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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


Phase 2
70 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


OBJECTIVES:

Primary

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

Secondary

- 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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

PRIOR CONCURRENT THERAPY:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Response rate

Safety Issue:

No

Principal Investigator

Laure Chauvenet, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hotel Dieu de Paris

Authority:

United States: Federal Government

Study ID:

CDR0000633600

NCT ID:

NCT00960336

Start Date:

March 2008

Completion Date:

Related Keywords:

  • Breast Cancer
  • HER2-negative breast cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • invasive ductal breast carcinoma
  • invasive lobular breast carcinoma
  • Breast Neoplasms

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