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Trial record 10 of 12 for:    "Breast Ductal Carcinoma" | "Topoisomerase Inhibitors"

Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic 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: NCT00960336
Recruitment Status : Completed
First Posted : August 17, 2009
Last Update Posted : October 29, 2014
Information provided by (Responsible Party):

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride liposome, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well doxorubicin hydrochloride liposome works as first-line therapy in treating older women with metastatic breast cancer.

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

Detailed Description:



  • Evaluate the effectiveness of pegylated liposomal doxorubicin hydrochloride, in terms of objective response rate, in elderly women with metastatic breast cancer.


  • Determine the feasibility of this drug in these patients.
  • Evaluate chemotherapy-induced toxicities in these patients.
  • Assess the disease-free survival and overall survival of these patients.
  • Study the geriatric covariates.
  • Assess the covariates predictive of the hematopoietic reserve and the risk of febrile neutropenia in these patients.

OUTLINE: This is a multicenter study.

Patients receive pegylated liposomal doxorubicin hydrochloride IV over 60-90 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity or progressive disease.

After completion of study therapy, patients are followed up periodically for 2 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter Study of PEGylated Liposomal Doxorubicin in Geriatric Oncology - Metastatic Breast Cancer - First-line Treatment PEGylated Liposomal Doxorubicin in Patients Older Than 70 Years, Breast Cancer Metastasis
Study Start Date : March 2008
Actual Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: single arm Drug: pegylated liposomal doxorubicin hydrochloride

Primary Outcome Measures :
  1. Response rate [ Time Frame: 3 and 6 cures ]

Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Histologically confirmed invasive ductal or lobular adenocarcinoma of the breast

    • Metastatic disease as confirmed by ≥ 1 of the following:

      • Histology or cytology
      • Radiology
      • Elevated CA 15-3 levels
  • No HER2/neu overexpression by IHC or FISH
  • Measurable (≥ 10 mm) or evaluable disease

    • Bone lesions or isolated pleural effusion allowed
  • Hormone receptor status not specified


  • Postmenopausal
  • Life expectancy > 3 months
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9 g/dL
  • AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 5 times ULN
  • Bilirubin ≤ 2 times ULN
  • Creatinine clearance ≥ 30 mL/min
  • LVEF ≥ 50%
  • No congestive heart failure or other uncontrolled cardiac disease
  • No other malignancy within the past 5 years except for curatively treated carcinoma in situ of the cervix, urothelial in situ carcinoma, or basal cell cancer
  • No prior hypersensitivity to anthracyclines
  • No psychological, familial, social, or geographical reason that would preclude study follow-up
  • No serious illness or physical or mental condition resulting in a permanent disability that may preclude successful treatment


  • No prior chemotherapy for metastatic disease
  • Prior adjuvant chemotherapy allowed

    • No development of metastatic disease within 6 months after completion of adjuvant anthracycline-based chemotherapy
  • No more than 300 mg/m² of prior doxorubicin hydrochloride or 600 mg/m² of prior epirubicin hydrochloride in the adjuvant setting
  • More than 30 days since prior participation in another clinical trial

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): NCT00960336

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Hotel Dieu de Paris
Paris, France, 75181
Sponsors and Collaborators
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Principal Investigator: Laure Chauvenet, MD Hotel Dieu de Paris

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: ARCAGY/ GINECO GROUP Identifier: NCT00960336     History of Changes
Other Study ID Numbers: CDR0000633600
First Posted: August 17, 2009    Key Record Dates
Last Update Posted: October 29, 2014
Last Verified: October 2014
Keywords provided by ARCAGY/ GINECO GROUP:
HER2-negative breast cancer
recurrent breast cancer
stage IV breast cancer
invasive ductal breast carcinoma
invasive lobular breast carcinoma
Additional relevant MeSH terms:
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Topoisomerase Inhibitors
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action