257
Participants
Start Date
October 5, 2017
Primary Completion Date
July 14, 2020
Study Completion Date
March 4, 2024
Perjeta Injectable Product
Single dose of 840mg (loading dose) day1 cycle 1, 420mg at day1 of each subsequent cycle, every 3 weeks. (The latter cycle is called cycle of treatment and is to be given 4 times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Herceptin
Single dose of 8mg/kg (loading dose) day1 cycle 1; 6mg/kg at day1 of each subsequent cycle body weight every 3 weeks. (This is called cycle of treatment and is to be given four times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
Tamoxifen
20 mg per day for a total of 40 weeks in the adjuvant therapy phase.
Paclitaxel
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment and is to be given for 12 weeks in neoadjuvant therapy phase.
Epirubicin
12 weeks (4cycles) of max. 90mg/sqm in adjuvant therapy phase
Cyclophosphamide
12 weeks (4cycles) of 600 mg/sqm i.v. on day 1+8 or 12 weeks (4cycles) of 500 mg/sqm i.v. on day 1 in adjuvant therapy phase
Anastrozole
1mg per day for a total of 40 weeks in adjuvant therapy phase
Letrozole
2,5 mg/day for a total of 40 weeks in adjuvant therapy phase
Exemestane
25mg/day for a total of 40 weeks in adjuvant therapy phase
Leuprorelin acetate
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
Goserelin
3,6mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
Anastrozole
1mg per day for 12 weeks in neoadjuvant therapy phase; 1mg per day for a total of 40 weeks max. in adjuvant therapy phase
Letrozole
2,5 mg per day for 12 weeks in neoadjuvant therapy phase; 2,5 mg perday for a total of 40 weeks max. in adjuvant therapy phase
Exemestane
25mg/day for 12 weeks in neoadjuvant therapy phase; 25mg/day for a total of 40 weeks max. in adjuvant therapy phase
Paclitaxel
80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment an is to be given for 12 weeks in the adjuvant phase
Tamoxifen
20mg per day (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase.
Leuporelin acetate
One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
Goserelin
3,5mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
Biopsy
Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)
Surgery
Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)
Evangelisches Krankenhaus Bethesda Mönchengladbach, Mönchengladbach
Lead Sponsor
Roche Pharma AG
INDUSTRY
WSG WOMEN´S HEALTHCARE STUDY GROUP
UNKNOWN
Cankado GmbH
INDUSTRY
Palleos Healthcare GmbH
INDUSTRY