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Multicenter Phase III Randomized Trial Comparing Doxorubicin And Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin And Cyclophosphamide Followed By Docetaxel And Trastuzumab (AC-TH) And With Docetaxel, Carboplatin And Trastuzumab (TCH) In The Treatment Of Node Positive And High Risk Node Negative Adjuvant Patients With Operable Breast Cancer Containing The HER2NEU Alteration.

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Trial Profile

Multicenter Phase III Randomized Trial Comparing Doxorubicin And Cyclophosphamide Followed By Docetaxel (AC-T) With Doxorubicin And Cyclophosphamide Followed By Docetaxel And Trastuzumab (AC-TH) And With Docetaxel, Carboplatin And Trastuzumab (TCH) In The Treatment Of Node Positive And High Risk Node Negative Adjuvant Patients With Operable Breast Cancer Containing The HER2NEU Alteration.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2022

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At a glance

  • Drugs Trastuzumab (Primary) ; Carboplatin; Cyclophosphamide; Docetaxel; Doxorubicin
  • Indications Breast cancer; HER2 positive breast cancer
  • Focus Registrational; Therapeutic Use
  • Sponsors Sanofi

Most Recent Events

  • 02 Feb 2022 Results published in the Clinical Cancer Research
  • 28 Aug 2020 Results (n=1770) of pooled analysis assessing long-term outcomes (iDFS and OS) of patients from APT trial (NCT00542451) vs matched external controls from five studies ((BCIRG 006 [NCT00021255], NSABP-B31 [NCT00004067], HERA [NCT00045032], N-9831 [NCT00005970], and APHINITY [NCT01358877])), published in the Annals of Oncology.
  • 14 Dec 2019 Results of exploratory analysis of survival outcomes comparing adjuvant paclitaxel and trastuzumab trial (APT) to an external control from historical clinical trials (BCIRG 006, NSABP-B31, HERA, N-9831, and APHINITY), presented at the 42nd Annual San Antonio Breast Cancer Symposium.

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