Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer

June 18, 2013 updated by: Memorial Sloan Kettering Cancer Center

Phase I/II Study of TLC D-99 Plus Herceptin as First or Second Line Therapy for Patients With Locally Advanced Inflammatory or Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the safety, especially the cardiac safety, of doxorubicin HCl liposome and trastuzumab (Herceptin) as first- or second-line therapy in women with metastatic, inflammatory, or locally advanced breast cancer.

OUTLINE: Patients are stratified according to prior anthracycline therapy (yes vs no).

Patients receive doxorubicin HCl liposome IV over 1 hour followed 30 minutes later by trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, and 15. Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression.

Patients are followed for at least 3 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Maria Theodoulou, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1999

Primary Completion (ACTUAL)

August 1, 2003

Study Completion (ACTUAL)

August 1, 2003

Study Registration Dates

First Submitted

March 7, 2000

First Submitted That Met QC Criteria

May 13, 2003

First Posted (ESTIMATE)

May 14, 2003

Study Record Updates

Last Update Posted (ESTIMATE)

June 19, 2013

Last Update Submitted That Met QC Criteria

June 18, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 99-054
  • CDR0000067609 (REGISTRY: PDQ (Physician Data Query))
  • LIPO-D9905
  • NCI-G00-1684

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on trastuzumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Canada

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe