A Prospective, Multicenter, Open-label 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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Mycet/Cyclophosphamid
4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.
Intervention: Myocet (Drug)
Mycet/Cyclophosphamid
4 x Myocet 60 mg/m² q3w in combination with 4 x cyclophosphamide 600 mg/m² q3w depending on early response assessment by ultrasound or on toxicity profile.
Intervention: Cyclophosphamide (Drug)
Myocet/Cyclophosphamide/Paclitaxel
2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
Intervention: Myocet (Drug)
Myocet/Cyclophosphamide/Paclitaxel
2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
Intervention: Cyclophosphamide (Drug)
Myocet/Cyclophosphamide/Paclitaxel
2 x Myocet 60 mg/m² q3w in combination with 2 x cyclophosphamide 600 mg/m² q3w followed by 6 x paclitaxel 80 mg/m² q1w depending on early response assessment by ultrasound or on toxicity profile.
Intervention: Paclitaxel (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Number of pCR in non-responders to MC.(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(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.(After 5 years of follow-up.)
- Incidence of febrile neutropenia (FN) after 1 x MC in patients with primary prophylaxis (PP) vs. others.(After 5 years of follow-up.)