Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

NCT00691912 | Terminated Phase 2

• 1 other identifier: 4102000
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

Today metastatic breast cancer is regarded as cureless. The treatment is palliative in intent and the goals of treatment include improvement of quality of life and if possible prolongation of life. Treatment in metastatic cancer will usually involve hormone therapy and/or chemotherapy. Weekly application of chemotherapeutical drugs may lead to less drug concentrations in healthy tissue and therefore toxicities maý be reduced.

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival assessed by imaging procedures

  after 6 weeks, 12 weeks, 18 weeks

Secondary Outcomes (2)

• toxicity, quality of life

  every 3 weeks

• response rate, overall survival

  28 d after last Chemotherapy, up then every 3 months for 1 and a half year, and up then every 6 months until 5 years.

Study Arms (1)

Myocet/Paclitaxel

EXPERIMENTAL

20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d

Drug: liposomal Doxorubicin; Drug: Myocet / Paclitaxel

Interventions

liposomal Doxorubicin DRUG

20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d

Also known as: Myocet

Myocet/Paclitaxel

Myocet / Paclitaxel DRUG

20 mg/m² Myocet® as 30-minutes infusion on day 1,8,15 80 mg/m² Paclitaxel as 60-minutes infusion on day 1,8,15 q21d

Myocet/Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \>/= 18 years with histologically proven metastatic breast cancer
• No prior chemotherapy in the advanced situation
• ECOG \</= 2
• Adequate bone marrow reserve
• left ventricular ejection fraction (LVEF) \>/= 50, measured within 4 weeks before study treatment
• Existence of written informed consent

You may not qualify if:

• Previous high dose therapy with stem cell support
• Prior adjuvant treatment with cumulative anthracycline dose of 600 mg/m² Epirubicin, 300 mg/m² Doxorubicin, 80 mg/m² Mitoxantrone
• Concomitant hormon- or chemotherapy or radiation therapy
• Her2/neu overexpression
• pregnancy or breast feeding

Sponsors & Collaborators

• Claudia Lorenz-Schlüter: lead

Study Sites (1)

Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik

Magdeburg, Saxony-Anhalt, 39108, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin; Doxorubicin; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Joachim Bischoff, Dr. med.

  Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: member of CRO

Study Record Dates

• First Submitted: June 4, 2008
• First Posted: June 6, 2008
• Study Start: December 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 3, 2014

Record last verified: 2014-09

Locations

DE (1)