Status:
ACTIVE_NOT_RECRUITING
Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Anatomic Stage II Breast Cancer AJCC v8
Anatomic Stage IIA Breast Cancer AJCC v8
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This phase II trial studies the shoulder morbidity in patients with lymph-node positive breast cancer receiving intensity modulated radiation therapy or 3-dimensional conformal radiation therapy. Inte...
Detailed Description
PRIMARY OBJECTIVES: I. To determine if intensity modulated radiation therapy (IMRT) reduces average 1-year patient-reported shoulder/arm morbidity in women receiving regional nodal irradiation (RNI) ...
Eligibility Criteria
Inclusion
- Pathologically proven diagnosis of breast cancer
- Patients that receive neoadjuvant systemic therapy (chemotherapy, anti-HER2 therapy, or endocrine therapy) are eligible
- History/physical examination within 60 days prior to study entry
- Patients who have undergone either a lumpectomy or mastectomy are eligible
- Patients that have undergone any type of breast reconstruction are eligible
- The interval between the date of last surgery or chemotherapy and registration must be =\< 84 days
- Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of start of radiation therapy
- Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy
- Patients must provide study specific informed consent prior to study entry
Exclusion
- Clinical or radiologic evidence of distant metastases
- Patients with known unresected disease in the axillary apex or supraclavicular fossa
- Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ \[LCIS\] is eligible)
- Prior surgery to the ipsilateral shoulder for any condition
- Baseline impaired mobility of the ipsilateral shoulder from a condition not related to the breast cancer surgery as determined by the treating physician
- Non-epithelial breast malignancies such as sarcoma/lymphoma
- Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields
- Medical, psychiatric, or other conditions that would prevent the patient from receiving the protocol therapy or providing informed consent
- Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
- Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
Key Trial Info
Start Date :
January 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03786354
Start Date
January 9 2019
End Date
December 31 2025
Last Update
July 10 2025
Active Locations (1)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210