Clinical trial · Interventional
Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer
Prospective Evaluation of Shoulder Morbidity in Patients With Lymph-Node Positive Breast Cancer Receiving Regional Nodal Irradiation
NCT03786354CI-TRIAL-00105950active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. Intensity modulated radiation therapy may cause less shoulder/arm morbidity in patients with lymph-node positive breast cancer.
Conditions
Conditions (15)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage III Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIC Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Lymph Node Involvement | — | UNRESOLVED | — |
| Prognostic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IIB Breast Cancer AJCC v8 | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3-Dimensional Conformal Radiation Therapy | Radiation | — | UNRESOLVED |
| Intensity-Modulated Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (IMRT)
- description
- Patients undergo Intensity-Modulated Radiation Therapy over 5 weeks.
- interventionNames
- Radiation: Intensity-Modulated Radiation Therapy
- type
- EXPERIMENTAL
- label
- Arm B (3DCRT)
- description
- Patients undergo 3-Dimensional Conformal Radiation Therapy over 5 weeks.
- interventionNames
- Radiation: 3-Dimensional Conformal Radiation Therapy
Primary outcomes (1)
- measure
- Shoulder/arm morbidity assessed by Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire in patients treated with intensity modulated radiation therapy (IMRT)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.