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A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer


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

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Trial Information

A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer


Inclusion Criteria:



- Diagnosis of locally advanced or metastatic breast cancer not amenable to local
treatment.

- Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.

- Patients must have at least one measurable lesion in an area not previously
irradiated.

- No chemotherapy at least 4 weeks prior to study enrollment.

- Signed informed consent from patient.

Exclusion Criteria:

- Treatment with any drug within the last 30 days that has not received regulatory
approval.

- Serious systemic disorders, including active infection.

- Significant cardiovascular disease.

- Pregnancy or breast feeding.

- Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Authority:

United States: Food and Drug Administration

Study ID:

4028

NCT ID:

NCT00097383

Start Date:

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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