Clinical trial · Interventional
Radiation Therapy in Treating Women With Locally Recurrent Breast Cancer Previously Treated With Repeat Breast-Preserving Surgery
A Phase II Study of Repeat Breast Preserving Surgery and 3D-Conformal Partial Breast Re-Irradiation (PBrI) for Local Recurrence of Breast Carcinoma
- 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)
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery kill any remaining tumor cells and may be an effective treatment for breast cancer. PURPOSE: This phase II trial is studying how well radiation therapy works in treating women with locally recurrent breast cancer previously treated with repeat breast-conserving surgery.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D-Conformal External Beam | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Partial Breast Re-Irradiation
- description
- Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
- interventionNames
- Radiation: 3D-Conformal External Beam
Primary outcomes (1)
- measure
- Number of Participants With Grade 3+ Treatment-related Skin, Fibrosis, and Breast Pain Adverse Events
- timeFrame
- From the end of radiation to 1 year.
- description
- Adverse events (AEs) were graded with Common Terminology Criteria for Adverse Events (CTCAE) version 4. Grade refers to the severity of the AE. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE. Based on a rate of 4% for the AEs of interest, a rate of ≥ 13% for these AEs with re-irradiation would be unacceptable. A sample size of 55 evaluable pts (eligible \& started protocol treatment) would provide: 86% power to conclude an unacceptable rate of the specified AEs, if the true AE rate was at least 13%; 93% probability to not conclude an unacceptable rate of the specified AEs, if the true AE rate is 4%. If ≥ 5 pts have treatment-related AEs, then the treatment-related AE rate was considered unacceptable.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed locally recurrent breast carcinoma consistent with the following cell types:
* Invasive ductal breast carcinoma
* Medullary ductal breast carcinoma
* Tubular ductal breast carcinoma
* Mucinous ductal breast carcinoma
* Lobular breast carcinoma
* Ductal carcinoma in situ (DCIS)
* No Paget disease of the nipple
* Target lumpectomy cavity must be clearly defined and the target lumpectomy cavity/ whole-breast reference volume must be \< 30% based on a post-operative, pre-treatment CT scan
* Tumor size ≤ 3 cm in greatest dimension on pathologic specimen
* Negative histologic margins of resection and no tumor on ink following breast-preserving surgery of local recurrence (Re-excision is permitted to achieve negative margins)
* Axilla negative or ≤ 3 positive lymph nodes without extracapsular extension
* If the in-breast recurrence is DCIS and/or microinvasive disease, a sentinel lymph node (SLN) evaluation is not required, but if performed:
* Patients with a negative sentinal lymph node (SLN) biopsy are eligible for enrollment
* Patients with a positive SLN biopsy require an axillary lymph node (ALN) dissection (ALND is not required if the SLN is not identified)
* Patient is eligible if 0-3 positive ALNs without extracapsular extension is documented
* If the in-breast recurrence is invasive disease and:
* No prior ALN dissection or SLN dissection only:
* Patient is required to undergo axillary evaluation with either a SLN or ALN dissection
* If the SLN is not identified or if the SLN is positive for metastatic disease then an ALN dissection is required
* Patient is eligible for enrollment if encounter 0-3 positive lymph nodes without extracapsular extension
* • Prior ALN dissection: negative clinical exam: patient is eligible for enrollment
* It is recommended, but not required, that the patient undergo ultrasound evaluation of the axilla and the lymph node draining regions of the breast; any suspicious areas are to be biopsied and if positive followed with an ALN dissection
* Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension are encountered
* Prior ALN dissection: positive clinical exam: biopsy required
* If biopsy is negative, patient is eligible for enrollment
* If biopsy is positive an ALN dissection is required
* Patient is eligible for enrollment if biopsies are negative or 0-3 axillary lymph nodes without extracapsular extension encountered
* Ipsilateral breast mammogram and MRI within 120 days prior to study entry
* Contralateral breast mammogram within 12 months of study entry
* For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan
* No multicentric ipsilateral breast recurrence or regional recurrence (other than axilla)
* Patients must have a breast technically amenable to partial-breast irradiation
* No metastatic disease documented by physical exam or radiographic evaluation (for patients with invasive disease)
* No skin involvement
* No prior contralateral mastectomy
* Estrogen and progesterone status must be known
PATIENT CHARACTERISTICS:
* Zubrod performance status 0-1
* Menopausal status not specified
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other invasive malignancy within the past 3 years except ipsilateral breast cancer and/or nonmelanoma skin cancer
* No collagenous diseases, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
* No psychiatric or addictive disorders that would preclude obtaining informed consent
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* More than 2 weeks since prior chemotherapy and recovered
* No concurrent intensity-modulated radiotherapy
* No concurrent chemotherapeutic agents, including trastuzumabReferences
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