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Trastuzumab and External Beam Radiation Therapy in Treating Women With Stage III or Stage IV Breast Cancer

NCT00943410 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2012-08-15

No results posted yet for this study

Summary

RATIONALE: 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Trastuzumab may make tumor cells more sensitive to radiation therapy. Giving trastuzumab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving trastuzumab together with external beam radiation therapy works in treating women with stage III or stage IV breast cancer.

Conditions

Interventions

RADIATION

external beam radiation therapy

Radiation therapy will consist of 50Gy in 2Gy fractions to the breast/chest wall and regional lymphatics for 5 consecutive days up to 5 weeks for surgical candidates and 7 weeks for non-surgical candidates

DRUG

Herceptin

Patients who are already receiving weekly Herceptin® will continue weekly Herceptin®, 2mg/kg IV on day 1 of each week of radiotherapy. Patients who have not been receiving weekly Herceptin® as a component of systemic therapy will begin Herceptin® one week prior to beginning radiotherapy with a loading dose of 4mg/kg followed by weekly Herceptin® at 2mg/kg on day 1 of each week of radiotherapy

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Carolyn Sartor, MD · UNC Lineberger Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Primary Completion
2006-01-31
Completion
2009-07-31

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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 NCT00943410 on ClinicalTrials.gov