Phase 2
Completed N=200
Accelerated Partial Breast Radiation Therapy Using High-Dose Rate Brachytherapy in Treating Patients With Early Stage Breast Cancer After Surgery
Ductal Breast Carcinoma In Situ · Estrogen Receptor Positive · Breast Cancer · Progesterone Receptor Positive
Source: ClinicalTrials.gov NCT02526498 ↗
Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: 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 — 200 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
200 | — |
| SECONDARY Local Control Rate, Assessed by Physical Examination |
— | — |
| SECONDARY Number of Participants With Good/Excellent Cosmetic Results, Using the Harvard Cosmesis Scale |
177 | — |
| SECONDARY Local Control Rate, Assessed by Mammography |
— | — |
Eligibility Criteria
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 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
Data sourced from ClinicalTrials.gov (NCT02526498). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.