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
  Purpose

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 Intervention Phase
Breast Cancer
Drug: pegylated liposomal doxorubicin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Herlev Hospital:

Primary Outcome Measures:
  • clinical response rate [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    evaluation of treatment efficacy every 2.cycle


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 45
Study Start Date: March 2009
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206881

Locations
Denmark
Aarhus University Hospital
Aarhus, Denmark, 8200
Rigshospitalet
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
Investigators
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
  More Information

No publications provided

Responsible Party: Malgorzata K. Tuxen, MD, phd, consultant, Department of Oncology, Herlev Hospital
ClinicalTrials.gov Identifier: NCT01206881     History of Changes
Other Study ID Numbers: PO5903, EudraCT 2008-007951-29
Study First Received: September 13, 2010
Last Updated: June 30, 2011
Health Authority: Denmark: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Trastuzumab
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic

ClinicalTrials.gov processed this record on July 24, 2014