Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer (Neo-shorter)

Asan Medical Center

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: FEC3-D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02001506

2012-0116

Details and patient eligibility

About

Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.

Full description

To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Enrollment: 250 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Performance status 0 or 1
• Clinically stage 2 or 3 with histologically proven lymph node involvement
• Tumor or lymph node greater than 1.5 cm

Exclusion criteria

• Pregnancy or lactation
• Prior chemotherapy or radiotherapy for any malignancy
• Documented history of cardiac disease contraindicating anthracyclines
• Currently active infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

FEC3-D3

Active Comparator group

Description:

3 cycles of FEC followed by 3 cycles of Docetaxel Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks

Treatment:

Drug: FEC3-D3

AC4-D4

No Intervention group

Description:

4 cycles of Adriamycin plus Cyclophosphamide (AC) followed by 4 cycles of Docetaxel Adriamycin 60 mg/m2, every 3 weeks Cyclophosphamide 600 mg/m2, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks