Clinical Trial: Chemotherapy in Treating Patients With Breast Cancer

This study has been completed.

Sponsors and Collaborators: National Cancer Institute (NCI)
Kaplan Cancer Center
Information provided by: National Cancer Institute (NCI)


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.

Condition Treatment or Intervention Phase
stage IIIB breast cancer
Male Breast Cancer
stage IIIA breast cancer
stage IV breast cancer
recurrent breast cancer
 Drug: annamycin liposomal
Phase I
Phase II

MedlinePlus related topics:  Breast Cancer;   Male Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I/II Study of Annamycin Liposomal in Patients With Anthracycline-Resistant Locally Advanced or Metastatic Breast Cancer

Further Study Details: 

Study start: September 1998

OBJECTIVES: I. Determine the observed anti-tumor activity of annamycin liposomal in patients with anthracycline-resistant locally advanced or metastatic breast cancer. II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. III. Determine the clinical pharmacology of this regimen in these patients. IV. Determine the rationale for the dose and chosen schedule of this regimen in these patients.

PROTOCOL OUTLINE: Patients receive annamycin liposomal IV over 60 minutes on day 1. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-30 months.


Ages Eligible for Study:  18 Years and above



--Disease Characteristics--

  • Diagnosis of locally advanced or metastatic breast cancer
  • High likelihood of anthracycline resistance due to prior anthracycline exposure in the adjuvant or metastatic setting; Prior anthraquinone (e.g., mitoxantrone) insufficient; Prior cumulative anthracycline dose limited to doxorubicin-equivalent 350 mg/m2 by IV bolus or 450 mg/m2 by prolonged (at least 48 hours) infusion
  • Measurable or evaluable disease
  • Brain metastases treated by prior surgery and/or radiotherapy allowed if neurologic status stable 2 weeks after discontinuation of dexamethasone
  • Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

  • Biologic therapy: No concurrent prophylactic filgrastim (G-CSF)
  • Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) and recovered
  • Endocrine therapy: See Disease Characteristics
  • Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy and recovered
  • Surgery: See Disease Characteristics

--Patient Characteristics--

  • Age: 18 and over
  • Sex: Male or female
  • Menopausal status: Not specified
  • Performance status: Zubrod 0-2
  • Life expectancy: At least 12 weeks
  • Hematopoietic: Absolute granulocyte count greater than 1,500/mm3; Platelet count greater than 100,000/mm3
  • Hepatic: Bilirubin no greater than 1.5 mg/dL
  • Renal: Creatinine no greater than 1.5 mg/dL
  • Cardiovascular: No history of heart failure; Ejection fraction at least 55% by 2-dimensional echocardiogram
  • Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; Other prior malignancy allowed if curatively treated and there is clear diagnosis of metastatic breast cancer requiring treatment

Location Information

New York
      NYU School of Medicine's Kaplan Comprehensive Cancer Center, New York,  New York,  10016,  United States

Study chairs or principal investigators

Matthew D. Volm,  Study Chair,  Kaplan Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068486; NYU-9851; NCI-G01-1914
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  March 3, 2001 Identifier:  NCT00012129
Health Authority: United States: Federal Government processed this record on 2005-04-08

Cache Date: April 9, 2005