A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE PRIMARY BREAST CANCER

• Register: RPEC
• Last refreshed on: 13 November 2023
• Main ID: PER-027-14
• Date of registration: 26/08/2014
• Prospective Registration: No
• Primary sponsor: F. HOFFMANN-LA ROCHE LTD.,
• Public title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE PRIMARY BREAST CANCER
• Scientific title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III TRIAL COMPARING TRASTUZUMAB PLUS PERTUZUMAB PLUS A TAXANE FOLLOWING ANTHRACYCLINES VERSUS TRASTUZUMAB EMTANSINE PLUS PERTUZUMAB FOLLOWING ANTHRACYCLINES AS ADJUVANT THERAPY IN PATIENTS WITH OPERABLE HER2-POSITIVE PRIMARY BREAST CANCER
• Date of first enrolment: 01/07/2014
• Target sample size: 32
• URL: https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=027-14
• Study type: Interventional
• Study design: This is a prospective, two-arm, Phase III, randomized, multicenter, multinational, open-label; study in patients with newly diagnosed HER2-positive primary invasive breast cancer who have; had curative intent surgery of their primary tumor and are candidates for adjuvant systemic; chemotherapy following surgery. HER2-positive status of the primary tumor will be confirmed; by the central pathology laboratory prior to enrollment of the patient in the study. Approximately; 2500 patients will be randomized to one of the following treatment arms in a 1:1 ratio: • Arm 1: Protocol-approved anthracycline chemotherapy of choice followed by trastuzumab at; 6 mg/kg every 3 weeks (q3w; 8 mg/kg loading dose) in combination with pertuzumab; 420 mg q3w (840 mg loading dose) and paclitaxel (80 mg/m2) qw or docetaxel q3w (see; details of docetaxel dose and duration in the protocol). After the taxane concurrent phase,; HER2-t
• Phase: III

Countries of recruitment

Argentina, Australia, Austria, Belgium, Bosnial and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, El Salvador, France, French Polynesia, Georgia, Germany, Guatemala, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Islas Marshall, Israel, Italy, Japan, Korea South, Malasya, Mexico, New Zealand, Panama, Philippines, Poland, Portugal, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States

Contacts

• Name: Roberto Carrasco
• Affiliation: ROCHE FARMA (PERU) S.A.

• Name: Roberto Carrasco
• Affiliation: ROCHE FARMA (PERU) S.A.

Key inclusion & exclusion criteria

Inclusion criteria:
* Age≥ 18 years
• Eastern Cooperative Oncology Group performance status ≤1
• Non-metastatic histologically confirmed primary invasive breast carcinoma that was
operable
• HER2−positive breast cancer prospectively determined on the primary tumor by a
central pathology laboratory
* Known hormone receptor status of the primary tumor determined by a central
pathology laboratory
* Adequately excised: patients must have undergone either breast-conserving
surgery or mastectomy/nipple- or skin-sparing mastectomy
* Patients with synchronous bilateral invasive disease are eligible only if both lesions
are HER2-positive.
• No more than 9 weeks (63 days) may elapse between definitive breast surgery (or
the last surgery if additional resection required for breast cancer) and randomization.
• Baseline LVEF≥ 55% measured by ECHO (preferred) or MUGA scans
• Documentation of hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies is
required: this includes hepatitis B surface antigen (HBsAg) and/or total hepatitis B
core antibody (HBcAb) in addition to HCV antibody testing.

Exclusion criteria:
* History of any prior (ipsi- and/or contralateral) invasive breast carcinoma
• History of non-breast malignancies within the 5 years prior to study entry
* Any clinical T4 tumor as defined by tumor-node-metastasis classification in
UICC/AJCC 7th edition, including inflammatory breast cancer
* For the currently diagnosed breast cancer, any previous systemic anti-cancer
treatment (e.g., neoadjuvant or adjuvant), including, but not limited to,
chemotherapy, anti-HER2 therapy (e.g., trastuzumab, trastuzumab emtansine,
pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal
therapy, OR anti-cancer RT (intraoperative radiotherapy as a boost at the time of
primary surgery is acceptable)
• Previous therapy with anthracyclines, taxanes, or HER2-targeted therapy for any
malignancy
• History of DCIS and/or LCIS that was treated with any form of systemic
chemotherapy, hormonal therapy, or RT to the ipsilateral breast where invasive
cancer subsequently developed. Patients who had their DCIS/LCIS treated with
surgery only and/or contralateral DCIS treated with radiation are allowed to enter the
study.
• Patients with contraindication to RT while adjuvant RT is clinically indicated
• Concurrent anti-cancer treatment in another investigational trial
* Other concurrent serious diseases that may interfere with planned treatment,
including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled
diabetes, or known infection with HIV


Age minimum: 18
Age maximum: 80
Gender: --

Health Condition(s) or Problem(s) studied

C50

-C50 Malignant neoplasm of breast
Malignant neoplasm of breast

Intervention(s)

Research products to be used are: * Trastuzumab, doses: 6mg/kg weight, frequency: c/3sem. 4 cycles administered intravenously, FF: lyophilized for solution for injection; * Pertuzumab doses: 420mg, Frequency: c/3sem 4 cycles administered intravenously, FF: solution for injection, and trastuzumab emtansine *, 3.6mg / kg, frequency: c/3sem.4 cycles administered intravenously, FF: lyophilized for solution for injection. Population: over 18 years.

Source(s) of Monetary Support

Industria Farmaceutica

Ethics review

Status: Approved
Approval date: 21/01/2014
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 13/02/2014
Contact:

[e-mail]

Comite Institucional de Etica en Investigacion de la Asociacion Benefica Prisma

616-5500 Anx. 246

[e-mail]

Status: Approved
Approval date: 15/10/2014
Contact:

[e-mail]; [e-mail]

Hospital Nacional Carlos Alberto Seguin Escobedo - Arequipa

959383952

[e-mail]; [e-mail]

Status: Approved
Approval date: 23/04/2019
Contact:

[e-mail]

Via Libre

4331396

[e-mail]

Results

• Results available: Yes
• Date Completed: 12/04/2021