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

Sponsor:	UNC Lineberger Comprehensive Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00943410

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Biological: trastuzumab Radiation: external beam radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Primary Purpose: 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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Trastuzumab

U.S. FDA Resources

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

Primary Outcome Measures:

Toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pathologic response rate [ Designated as safety issue: No ]
Locoregional recurrence rate [ Designated as safety issue: No ]
Time to locoregional recurrence [ Designated as safety issue: No ]
Time to local progression (in patients who are deemed to be non-surgical candidates) [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	March 2000
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam radiotherapy in women with HER2-overexpressing stage III or IV breast cancer.

Secondary

Determine the pathologic response rate in patients treated with this regimen.
Determine the locoregional recurrence rate (as site of first recurrence or any recurrence) and time to locoregional recurrence in patients treated with this regimen.
Determine the time to local progression in patients (who are deemed to be non-surgical candidates) treated with this regimen .

OUTLINE: This is a multicenter study.

Patients receive trastuzumab IV over 30-90 minutes once a week for 5 weeks. Patients also undergo external beam radiotherapy once daily 5 days a week for 5 weeks.

Three weeks after the completion of trastuzumab and radiotherapy, patients undergo surgical evaluation. Patients deemed to be surgical candidates undergo surgery. Patients deemed to be non-surgical candidates continue to receive trastuzumab and external beam radiotherapy for 2 additional weeks.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed* invasive primary carcinoma of the breast by fine-needle aspiration, core needle biopsy, or incisional biopsy
Excisional biopsy is not allowed
Stage III or IV disease (clinical and radiographic staging), including any of the following:
- Any T with N2 disease (metastasis to ipsilateral axillary lymph nodes fixed to one another or other structures) or N3 disease (metastasis to ipsilateral internal mammary lymph nodes)
- T4, any N disease
- Inflammatory disease
- Supraclavicular and/or infraclavicular adenopathy
- Distant metastasis with measurable disease in the breast or lymph nodes
HER2-overexpressing tumor
Measurable or evaluable disease
Residual locoregional disease after completion of neoadjuvant chemotherapy OR locoregional recurrent disease
Synchronous bilateral primary cancers allowed provided the more serious of the two cancers meets staging criteria
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Menopausal status not specified
WBC > 2,000/mm^3
Platelet count > 50,000/mm^3
Hemoglobin > 11 g/dL
Negative pregnancy test
Fertile patients must use effective contraception
Radionucleotide ventriculography/LVEF normal OR ≤ 10% asymptomatic decline from baseline after completion of neoadjuvant chemotherapy

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior radiotherapy to the breast or regional lymph nodes
Concurrent participation in neoadjuvant chemotherapy clinical trials allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943410

Sponsors and Collaborators

UNC Lineberger Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Carolyn Sartor, MD

UNC Lineberger Comprehensive Cancer Center

More Information

Additional Information:

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

No publications provided

Responsible Party:	Carolyn Sartor, Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
ClinicalTrials.gov Identifier:	NCT00943410 History of Changes
Obsolete Identifiers:	NCT00006109
Other Study ID Numbers:	CDR0000649128, UNC-LCCC9925
Study First Received:	July 21, 2009
Last Updated:	August 4, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

HER2-positive breast cancer
inflammatory breast cancer
recurrent breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012