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Trastuzumab and Radiation Therapy in Treating Women With Stage III or Stage IV Invasive Primary Cancer of the Breast

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006109
  Purpose

RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with radiation therapy may be an effective treatment for breast cancer.

PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab and radiation therapy in treating women who have stage III or stage IV invasive primary cancer of the breast.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab
Procedure: radiation therapy
Phase II

Genetics Home Reference related topics:   breast cancer   

MedlinePlus related topics:   Breast Cancer    Cancer   

Drug Information available for:   Trastuzumab   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   Phase II Trial of Herceptin Concurrent With External Beam Radiation Following Neoadjuvant Chemotherapy for the Treatment of HER2 Over-Expressing Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   March 2000

Detailed Description:

OBJECTIVES: I. Determine the tolerability of trastuzumab (Herceptin) and radiotherapy in women with stage III or IV invasive primary carcinoma of the breast that continues to overexpress HER2 following neoadjuvant systemic chemotherapy. II. Determine the pathologic response rate, locoregional recurrence rate, and time to locoregional recurrence in patients treated with this regimen who did not achieve clinical complete remission following neoadjuvant systemic chemotherapy.

OUTLINE: Patients who received trastuzumab (Herceptin) in combination with prior neoadjuvant chemotherapy receive trastuzumab IV over 30 minutes on day 1, followed by radiotherapy on days 1-5. Patients who did not receive trastuzumab in combination with prior neoadjuvant chemotherapy receive a loading dose of trastuzumab IV over 90 minutes, followed one week later by trastuzumab IV over 30 minutes on day 1, followed by radiotherapy on days 1-5. Radiotherapy begins within 3-4 weeks after completion of neoadjuvant chemotherapy. Treatment continues weekly for 5 courses in the absence of unacceptable toxicity. Patients are followed at 3 weeks for surgical resectability, then every 3 months for 2 years, and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Criteria

DISEASE CHARACTERISTICS: Histologically proven invasive primary carcinoma of the breast by fine needle aspiration cytology, core needle biopsy, or incisional biopsy No prior excisional biopsy Stage III or IV disease, including the following: Any T with N2 or N3 Inflammatory breast cancer or otherwise inoperable T4 Supraclavicular/infraclavicular adenopathy Distant metastasis with measurable disease in the breast or lymph nodes Must have received neoadjuvant systemic chemotherapy with or without trastuzumab (Herceptin) within the past 4 weeks and have residual tumor that continues to overexpress HER2 Measurable or evaluable locoregional disease after completion of neoadjuvant chemotherapy Synchronous bilateral primary carcinoma of the breast allowed if the more serious of the 2 carcinomas meets the above staging criteria Candidate for locoregional therapy consisting of radiotherapy followed by surgery Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: Over 18 Sex: Female Menopausal status: Any status Performance status: Not specified Life expectancy: Not specified Hematopoietic: WBC greater than 3,000/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 12 g/dL Hepatic: Not specified Renal: Not specified Cardiovascular: Left ventricular ejection fraction normal by radionuclide ventriculography Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics No prior radiotherapy to breast or regional lymph nodes Surgery: See Disease Characteristics

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006109

Locations
United States, North Carolina
Lineberger Comprehensive Cancer Center, UNC    
      Chapel Hill, North Carolina, United States, 27599-7295

Sponsors and Collaborators
UNC Lineberger Comprehensive Cancer Center
National Cancer Institute (NCI)

Investigators
Study Chair:     Carolyn Sartor, MD     UNC Lineberger Comprehensive Cancer Center    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000068120, UNC-9925, NCI-G00-1835
First Received:   August 3, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006109
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer  
stage IIIA breast cancer  
recurrent breast cancer  
stage IIIB breast cancer  
inflammatory breast cancer  

Study placed in the following topic categories:
Inflammatory breast cancer
Skin Diseases
Trastuzumab
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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