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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.
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Inclusion and exclusion criteria
General Inclusion Criteria for ADAPT:
Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
Candidate for chemotherapy on the basis of conventional criteria
Histologically confirmed unilateral primary invasive carcinoma of the breast
Clinical T1 - T4a-c
All clinical N (cN)
No clinical evidence for distant metastasis (M0)
Known HR status and HER2 status (local pathology)
Tumor block available for central pathology review
Performance Status ECOG <= 1 or KI >= 80%
Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
The patient must be accessible for treatment and follow-up
Patients must qualify for neoadjuvant treatment
LVEF > 50%; LVEF within normal limits of each institution measured by echocardiography and normal ECG (within 42 days prior to chemotherapy)
Laboratory requirements :
Additional inclusion criteria ADAPT Elderly:
General Exclusion Criteria for ADAPT:
Additional Exclusion Criteria ADAPT Elderly:
Primary purpose
Allocation
Interventional model
Masking
80 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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