Comparison of pre-surgical Myocet/ Cyclophosphamide (MC) q3w followed by either MC or Paclitaxel - depending on early response assessment by ultrasound or by toxicity for elderly non frail primary breast cancer patients with increased risk of relapse.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Ev. Krankenhaus Bethesda Brustzentrum Niederrhein
Mönchengladbach, Germany
Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern
Munich, Germany
Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).
Time frame: After 5 years of follow-up.
Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others.
Time frame: After 5 years of follow-up.
Toxicity in the 4 x MC versus 2 x MC followed 6 x Pac arm as measured by adverse events.
Time frame: After 5 years of follow-up.
Number of pCR in non-responders to MC.
Time frame: After 5 years of follow-up.
G-CSF use in terms of primary or secondary prophylaxis per patient including occurence febrile neutropenia per patient per cycle
Time frame: After 5 years of follow-up.
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