UnknownPhase 3

Alternative Non-cross-resistant Adjuvant Chemotherapy for Operable Breast Cancer Non-response to Primary Chemotherapy

China400 participantsStarted 2011-03-04

Plain-language summary

The purpose of this phase Ⅲ, multi-center, prospective, open-label, randomized,controlled study is to determine whether alternative non-cross-resistant adjuvant chemotherapy can increase distant disease free survival(DDFS) in operable patients non-response to primary chemotherapy.

Who can participate

Age range18 Years – 65 Years

SexFEMALE

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Inclusion criteria

✓. Absolute neutrophil count (ANC) ≥1500/mm3
✓. Platelets ≥100,000/ mm3
✓. Hemoglobin ≥10 g/dL
✓. Serum bilirubin ≤1.5×UNL
✓. Alkaline phosphatase and alanine aminotransferase (ALT) ≤2.5 x ULN. (≤5 x ULN is acceptable in the setting of hepatic metastasis)
✓. BUN between 1.7 and 8.3 mmol/L
✓. Cr between 40 and 110 umol/L

What they're measuring

distant disease-free survival (DDFS)

Timeframe: 3 years after surgery

Trial details

NCT IDNCT01019616

SponsorTao OUYANG

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

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