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

An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171847

Acronym

eLEcTRA

Enrollment

Registered

2005-09-15

Start date

2003-03-31

Completion date

Unknown

Last updated

2010-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer

Keywords

Breast cancer, Metastatic, Trastuzumab, Letrozole

Brief summary

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

Interventions

DRUGLetrozole

DRUGTrastuzumab plus Letrozole

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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 /

Design outcomes

Primary

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

Secondary

Measure	Time frame
Objective response rate/Clinical Benefit rate	3 months
Time to treatment failure	3 months
Duration of response/clinical benefit during treatment	3 months
Overall survival	3 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026