NCT00004925

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase I/II trial to study the effectiveness of liposomal doxorubicin and trastuzumab in treating women who have locally advanced, inflammatory, or metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Aug 1999

Typical duration for phase_1 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

August 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2000

Completed
3.2 years until next milestone

First Posted

Study publicly available on registry

May 14, 2003

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
Last Updated

June 19, 2013

Status Verified

June 1, 2013

Enrollment Period

4 years

First QC Date

March 7, 2000

Last Update Submit

June 18, 2013

Conditions

Breast Cancer

Keywords

stage IV breast cancerrecurrent breast cancerstage IIIB breast cancerinflammatory breast cancer

Interventions

trastuzumabBIOLOGICAL
pegylated liposomal doxorubicin hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed locally advanced, inflammatory, or metastatic adenocarcinoma of the breast that has been treated with no more than 1 prior systemic cytotoxic regimen * Overexpression of HER2 protein (2+ or 3+) * Evaluable disease * History of brain metastases allowed if off steroids and asymptomatic, with a 3 month or greater interval since last dose of brain irradiation, and no evidence of progression * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 18 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.5 times upper limit of normal (ULN) Renal: * AST or ALT no greater than 4 times ULN Cardiovascular: * Adequate cardiac function * LVEF at least 50% predicted or lower limit of normal Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent medical or psychological condition that would preclude study compliance * No history of hypersensitivity to anthracyclines, eggs, or egg products PRIOR CONCURRENT THERAPY: Biologic therapy: * Prior trastuzumab (Herceptin) allowed Chemotherapy: * See Disease Characteristics * At least 3 weeks since prior antineoplastic therapy * No more than 1 prior systemic cytotoxic regimen for locally advanced, metastatic, or inflammatory breast cancer * No prior anthracyclines greater than 240 mg/m2 * No other concurrent antineoplastic agents * No concurrent treatment with other liposomal products other than doxorubicin HCl liposome Endocrine therapy: * See Disease Characteristics * At least 3 weeks since prior hormonal agents * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics Surgery: * Not specified Other: * At least 3 weeks since other prior investigational drugs

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

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (1)

  • Theodoulou M, Batist G, Campos S, Winer E, Welles L, Hudis C. Phase I study of nonpegylated liposomal doxorubicin plus trastuzumab in patients with HER2-positive breast cancer. Clin Breast Cancer. 2009 May;9(2):101-7. doi: 10.3816/CBC.2009.n.019.

    PMID: 19433391RESULT

MeSH Terms

Conditions

Breast NeoplasmsInflammatory Breast Neoplasms

Interventions

Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Maria Theodoulou, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 7, 2000

First Posted

May 14, 2003

Study Start

August 1, 1999

Primary Completion

August 1, 2003

Study Completion

August 1, 2003

Last Updated

June 19, 2013

Record last verified: 2013-06

Locations

US(1)