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

NCT ID: NCT00171847

Last Updated: 2010-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-03-31

Brief Summary

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

Detailed Description

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Conditions

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Metastatic Breast Cancer

Keywords

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Breast cancer Metastatic Trastuzumab Letrozole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A - HER-2 +ve patients with Femara alone

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Trastuzumab plus Letrozole

Intervention Type DRUG

C - HER-2 -ve patients with Femara alone

Group Type EXPERIMENTAL

Letrozole

Intervention Type DRUG

Interventions

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Letrozole

Intervention Type DRUG

Trastuzumab plus Letrozole

Intervention Type DRUG

Letrozole

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Roche - Prof. Dr. Jens Huober et al.

UNKNOWN

Sponsor Role collaborator

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Novartis Pharmaceuticals

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmeceuticals

Locations

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Novartis Investigative Site

Tübingen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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CFEM345C2403

Identifier Type: -

Identifier Source: org_study_id