Adjuvant Epirubicin/Cytoxan Followed By A Taxane VS. Epirubicin/Taxane As Treatment For Node-Positive Breast Cancer

Pfizer

Status and phase: Completed; Phase 3

Conditions: Adenocarcinoma

Treatments: Drug: Epirubicin with a Taxane; Drug: Epirubicin with Cyclophosphamide, followed by a Taxane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00140075

378-ONC-0030-184

Details and patient eligibility

About

The purpose of this study is to compare two combinations of drugs, epirubicin given with a taxane (ET) or epirubicin given with cyclophosphamide (cytoxan) and followed by a taxane to see if one of the combinations is better at preventing or delaying the time for breast cancer recurrence and death after 3 years. The study will also evaluate the side effects of both treatment combinations.

Enrollment: 606 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Breast Cancer Stage T1-3, N1, M0
• Suitable candidate for anthracycline-containing adjuvant chemotherapy

Exclusion criteria

• Evidence of residual tumor following surgery, or metastatic disease
• Received prior therapy for breast cancer

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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606 participants in 2 patient groups

B

Experimental group

Description:

ET (8 cycles) T = docetaxel or paclitaxel

Treatment:

Drug: Epirubicin with a Taxane

A

Experimental group

Description:

EC (4 cycles) followed by T (4 cycles) for a total of 8 cycles T = docetaxel or paclitaxel

Treatment:

Drug: Epirubicin with Cyclophosphamide, followed by a Taxane