Conditions: Breast Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 3299
Healthy volunteers: no

Brief summary:
Primary objective :

* To compare disease-free survival after treatment with docetaxel in combination with doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive axillary lymph nodes.

Secondary objectives :

* To compare toxicity and quality of life between the 2 above-mentioned arms.
* To evaluate pathologic and molecular markers for predicting efficacy.

Detailed description:

Arms:
arm 1: Doxorubicin in combination with cyclophosphamide followed by docetaxel (AC -\> T) arm 2: Docetaxel in combination with doxorubicin and cyclophosphamide (TAC)

Interventions: intervention 1: docetaxel, doxorubicin, cyclophosphamide intervention 2: Docetaxel,doxorubicin, cyclophosphamide
Intervention descriptions: intervention 1: TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel. intervention 2: AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.

Protocol document: