Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: surgery; Drug: gemcitabine; Drug: cisplatin; Drug: doxorubicin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191789

B9E-MC-S329 (Other Identifier)

7117

Details and patient eligibility

About

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.

Enrollment: 65 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Gemcitabine+Doxorubicin+Cisplatin+Surgery

Experimental group

Description:

Gemcitabine: 1200 mg/m\^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m\^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8). Doxorubicin: 60 mg/m\^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m\^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.

Treatment:

Procedure: surgery

Drug: cisplatin

Drug: doxorubicin

Drug: gemcitabine