Therapy of Metastatic Breast Cancer With Paclitaxel and L... | NCT00691912

Studies
Therapy of Metastatic Breast Cancer With Paclitaxel and Liposomal Doxorubicin

NCT00691912

Sponsor

Claudia Lorenz-Schlüter

Status

Terminated

Last Update Posted

Sep 3, 2014Estimated

Enrollment

26Actual

Phase

Phase 2

Conditions

Metastatic Breast Cancer

Interventions

liposomal Doxorubicin
Myocet / Paclitaxel

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was stopped due because recrutation.was much slower as anticipated.

Expanded Access Info

Start Date

Dec 2006

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jun 4, 2008

First Submission Date that Met QC Criteria

Jun 5, 2008

First Posted Date

Jun 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2014

Last Update Posted Date

Sep 3, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Lorenz-Schlüter, member of CRO, University of MagdeburgSponsor-Investigator

Lead Sponsor

Claudia Lorenz-SchlüterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Breast cancer is the most common malignancy of females. In Germany about 46,000 women come down with breast cancer yearly.

Present therapies cannot cure the metastatic disease, the main focus is improvement of quality of life and prolongation of life. It is therefore necessary to test new substances and/or new combinations and therapy concepts. Among the most active cytotoxic agents used in advanced breast cancer are the anthracyclines. Since conventional anthracyclines are often used as adjuvant or neoadjuvant therapy their cardiotoxicity restricts their use in the therapy of the advanced disease.

Liposomal encapsulated doxorubicin shows better activity than conventional doxorubicin combined with reduced cardiotoxicity.

Weekly applied cytotoxic agents show a better toxicity profile and hence the cumulative dosis can be increased. It is expected that the combination of liposomal encapsulated doxorubicin with paclitaxel given weekly shows improved results in the therapy of metastatic breast cancer.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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	Myocet/Paclitaxel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival assessed by imaging procedures		after 6 weeks, 12 weeks, 18 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim Bischoff, Dr. med.	Klinikum der Otto-von-Guericke Universität Magdeburg, Frauenklinik	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum der Otto-von Guericke Universität Magdeburg, Frauenklinik		Magdeburg	Saxony-Anhalt	39108	Germany

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C506643	liposomal doxorubicin
D004317	Doxorubicin
D017239	Paclitaxel

Ancestor Terms

ID	Term
D003630	Daunorubicin
D018943	Anthracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons

Browse Leaves

Not provided

Browse Branches

Not provided