Clinical trial · Interventional
Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Unable to recruit further patients.
Summary
Brief summary (as posted)
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.
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 |
|---|---|---|---|
| brachytherapy | Radiation | — | UNRESOLVED |
| Lumpectomy | Procedure | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lumpectomy with Brachytherapy
- description
- Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
- interventionNames
- Drug: Tamoxifen
- Procedure: Lumpectomy
- Radiation: brachytherapy
Primary outcomes (2)
- measure
- Number of Patients With Ipsilateral Breast Tumor Recurrence
- timeFrame
- 1 year after treatment
- description
- Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy * Size: \< 3 cm on mammogram * Unicentric disease * Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy * Patient Age: ≥ 18 years, no upper limit * Life expectancy \> 5 years Exclusion Criteria: * Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix * Pregnant or breast feeding * Multicentric disease * Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis
References
Publications (0)
Data not yet available