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Fulvestrant and/or Trastuzumab as First-Line Therapy in Treating Postmenopausal Women With Stage IV Breast Cancer

NCT00138125 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-10-19

Study results available
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Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant may fight breast cancer by lowering the amount of estrogen the body makes. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving fulvestrant together with trastuzumab is more effective than giving fulvestrant or trastuzumab alone in treating breast cancer.

PURPOSE: This randomized phase II trial is studying how well fulvestrant and/or trastuzumab works as first-line therapy in treating postmenopausal women with stage IV breast cancer.

Conditions

Interventions

DRUG

Faslodex

Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.

BIOLOGICAL

Herceptin

Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly

Sponsors & Collaborators

Principal Investigators

  • Richard J. Pietras, MD, PhD · Jonsson Comprehensive Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2009-09-30
Completion
2009-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00138125 on ClinicalTrials.gov