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A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients


Phase 2
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

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Trial Information

A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients


To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line
chemotherapy in patient with advanced breast cancer


Inclusion Criteria:



- Age 18-75 years

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet
count>100000/mm^3, Hemoglobin>9gr/mm^3)

- Histologically- or cytologically- confirmed breast adenocarcinoma

- No prior anthracycline-based chemotherapy as treatment of advanced breast cancer

- No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as
adjuvant setting

- At least 4 weeks interval since prior anticancer treatment

- Measurable disease as defined by the presence of at least one measurable
lesion(except bone metastases, ascites or pleural effusions)

- Life expectancy > 3 months

- Written informed consent

Exclusion Criteria:

- Pregnancy or nursing

- Documented history of congestive heart failure (CHF), serious arrhythmia, or
myocardial infarction (within 6 months)

- Other invasive malignancy except nonmelanoma skin cancer or acute infection.

- Radiation of measurable disease (except brain metastases)

- Progressive brain metastases according to clinical or radiological criteria.

- Brain metastases without prior radiation therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of antitumor efficacy by objective tumor response rates

Outcome Time Frame:

Objective responses confirmed by CT or MRI (on 3rd and 6th cy)

Safety Issue:

No

Principal Investigator

Dimitris Mavrudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital of Crete

Authority:

Greece: National Organization of Medicines

Study ID:

CT/03.12

NCT ID:

NCT00431795

Start Date:

June 2003

Completion Date:

June 2012

Related Keywords:

  • Breast Cancer
  • Advanced breast cancer
  • Pegylated liposomal doxorubicin
  • Epirubicin
  • Breast Neoplasms

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