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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 July 2015
Main ID:  EUCTR2012-004902-82-ES
Date of registration: 05/12/2013
Prospective Registration: Yes
Primary sponsor: F. Hoffmann-La Roche Ltd
Public title: A Study of trastuzumab emtansine Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane 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: 27/01/2014
Target sample size: 2500
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004902-82
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Argentina Australia Belgium Bosnia and Herzegovina Brazil Canada Chile Colombia
Czech Republic El Salvador France Georgia Germany Guatemala Hong Kong Hungary
Israel Italy Japan Korea, Republic of Mexico Norway Panama Peru
Philippines Poland Portugal Romania Russian Federation Singapore South Africa Spain
Sweden Switzerland Taiwan Thailand Ukraine United Kingdom United States
Contacts
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F. Hoffmann-La Roche Ltd
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F. Hoffmann-La Roche Ltd
Key inclusion & exclusion criteria
Inclusion criteria:
- Adult patients, >/= 18 years of age
- Eastern Cooperative Oncology Group (ECOG) performance status - Non-metastatic histologically confirmed primary invasive breast carcinoma that was operable
- HER2-positive breast cancer
- Known hormone receptor status of the primary tumor
- Adequately excised: patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
- Pathological tumor-node-metastasis staging (Union for International Cancer Control-American Joint Committee on Cancer [UICC/AJCC] 7th edition): Eligible patients must have either:
? Node-positive disease (pN >/= 1), any tumor size except T0, and any hormonal receptor status, or
? Node-negative disease (pN0) with pathologic tumor size >2.0 cm by standard local assessment AND negative for ER and PR determined by a central pathology laboratory
- 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 - Female patients of childbearing potential must be willing to use one highly effective form of nonhormonal contraception or two effective forms of nonhormonal contraception. For male patients with partners of childbearing potential, one highly effective form of contraception or two effective forms of contraception must be used. Contraception must continue for the duration of study treatment and for 6 months after the last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2340
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

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, except for carcinoma in situ (CIS) of the cervix, CIS of the colon, melanoma in situ, and basal cell and squamous cell carcinomas of the skin
- 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 radiation therapy (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
- Cardiopulmonary dysfunction as defined by protocol
- Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease
? Significant symptoms (Grade >/=2) relating to left ventricular dysfunction, cardiac arrhythmia, or cardiac ischemia
? Myocardial infarction within 12 months prior to randomization
? Uncontrolled hypertension o
? Evidence of transmural infarction on ECG
? Requirement for oxygen therapy
- Other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions/illness, uncontrolled infections, uncontrolled diabetes, or known infection with HIV
- Any known active liver disease. For patients who are known carriers of HBV, active hepatitis B infection must be ruled out per local guidelines
- Inadequate hematologic, renal or liver function
- Pregnant or lactating women
- Hypersensitivity to any of the study medications or any of the ingredients or excipients of these medications, including hypersensitivity to benzyl alcohol
- Chronic immunosuppressive therapies, including systemic corticosteroids.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Diseases [C] - Cancer [C04]
HER2-positive operable primary breast cancer.
MedDRA version: 14.1 Level: PT Classification code 10065430 Term: HER-2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intervention(s)

Product Name: trastuzumab emtansine
Product Code: RO5304020/F02-01
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: trastuzumab emtansine
CAS Number: 1018448-65-1
Current Sponsor code: RO5304020
Other descriptive name: T-DM1, Trastuzumab-MCC-DM1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 160-

Trade Name: HERCEPTIN®
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: TRASTUZUMAB
CAS Number: 180288-69-1
Current Sponsor code: Ro 045-2317
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Trade Name: PERJETA®
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PERTUZUMAB
CAS Number: 380610-27-5
Current Sponsor code: Ro 436-8451
Other descriptive name: rhuMAb 2C4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-

Trade Name: Docetaxel
Pharmaceutical Form: Concentrate and solvent for solution for infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 20-

Trade Name: PACLITAXEL
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: PACLITAXEL
CAS Number: 33069-62-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-

Primary Outcome(s)
Primary end point(s): Invasive disease-free survival (IDFS), defined as time from randomization to occurrence of ipsilateral breast cancer recurrence, second primary invasive breast cancer, distant recurrence, or death of any cause.
Main Objective: To compare IDFS (Invasive Disease Free Survival) (1) in the node-positive subpopulation and (2) in the overall protocol?defined population of patients between the two treatment arms.
Timepoint(s) of evaluation of this end point: up to approximately 10 years
Secondary Objective: ? To compare IDFS plus second non-breast primary cancers, DFS(Disease Free Survival), and distant recurrence-free interval (DRFI) (1) in the node-positive subpopulation and (2) in the overall protocol defined population between the two treatment arms.
? To compare OS (1) in the node-positive subpopulation and (2) in the overall protocol-defined population between the two treatment arms.

Safety Objectives:
? To compare overall safety, cardiac safety, hepatic, and pulmonary safety between the two treatment arms.

Patient-reported Outcome (PRO) Objectives:
? To compare PROs of treatment-related symptoms, patient functioning, and health-related quality of life (HRQoL) between the two treatment arms.
Secondary Outcome(s)
Secondary end point(s): ? IDFSplus second primary non-breast cancer, excluding non-melanoma skin cancers and carcinoma in situ of any site
? Disease-free survival (DFS), defined as time between randomization and first occurrence of IDFS, second primary non-breast cancer and contralateral or ipsilateral ductal carcinoma in situ (DCIS)
? Distant recurrence-free interval (DRFI), defined as time between randomization and first occurrence of distant breast cancer recurrence
? Overall Survival (OS)
? Safety: Incidence of adverse events
Timepoint(s) of evaluation of this end point: up to approximately 10 years
Secondary ID(s)
2012-004902-82-IT
BO28407
Source(s) of Monetary Support
F. Hoffmann-La Roche Ltd
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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