenschaftliche Auskünfte
(Datenquelle: WHO)
Hedwig
Schmidt
Calle Dionisio Derteano 144, Oficina 1201 - San Isidro
ROCHE FARMA (PERU) S.A.
618-8948
hedwig.schmidt@roche.com
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