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Clinical Trials/NCT02214381
NCT02214381CompletedPhase 3

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.

West German Study Group2 sites in 1 country80 target enrollmentStarted: July 2014Last updated:
Conditions
Interventions
Drugs

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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

Active Comparator

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.)

Investigators

Sponsor
West German Study Group
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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