Clinical trial · Interventional
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
TRI-fraction Radiotherapy Utilized to Minimize Patient Hospital Trips : A Phase II Trial (TRIUMPH-T Trial)
NCT02526498CI-TRIAL-00066412TRIUMPH-TcompletedPhase 2Results postedClinicalTrials.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 how well accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy works in treating patients with breast cancer that has not spread beyond the breast or the axillary lymph nodes (early-stage) after surgery. Radiation therapy uses a type of energy to kill cancer cells and shrink tumors. Brachytherapy is a type of internal radiation therapy that provides radiation inside the breast to any remaining tumor cells next to the space where the tumor was removed, and is given over a shorter amount of time than standard radiation therapy. Giving accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy may reduce the overall time that radiation is delivered to the tumor cells.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Progesterone Receptor Positive | — | UNRESOLVED | — |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated Partial Breast Irradiation | Radiation | — | UNRESOLVED |
| High-Dose Rate Brachytherapy | Radiation | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (APBI using HDR brachytherapy)
- description
- Within 1-5 days after balloon placement, patients undergo APBI using HDR brachytherapy over 15-60 minutes for 2-3 days.
- interventionNames
- Radiation: Accelerated Partial Breast Irradiation
- Radiation: High-Dose Rate Brachytherapy
- Other: Questionnaire Administration
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events Greater Than Grade 2 Serious Toxicity Rate, Defined as Toxicity Greater Than Grade 2 Using Common Terminology Criteria for Adverse Events Version 4.0 Criteria
- timeFrame
- 2 years
- description
- Measured by the data collected for toxicity and cosmesis as dichotomous variables. This will be assessed by physical examination at each follow-up visit. To be scored as a serious toxicity counting toward the primary endpoint, the toxicity must have a "probable" or "definite" attribution to the study treatment.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: * Must sign informed consent * Surgical treatment of the breast must have been lumpectomy; the margins of the resected specimen must be histologically free of tumor (negative surgical margins per National Surgical Adjuvant Breast and Bowel Project \[NSABP\] criteria) * On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) and/or invasive breast carcinoma * For patients with invasive breast cancer, an axillary staging procedure must be performed (either sentinel node biopsy \[SNB\] alone or axillary dissection \[with a minimum of six axillary nodes removed\], and the axillary node\[s\] must be pathologically negative); patients over 70 with estrogen receptor positive (ER+) tumors no greater than 2 cm do not require axillary evaluation, but MUST be clinically node negative on examination and all available imaging (clinical N0) * The T stage must be Tis, T1, or T2; if T2, the tumor must be =\< 3.0 cm in maximum diameter * Estrogen receptor positive tumor and/or progesterone receptor positive tumor Exclusion Criteria: * Pregnant or breast-feeding * Active collagen-vascular disease * Paget's disease of the breast * Prior history of DCIS or invasive breast cancer * Prior breast or thoracic radiation therapy (RT) for any condition * Multicentric carcinoma (DCIS or invasive) * Synchronous bilateral invasive or non-invasive breast cancer * Surgical margins that cannot be microscopically assessed or that are positive * Positive axillary node(s) * T stage of T2 with the tumor \> 3 cm in maximum diameter or a T stage \>= 3 * Estrogen receptor negative and progesterone receptor negative tumor * Any of the dosimetric treatment criteria as defined have not been met; patients who become ineligible due to inability to meet dosimetric criteria should not receive treatment as defined in this protocol and will come off the study; any subsequent adjuvant radiation will be delivered at the discretion of the treating physician
References
Publications (1)
- DERIVEDKhan AJ, Chen PY, Yashar C, Poppe MM, Li L, Abou Yehia Z, Vicini FA, Moore D, Dale R, Arthur D, Shah C, Haffty BG, Kuske R. Three-Fraction Accelerated Partial Breast Irradiation (APBI) Delivered With Brachytherapy Applicators Is Feasible and Safe: First Results From the TRIUMPH-T Trial. Int J Radiat Oncol Biol Phys. 2019 May 1;104(1):67-74. doi: 10.1016/j.ijrobp.2018.12.050. Epub 2019 Jan 4. PMID 30611839