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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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Maria Theodoulou, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Federal Government

Study ID:

99-054

NCT ID:

NCT00004925

Start Date:

August 1999

Completion Date:

August 2003

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
  • inflammatory breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021