Amendment 1 was issued before any patients were enrolled into the study. • An Independent Safety Data Monitoring Committee was set-up to review the patients safety events including: - suspected unexpected serious adverse reactions, - All grade 3, 4 or 5 non-hematologic AEs (grading according to NCI CTCAE version 3.0), - Febrile neutropenia, - Thrombocytopenia with hemorrhage, - Events of interest, such as symptomatic cardiac function failure (NYHA Class 3 or 4) or asymptomatic decrease in LVEF. • The Steering Committee reviewed and implemented the recommendation issued by the Independent Safety Data Monitoring Committee.

Amendment 2 was issued before any patients were enrolled into the study. • In the primary objective, the primary efficacy variable was clarified to indicate the proportion of patients who achieve pCR in breast. • The secondary objectives were updated and 2 additional secondary objectives were to be evaluated: - The proportion of patients who achieve pCR in breast and axillary lymph node. - The proportion of patients with conservative surgery. • SISH and CISH tests, in addition to the FISH test, were allowed to check the amplification of the HER2 gene. These 2 tests were the reference tests in some European centers. • Additional information concerning diagnosis biopsy and SLN procedure have been included as follows: - Introduction of a tumor clip at the time of the diagnosis biopsy is highly recommended. - Pre-treatment SLN is not a standard procedure but is acceptable for clinical stage T2, N0 patients. • The following statement was deleted concerning anti estrogen or anti aromatase hormonal treatment: - Patients with ER positive tumors will be allowed to receive anti estrogen or anti aromatase hormonal treatment at the discretion of the investigator. • The timing of the postsurgical visit was clarified from Postsurgical follow-up to end of cycle 8/Postsurgical visit. • The number and timing of mammography/MRI procedures to be performed was changed to avoid unnecessary repetition of these procedures. • Clarification concerning the breast surgery and axillary dissection as follows: The patient will then undergo surgery: mastectomy or breast conservative surgery that must remove all residual tumor providing clear margins (>2 mm). Axillary dissection is mandatory in the absence of pre-treatment negative SLN. • The timing for platelet and absolute neutrophil counts was modified to avoid unnecessary repetition of procedures; the number of blood tests was reduced from a weekly schedule at each cycle to a weekly schedule for selected cycles.

Amendment 3 was issued after 122 patients were enrolled. • The planned study end date and the duration of the study were changed to the last patient last visit by third quarter 2012 including the 2-year follow-up period, with a duration of 48 months. The expected study end date and duration were updated according to currently available information on patients’ inclusion and accrual rates and a clarification was added indicating that the end of the study was after the 2-year follow-up period. • A sentence was added in order to clarify that all patients who received treatment should still be monitored after they stopped receiving study treatment for up to 2 years from randomization. • In Appendix D of the protocol (NYHA Functional Classification of Cardiac Disease), the presentation of the NYHA classification was modified in order to clarify that patients with no cardiac disease should not be classified according the Functional Capacity Class and to avoid any confusion between the Functional Capacity Class and the Objective Assessment. • In Appendix F (WHO criteria of tumor response) of the protocol, the table for the determination of overall response was simplified.

Amendment 4 (dated 23 February 2011) to the protocol was issued after 125 patients were enrolled. Administrative changes in study personnel (sponsor’s medical expert and contact person for medical issues) were made to the protocol.

Amendment 5 (dated 29 February 2012) to the protocol was issued after 125 patients were enrolled. • The duration of follow-up for PFS and cardiac insufficiency was changed from 2 to 5 years so that data on PFS and cardiac insufficiency were collected for 3 more years. • The duration of the study and the expected completion date were changed (last patient last visit by third quarter 2015 including the 5-year follow-up period, with a duration of 84 months) so that data on PFS and cardiac insufficiency were collected for 3 more years. • The number of study visits was updated to include additional visits during the extended posttreatment follow-up period and the study flowchart was updated accordingly. • The description of study periods requiring AEs and SAEs reporting was clarified. • The description of study periods requiring SAEs reporting was clarified. • The duration of follow-up for LVEF was changed from 2 to 5 years.

Amendment 6 (dated 29 November 2012) to the protocol was issued after 125 patients were enrolled. • The sponsor was changed from Cephalon to Teva. • Administrative changes in personnel were made.