Phase III Study of Two Different Schedules (Weekly and Tri-weekly) of Combination of Gemcitabine and Two Taxanes in MBC

Lilly

Status and phase: Completed; Phase 3

Conditions: Metastatic Breast Cancer (MBC)

Treatments: Drug: Paclitaxel; Drug: Docetaxel; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00236899

B9E-IT-S376 (Other Identifier)

9846

Details and patient eligibility

About

Multi-center, randomized Phase III study. 4 arms. 360 Patient to enroll. Purpose is evaluate time to progression disease (PD).

Enrollment: 241 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologic diagnosis of metastatic breast cancer (MBC).
• Prior neoadjuvant or adjuvant taxanes regimen is allowed if ≥12 months since completion of the regimen.
• Relapsing after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline if not clinically contraindicated.
• Patients with measurable disease.
• Previous hormonal therapy for adjuvant setting or metastatic disease.

Exclusion criteria

• Previous chemotherapy for MBC
• Previous chemotherapy with gemcitabine in any setting of disease
• Patient candidable to treatment with trastuzumab.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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241 participants in 4 patient groups

A: Docetaxel and Gemcitabine (Tri-weekly)

Experimental group

Description:

Docetaxel and Gemcitabine (Tri-weekly)

Treatment:

Drug: Docetaxel

Drug: Gemcitabine

B: Paclitaxel and Gemcitabine (Tri-weekly)

Experimental group

Description:

Paclitaxel and Gemcitabine (Tri-weekly)

Treatment:

Drug: Paclitaxel

Drug: Gemcitabine

C: Docetaxel and Gemcitabine (Weekly)

Experimental group

Description:

Docetaxel and Gemcitabine (Weekly)

Treatment:

Drug: Docetaxel

Drug: Gemcitabine

D: Paclitaxel and Gemcitabine (Weekly)

Experimental group

Description:

Paclitaxel and Gemcitabine (Weekly)

Treatment:

Drug: Paclitaxel

Drug: Gemcitabine