A Prospective, Multicenter, Open-label 12 Week Neoadjuvant Phase II Trial Optimizing Taxane Therapy in Elderly Patients With Low Response

Phase 3

Active, not recruiting

• Conditions: Early Primary Breast Cancer
• Interventions: Drug: Myocet; Drug: Cyclophosphamide; Drug: Paclitaxel

• Registration Number: NCT02214381
• Lead Sponsor: West German Study Group

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-31
• Study First Submitted QC: 2014-08-07
• Study First Posted: 2014-08-12
• Primary Completion: 2015-10
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mycet/Cyclophosphamid	Myocet	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.
Mycet/Cyclophosphamid	Cyclophosphamide	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.
Myocet/Cyclophosphamide/Paclitaxel	Cyclophosphamide	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.
Myocet/Cyclophosphamide/Paclitaxel	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.
Myocet/Cyclophosphamide/Paclitaxel	Myocet	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.

Primary Outcome Measures

Name	Time	Method
Comparison of pCR rates in patients with early response and no severe toxicity (Group 1) and in other patients (Group 2).	After 5 years of follow-up.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Ev. Krankenhaus Bethesda Brustzentrum Niederrhein; 🇩🇪 Moenchengladbach, Germany

Breast Center of the University of Munich (LMU) Universitätsfrauenklinik Großhadern; 🇩🇪 Munich, Germany