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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01206881
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : July 4, 2011
Rigshospitalet, Denmark
Odense University Hospital
Aarhus University Hospital
Information provided by:
Herlev Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: pegylated liposomal doxorubicin Phase 2

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2009
Primary Completion Date : May 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Intervention Details:
    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

Primary Outcome Measures :
  1. clinical response rate [ Time Frame: 24 weeks ]
    evaluation of treatment efficacy every 2.cycle

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01206881

Aarhus University Hospital
Aarhus, Denmark, 8200
Copenhagen, Denmark, 2100
Herlev Hospital
Herlev, Denmark
Odense University Hospital
Odense, Denmark, 5000
Sponsors and Collaborators
Herlev Hospital
Rigshospitalet, Denmark
Odense University Hospital
Aarhus University Hospital
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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Malgorzata K. Tuxen, MD, phd, consultant, Department of Oncology, Herlev Hospital Identifier: NCT01206881     History of Changes
Other Study ID Numbers: PO5903, EudraCT 2008-007951-29
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: July 4, 2011
Last Verified: June 2011

Keywords provided by Herlev Hospital:
breast cancer
liposomal doxorubicin
PET scan

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors