Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and cisplatin, also a highly active combination in this indication, may result in improvement in pathological response and overall survival. Patients with operable breast cancer will be treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine plus cisplatin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Cisplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Diagnosis of breast carcinoma

• No previous chemotherapy, with bidimensionally measurable locally advanced disease

• Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal to 70), bone marrow reserves, hepatic, cardiac and renal functions.

Exclusion Criteria:

• Inflammatory breast cancer

• Pregnancy and Breast-feeding

• Serious concomitant disorder or infection

• Previous cancer within the last 5 years or a second primary malignancy.