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Fulvestrant With or Without Lapatinib and/or Aromatase Inhibitor Therapy in Treating Postmenopausal Women With Metastatic Breast Cancer That Progressed After Previous Aromatase Inhibitor Therapy

NCT00688194 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2013-08-26

No results posted yet for this study

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant and exemestane, anastrozole, or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells and by lowering the amount of estrogen the body makes. Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether fulvestrant is more effective with or without lapatinib and/or aromatase inhibitor therapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying fulvestrant with or without lapatinib and/or aromatase inhibitor therapy to compare how well they work in treating postmenopausal women with metastatic breast cancer that progressed after previous aromatase inhibitor therapy.

Conditions

Interventions

DRUG

anastrozole

Patients receive aromatase inhibitor therapy according to standard treatment regulations.

DRUG

exemestane

Patients receive aromatase inhibitor therapy according to standard treatment regulations.

DRUG

fulvestrant

Given intramuscularly

DRUG

lapatinib ditosylate

Given orally

DRUG

letrozole

Patients receive aromatase inhibitor therapy according to standard treatment regulations.

OTHER

placebo

Given orally

Sponsors & Collaborators

  • Gruppo Italiano Mammella (GIM)

    lead OTHER

Principal Investigators

  • Sabino De Placido, MD · Federico II University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2013-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00688194 on ClinicalTrials.gov