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An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer

Phase 2
18 Years
85 Years
Not Enrolling
Breast Neoplasms

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Trial Information

An Open-Label Phase IIa Trial Evaluating the Safety and Efficacy of EPO906 as Therapy in Patients With Advanced Breast Cancer

Inclusion Criteria:

The following patients may be eligible for this study:

- Histologically or cytologically documented evidence of disease with at least one
measurable lesion;

- Life expectancy of greater than three (3) months;

- Patients who have had only one prior therapy for metastatic disease;

- Patients who have received prior treatment with hormonal agents or who have had prior
treatment regimens of radiotherapy in addition to one or no previous chemotherapy
regimens are eligible;

- Patients who have had no prior therapy for metastatic disease, but who have received
a taxane and an anthracycline (single or combination therapy) as adjuvant treatment,
are eligible. For patients who have had previous radiation therapy to the target
lesion(s), the lesion(s) must since have demonstrated progression.

Exclusion Criteria:

The following patients are not eligible for this study:

- Bone-only disease;

- Symptomatic pleural effusions;

- Symptomatic CNS metastases or leptomeningeal involvement;

- Any peripheral neuropathy or unresolved diarrhea greater than Grade 1;

- Severe cardiac insufficiency;

- Patients taking Coumadin or other warfarin-containing agents with the exception of
low dose Coumadin (1 mg or less) for the maintenance of in-dwelling lines or ports;

- History of another malignancy within 5 years prior to study entry except curatively
treated non-melanoma ckin cancer or cervical cancer in situ;

- Active or suspected acute or chronic uncontrolled infection including abcesses or

- HIV+ patients;

- Pregnant or lactating females;

- Patients who have had radiation, chemotherapy, or hormonal therapy within the last
four (4) weeks excluding palliative radiotherapy to isolated peripheral bone
metastases not being used as markers for efficacy;

- Patients taking Herceptin less than three (3) weeks prior to study start.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Tumor response as assessed by radiologic techniques and/or physical examination based on Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

Every 8 weeks

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Food and Drug Administration

Study ID:




Start Date:

January 2002

Completion Date:

Related Keywords:

  • Breast Neoplasms
  • breast
  • cancer
  • tumor
  • tumour
  • intravenous
  • epothilone
  • taxane
  • anthracycline
  • Breast Neoplasms
  • Neoplasms



Cancer Institute of New Jersey (CINJ) New Brunswick, New Jersey  08901
Dartmouth Hitchcock Medical Center Lebanon, New Hampshire  03756