Clinical trial · Interventional
Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
A Single Institution, Prospective, Non-randomized Study of Partial Breast Irradiation Using the MammoSite Radiation Therapy System (Breast Brachytherapy Applicator)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): funding issues and Principal Investigator leaving the institution
Summary
Brief summary (as posted)
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| accelerated partial breast irradiation | Radiation | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| intracavitary balloon brachytherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Proportion of local recurrence
- timeFrame
- up to 5 years
- description
- * Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume. * Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.
Secondary outcomes (2)
- measure
- Safety and toxicity
- timeFrame
- up to 30 months after radiotherapy
- measure
- Cosmetic results
- timeFrame
- up to 30 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma
* Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease
* Pathologic staging of the axilla preferred
* Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors
* Unicentric tumor
* Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm
* Must have undergone lumpectomy as definitive surgery
* Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery
* Re-excision to obtain negative margins allowed
* Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm)
* No multicentric carcinoma (invasive or DCIS) in more than one quadrant
* No clinically or pathologically positive regional lymph nodes
* No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing \> 25% of the primary tumor
* Hormone receptor status not specified
PATIENT CHARACTERISTICS:
* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No collagen-vascular disease, including any of the following:
* Dermatomyositis
* Systemic lupus erythematosus
* Scleroderma-mixed connective tissue disease
PRIOR CONCURRENT THERAPY:
* See Disease CharacteristicsReferences
Publications (0)
Data not yet available