Breast Cancer
Conditions
Keywords
ductal breast carcinoma in situ, invasive ductal breast carcinoma, breast cancer in situ, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief summary
RATIONALE: Diagnostic procedures, such as multifunctional magnetic resonance imaging and CT scans, may help reduce normal tissue damage in patients undergoing radiation therapy for cancer. PURPOSE: This clinical trial is studying how well radiation therapy planning techniques work in reducing damage to normal tissue in women undergoing breast-conserving surgery for ductal breast carcinoma.
Detailed description
OBJECTIVES: * To improve precision of tumor bed localization and definition of clinical target volume, and to reduce normal tissue irradiation in women undergoing partial breast or breast boost radiotherapy. * To test whether post-operative MRI improves the precision of tumor bed delineation after wide-local excision in comparison with the current standard CT scan/clip method. * To determine the impact of tumor position within the excision specimen upon the localization of clinical target volume in relation to the tumor bed. * To compare theoretical non-target tissue exposure from partial breast irradiation planned in the supine and prone (face-down) positions. OUTLINE: Patients undergo planned breast-conservation surgery and placement of titanium clips to the four radial, the deep, and superficial margins of the excision cavity (for localization of tumor bed). Within 2 weeks after surgery, patients undergo supine radiotherapy-planning CT scan as standard analysis. Patients then undergo a radiotherapy-planning CT scan in the prone position. Patients complete a linear analogue questionnaire after both scans designed to assess patient comfort and anxiety in each position. Patients then undergo multifunctional MRI (including dynamic contrast-enhancement MRI and diffusion-weighted MRI) of the ipsilateral breast in the prone position (≥ 3 weeks after surgery). If suspicious lesions ≥ 5 mm are found on MRI, patients are referred for a second-look ultrasound with biopsy (if lesion visible on ultrasound); where suspicious lesions are seen only on MRI, patients undergo MRI-guided biopsy. Lesions \< 5 mm are included in the whole-breast radiotherapy treatment.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
DISEASE CHARACTERISTICS: * Planning to undergo breast-conserving surgery (BCS)\* for unifocal ductal carcinoma in situ (DCIS) or grade 1-2 invasive ductal carcinoma (IDC) of the breast NOTE: \*Patients who have underwent BCS and have titanium clips placed according to this protocol are eligible for this study. * No T4d or multifocal disease (as defined on mammography or ultrasound) * No G3 disease * Hormone receptor status not specified PATIENT CHARACTERISTICS: Inclusion criteria: * Female * Menopausal status not specified
Exclusion criteria
* Cup size DD or greater * Ferromagnetic implants (exclude participation in MRI) * Claustrophobia (exclude participation in MRI) * Gadolinium allergy PRIOR CONCURRENT THERAPY: * No prior surgery to ipsilateral breast * No prior neoadjuvant chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in lung NTDmean (biologically weighted [normalized] mean of total dose to lung normalized to 2 Gy fractions) in supine vs prone positions | — |
Secondary
| Measure | Time frame |
|---|---|
| Closeness of agreement between clinical target volumes (CTVs) defined using uniform margin vs those defined using knowledge of all excision margins | — |
| Difference in NTDmean to ipsilateral non-planning target volume (PTV) breast tissue, chest wall muscle, and heart | — |
| Difference in mean volume of PTV in supine versus prone positions | — |
| Closeness of agreement between MRI-based vs CT scan/clip- based delineation of tumor bed | — |
| Difference in complexity of beams needed to achieve above dose homogeneity within PTV | — |
| Patient comfort with each positioning technique (assessed by questionnaire) | — |
| Difference in dose homogeneity within PTV in each position | — |
Countries
United Kingdom