Study: NCT03272477

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: 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

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Cyclophosphamide
Description: 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

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Anastrozole
Description: 1mg per day for a total of 40 weeks in adjuvant therapy phase

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Letrozole
Description: 2,5 mg/day for a total of 40 weeks in adjuvant therapy phase

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Exemestane
Description: 25mg/day for a total of 40 weeks in adjuvant therapy phase

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Leuprorelin acetate
Description: 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.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Goserelin
Description: 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.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anastrozole
Description: 1mg per day for 12 weeks in neoadjuvant therapy phase; 1mg per day for a total of 40 weeks max. in adjuvant therapy phase

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Letrozole
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Exemestane
Description: 25mg/day for 12 weeks in neoadjuvant therapy phase; 25mg/day for a total of 40 weeks max. in adjuvant therapy phase

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel
Description: 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

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Tamoxifen
Description: 20mg per day (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leuporelin acetate
Description: 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).

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Goserelin
Description: 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).

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Biopsy
Description: Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Biopsy
Description: Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Surgery
Description: Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)