Trastuzumab and External Beam Radiation Therapy in Treating Women With Stage III or Stage IV Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Radiation: external beam radiation therapy
- Registration Number
- NCT00943410
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Surgical Candidate external beam radiation therapy After 5 consecutive weeks of treatment with Radiation and Herceptin, these subjects will receive mastectomy excision Surgical Candidate Herceptin After 5 consecutive weeks of treatment with Radiation and Herceptin, these subjects will receive mastectomy excision Non-Surgical Candidate external beam radiation therapy After 5 weeks of consecutive treatment with radiation and herceptin, these subjects will not be eligible for surgery. They will continue with radiation and herceptin for an additional 2 weeks. Non-Surgical Candidate Herceptin After 5 weeks of consecutive treatment with radiation and herceptin, these subjects will not be eligible for surgery. They will continue with radiation and herceptin for an additional 2 weeks.
- Primary Outcome Measures
Name Time Method Number of subjects experiencing adverse events 7 weeks Toxicity (adverse events) will be measured and graded using the CTCAE criteria. RTOG acute toxicity criteria will be used to score acute radiation-related toxicity
- Secondary Outcome Measures
Name Time Method Pathologic response rate 5 weeks Pathological response will be measured for those subjects who are deemed surgical candidates. Pathologic response will be defined as invasive tumor present pathologically, or complete invasive tumor clearance (pCR), which includes those tumors with no tumor present as well as those tumors with only in situ carcinoma present after all therapy
Locoregional recurrence rate up to 5 years Radiographic response and recurrence rate will captured using RECIST criteria. Subjects will be followed up for 5 years to document recurrence.
Time to locoregional recurrence Up to 5 years Radiographic response and recurrence rate will captured using RECIST criteria. Subjects will be followed up to 5 years to document recurrence
Time to local progression (in patients who are deemed to be non-surgical candidates) Up to 5 years Radiographic response and recurrence rate will captured using RECIST criteria. Disease progression is defined as an increase in the product of two perpendicular diameters of any measured lesion by \> 25% over the size at study entry or the appearance of new areas of malignant disease