NCT00960336

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

3.2 years

First QC Date

August 14, 2009

Last Update Submit

October 28, 2014

Conditions

Breast Cancer

Keywords

HER2-negative breast cancerrecurrent breast cancerstage IV breast cancerinvasive ductal breast carcinomainvasive lobular breast carcinoma

Outcome Measures

Primary Outcomes (1)

  • Response rate

    3 and 6 cures

Study Arms (1)

single arm

EXPERIMENTAL
Drug: pegylated liposomal doxorubicin hydrochloride

Interventions

pegylated liposomal doxorubicin hydrochlorideDRUG
single arm

Eligibility Criteria

Age70 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de Paris

Paris, 75181, France

Location

Related Publications (1)

  • Falandry C, Brain E, Bonnefoy M, Mefti F, Jovenin N, Rigal O, Guillem O, El Kouri C, Uwer L, Abadie-Lacourtoisie S, Cretin J, Jacquin JP, Paraiso D, Freyer G. Impact of geriatric risk factors on pegylated liposomal doxorubicin tolerance and efficacy in elderly metastatic breast cancer patients: final results of the DOGMES multicentre GINECO trial. Eur J Cancer. 2013 Sep;49(13):2806-14. doi: 10.1016/j.ejca.2013.04.027. Epub 2013 Jun 1.

    PMID: 23735702DERIVED

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Ductal, BreastCarcinoma, Lobular

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesCarcinoma, DuctalAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Laure Chauvenet, MD

    Hotel Dieu de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

March 1, 2008

Primary Completion

May 1, 2011

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

FR(1)