Trials Sponsors Conditions Drugs Pricing

Conditions

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

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

Sponsors & Collaborators

ARCAGY/ GINECO GROUP
Otherlead

Study Sites (1)

Hotel Dieu de Paris

Paris, 75181, France

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

Enrollment

59 participants (actual enrollment reported by the registry).

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 2008

Date type not reported

This date has not been verified as actual or estimated.

Doxorubicin Hydrochloride Liposome as First-Line Therapy in Treating Older Women With Metastatic Breast Cancer

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

single arm

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

single arm

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations