This trial is active, not recruiting.

Condition breast cancer
Treatment multi-beam intensity-modulated radiation therapy
Sponsor Memorial Sloan Kettering Cancer Center
Start date May 2010
End date May 2017
Trial size 120 participants
Trial identifier NCT01127373, 10-025


This study is being performed to understand the safety of a new radiation treatment called "Multi-Beam Intensity Modulated Radiation Therapy" ( IMRT). Currently, the standard way of giving radiation is with "simplified" IMRT, which uses only 2 beams of radiation. "Multi-beam" IMRT works by using 6-12 small radiation beams to give a more "tailored" or "customized" radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes.
multi-beam intensity-modulated radiation therapy BreastQ questionnaire- The BreastQ questionnaires have been developed by the
IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.

Primary Outcomes

To assess the feasibility of adjuvant radiation therapy via multi-beam IMRT using daily 3D position verification
time frame: 5 weeks

Secondary Outcomes

To evaluate the rate and severity of both acute and late cutaneous toxicity
time frame: 5-7 months following the completion of radiation therapy
To evaluate the rate and severity of late subcutaneous fibrosis
time frame: 5-7 months following the completion of radiation therapy
To evaluate the rate and severity of radiation pneumonitis (RP)
time frame: 5-7 months following the completion of radiation therapy
To evaluate local-regional control rates
time frame: 5-7 months following the completion of radiation therapy
To evaluate patient set-up reproducibility in breast cancer patients treated with multi-beam IMRT
time frame: 5-7 months following the completion of radiation therapy

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female gender - Age ≥18 years - An invasive primary breast cancer of any histology arising from breast parenchyma - Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection - Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is ≥1 and M stage is 0. - Patient signed study-specific consent form. Exclusion Criteria: - Patients with distant metastasis. - Patients who are pregnant or breastfeeding. - Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. - Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months. - Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist. - Prior radiation therapy to the ipsilateral or contralateral breast or thorax. - Primary breast cancer is a lymphoma or sarcoma histology. - Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer. - Patients requiring radiation to the bilateral breasts.

Additional Information

Official title Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes
Principal investigator Alice Ho, MD
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.