Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer (eLEcTRA)

Novartis

Status and phase: Terminated; Phase 4

Conditions: Metastatic Breast Cancer

Treatments: Drug: Trastuzumab plus Letrozole; Drug: Letrozole

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT00171847

CFEM345C2403

Details and patient eligibility

About

Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients

Enrollment: 93 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal
• Her-2 overexpression and ER and/or PgR positive
• Metastatic Breast Cancer

Exclusion criteria

• Previous treatment with trastuzumab
• Significant Liver or renal impairment
• Erbb2 negative and/or ER and PgR negative

Other protocol-defined inclusion / exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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93 participants in 3 patient groups

A - HER-2 +ve patients with Femara alone

Experimental group

Treatment:

Drug: Letrozole

Drug: Letrozole

B - HER-2 +ve patients with Femara + Herceptin

Experimental group

Treatment:

Drug: Trastuzumab plus Letrozole

C - HER-2 -ve patients with Femara alone

Experimental group

Treatment:

Drug: Letrozole

Drug: Letrozole