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]

• Register: RPEC
• Last refreshed on: 4 September 2023
• Main ID: PER-051-12
• Date of registration: 12/12/2012
• Prospective Registration: Yes
• Primary sponsor: F. HOFFMANN-LA ROCHE LTD.,
• Public title: 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]
• Scientific title: 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]
• Date of first enrolment: 01/01/1900
• Target sample size: 30
• Recruitment status: Complete
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=051-12
• Study type: Interventional
• Study design: 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: III

Countries of recruitment

Albania, Arabia Saudi, Argentina, Argeria, 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

Contacts

• Name: Hedwig Schmidt
• Affiliation: ROCHE FARMA (PERU) S.A.

• Name: Hedwig Schmidt
• Affiliation: ROCHE FARMA (PERU) S.A.

Key inclusion & exclusion criteria

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 TUMOURS 1.0 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


Age minimum: 18
Age maximum: 99
Gender: --

Intervention(s)

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.

Ethics review

Status: Approved
Approval date: 09/02/2012
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 29/03/2012
Contact:

[e-mail]

Instituto Nacional de Enfermedades Neoplasicas

7106099-3001

[e-mail]

Status: Approved
Approval date: 12/04/2012
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 25/10/2012
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 22/06/2017
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Results

• Results available: Yes
• Date Completed: 29/01/2020