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

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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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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