This study is a randomized, single center, phase III clinical trial comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC\*4-T\*4) verses 6 cycles of weekly paclitaxel combined with carboplatin (PCb\*6) in the adjuvant chemotherapy of non-triple negative breast cancer patients. The study is divided in to 2 branches: PANSY-1 and PANSY-2. PANSY-1 is a study of hormone receptor (HR)-positive/human epidermal growth factor receptor-2 (HER2)-negative patients with ≥4 positive lymph node, while PANSY-2 is a study of HER2-positive patients with ≥1 positive lymph node.
PANSY-1 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel (EC-T) verses six cycles of paclitaxel combined with carboplatin (PCb). PANSY-2 will be comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab (EC-TH) verses six cycles of paclitaxel combined with carboplatin and trastuzumab (PCbH); both followed by 1 year adjuvant trastuzumab. After pertuzumab became legally available in China, participants of PANSY-2 may choose to receive trastuzumab and pertuzumab dual targeted therapy, thus comparing the efficacy and safety of four cycles of epirubicin combined with cyclophosphamide followed by four cycles of docetaxel with trastuzumab and pertuzumab (EC-THP) verses six cycles of paclitaxel combined with carboplatin, trastuzumab and pertuzumab (PCbHP); both followed by 1 year adjuvant trastuzumab and pertuzumab. With the inclusion of pertuzumab in China's medical insurance in January 2020, study protocols were revised to include dual targeted therapy for HER2-positive participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,560
paclitaxel 80 mg/m\^2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
epirubicin 90 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.
cyclophosphamide 600 mg/m\^2 iv d1, 21 days per cycle, 4 cycles.
trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy; or trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).
pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant pertuzumab (420mg ivgtt every 3 weeks).
docetaxel 100 mg/m\^2 ivgtt d1, 21 days per cycle, 4 cycles.
Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
disease free survival
Time frame: 5 years
Invasive Disease Free Survival
Time frame: 5 years
Distant Disease Free Survival
Time frame: 5 years
Overall Survival
Time frame: 5 years
Number of Participants with Treatment Related Adverse Events as Assessed by CTCAE v4.0
Graded according to Common Terminology Criteria for Adverse Events (CTC-AE) 4.0 according to CTC-AE 4.0
Time frame: 5 years
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