Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

This study has been completed.

Sponsor:

Collaborators:

Rigshospitalet, Denmark

Odense University Hospital

Aarhus University Hospital

Information provided by:

Herlev Hospital

ClinicalTrials.gov Identifier:

NCT01206881

First received: September 13, 2010

Last updated: June 30, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2010

Last Updated Date

June 30, 2011

Start Date ^ICMJE

March 2009

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

clinical response rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

evaluation of treatment efficacy every 2.cycle

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01206881 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

pathological response rate, response rate as defined by PET-CT scan, mammography and ultrasound, evaluation of toxicity of the combination regimen [ Time Frame: up to 30 weeks ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Neoadjuvant Pegylated Liposomal Doxorubicin and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Breast Cancer

Official Title ^ICMJE

A Phase II Study of Neoadjuvant Treatment With Pegylated Liposomal Doxorubicin (Caelyx) and Cyclophosphamide +/- Trastuzumab Followed by Docetaxel in Patients With Locally Advanced Breast Cancer

Brief Summary

The purpose of this study is to determine the efficacy of neoadjuvant treatment with pegylated liposomal doxorubicin (Caelyx) and cyclophosphamide +/- trastuzumab followed by docetaxel in patients with locally advanced, inflammatory breast cancer or with a primary tumor > 5 cm.

Detailed Description

Patients with locally advanced or inflammatory breast cancer have a very bad prognosis. Several studies have shown that patients who receive a pathological complete response have the best prognosis. Neoadjuvant chemotherapy including anthracyclines and taxanes has become established as a standard option in the multidisciplinary management of this group of patients. In HER2 positive patients, chemotherapy in combination with trastuzumab is therapeutically attractive. Recent studies have also demonstrated that evaluation with PET-CT scan can be used to stratify treatment and monitor early response to neoadjuvant therapy.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: pegylated liposomal doxorubicin

35 mg/m2, IV, day 1 every 21 days, 4 cycles

Other Names:

cyclophosphamide, 4 cycles
docetaxel, 4 cycles
trastuzumab, 8 cycles

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

pathologically proven breast cancer
inflammatory, locally advanced breast cancer or a tumor > 5 cm
ECOG performance status < 2
LVEF > 50% measured by MUGA (HER2 positive patients)
adequate bone marrow, liver and renal function
written informed consent must be obtained

Exclusion Criteria:

another malignancy within 5 years prior to study entry
concurrent treatment with an investigational agent
other disease or condition that contraindicates participation in the study
pregnant or lactating females

Gender

Female

Ages

18 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark

Administrative Information

NCT Number ^ICMJE

NCT01206881

Other Study ID Numbers ^ICMJE

PO5903, EudraCT 2008-007951-29

Has Data Monitoring Committee

Yes

Responsible Party

Malgorzata K. Tuxen, MD, phd, consultant, Department of Oncology, Herlev Hospital

Study Sponsor ^ICMJE

Herlev Hospital

Collaborators ^ICMJE

Rigshospitalet, Denmark
Odense University Hospital
Aarhus University Hospital

Investigators ^ICMJE

Principal Investigator:	Malgorzata K Tuxen, MD	Herlev Hospital, Department of Oncology
Principal Investigator:	Ulla B Tange, MD	Rigshospitalet, Denmark
Principal Investigator:	Soeren Cold, MD	Odense University Hospital
Principal Investigator:	Susanne B Søndergaard, MD	Herlev Hospital
Principal Investigator:	Henrik Petersen, MD	Odense University Hospital
Principal Investigator:	Inger Hoejris, MD	Aarhus University Hospital
Principal Investigator:	Anni Eskild-Jensen, MD	Aarhus University Hospital

Information Provided By

Herlev Hospital

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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