HER2-positive primary breast cancer. MedDRA version: 23.0 Level: PT Classification code 10065430 Term: HER2 positive breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Kadcyla
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 desc
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult patients, aged at least 18 years • Histologically confirmed invasive breast cancer with clinical staging T1-4, N0-3, M0 (no metastasis) • HER2-positive tumor as confirmed by central laboratory HER2 testing (immunohistochemistry and/or in-situ hybridization) • Patients must have received at least 6 cycles with 16 weeks of prior chemotherapy in the preoperative (neoadjuvant) setting including at least 9 weeks of a taxane and 9 weeks of HER2-directed therapy which may be given concurrently • Surgical removal of all clinically-evident disease in the breast and lymph nodes • Pathologic evidence of residual invasive cancer following completion of preoperative chemotherapy • ECOG performance status of 0 or 1 • Life expectancy of at least 6 months from the first dose of study treatment • Adequate organ function as determined by the following laboratory results, within 14 days prior to randomization. • Women of childbearing potential and men with partners of childbearing potential must be willing to use effective contraception as defined by protocol for the duration of study treatment and for at least 7 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 1200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 284
Exclusion criteria
Exclusion criteria: • Metastatic breast cancer • History of any prior breast cancer except for lobular carcinoma in situ • Treatment with a cumulative dose of epirubicin greater than 480mg/m2 or any other anthracycline like doxirubicin greater than 240mg/m2 • Treatment with any investigational anticancer drug within 28 days prior to commencing study treatment • History of other malignancy within the previous 5 years except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other malignancies with an expected curative outcome • Peripheral neuropathy greater or equal to Grade 2 • Uncontrolled cardiopulmonary dysfunction (e.g., high blood pressure, angina, serious cardiac arrhythmia) • Active liver disease like hepatitis • Other current, severe, uncontrolled systemic disease (e.g., clinically significant metabolic disease, wound healing disorders, ulcers) • For female patients, current pregnancy or lactation • Major surgical procedure or significant traumatic injury within 28 days prior to randomization or anticipation of the need for major surgery during the course of study treatment • Currrent, serious, uncontrolled Infections or known infection with HIV.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the length of time it takes for the primary breast cancer to recur after treatment with preoperative chemotherapy followed by surgery between the 2 treatment arms.;Secondary Objective: To compare the length of time it takes for: • the primary breast cancer to develop in other location(s) • occurrence of secondary cancers in other organs • death To compare side effects of the study medication between the 2 treatment arms.;Primary end point(s): Invasive disease-free survival (IDFS);Timepoint(s) of evaluation of this end point: up to 12 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. IDFS including second non-breast cancer 2. Disease-free survival (DFS), including second non-breast cancer or contralateral or ipsilateral ductal carcinoma in situ 3. Overall survival (OS) 4. Recurrence-free interval (RFI): time between randomization and local, regional or distant breast cancer recurrence 5. Distant recurrence-free interval (DRFI): time between randomization and distant breast cancer recurrence 6. Cardiac and overall safety: Incidence of adverse events 7. Quality of life: EORTC QLQ-C30, QLQ-BR23 and EQ-5D questionnaires.;Timepoint(s) of evaluation of this end point: 1 to 6. up to 12 years 7. up to 3 years | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, China, Colombia, Czechia, Czech Republic, France, Germany, Greece, Guatemala, Hong Kong, Ireland, Israel, Italy, Mexico, Panama, Peru, Russian Federation, Serbia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
F. Hoffmann-La Roche Ltd
Outcome results
None listed