Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

Lilly

Status and phase: Completed; Phase 2

Conditions: Metastatic Breast Cancer

Treatments: Drug: gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191269

B9E-JE-MB21 (Other Identifier)

9065

Details and patient eligibility

About

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer

Enrollment: 68 patients

Sex: Female

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically and/or cytologically confirmed breast cancer
• Received prior chemotherapy for metastatic breast cancer with anthracycline and taxane regimen
• To have at least one measurable region
• PS: 0-1
• To have adequate organ function (bone marrow, liver and renal function)

Exclusion criteria

• To have Interstitial pneumonia or pulmonary fibrosis
• To have inflammatory carcinoma
• Within 28 days after the latest chemotherapy or radiotherapy, 14 days after the latest hormonal/immunotherapy or 7 days after surgery
• To have brain metastasis with symptom
• To have severe complication (cardiac infarction, infection, drug hyper sensitivity or diabetes)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

A

Experimental group

Description:

Dose Level 1 - 1000 mg/m2

Treatment:

Drug: gemcitabine

Drug: gemcitabine

B

Experimental group

Description:

Dose Level 2 - 1250 mg/m2

Treatment:

Drug: gemcitabine

Drug: gemcitabine