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

Phase 4TerminatedNCT00171847

Novartis Pharmaceuticals93 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Breast Cancer

Interventions

LetrozoleDRUG

Trastuzumab plus LetrozoleDRUG

LetrozoleDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Novartis Investigative Site

Tübingen, Germany

Outcomes

Primary Outcomes

Time to progression as assessed by clinical palpation and radiologic imaging every 3 months

Time frame: 3 months

Secondary Outcomes

Objective response rate/Clinical Benefit rate

Time frame: 3 months

Time to treatment failure

Time frame: 3 months

Duration of response/clinical benefit during treatment

Time frame: 3 months

Overall survival

Time frame: 3 months

Data from ClinicalTrials.gov

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