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| Name | Class |
|---|---|
| Medical Center Haaglanden | OTHER |
| Erasmus Medical Center | OTHER |
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This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Standard treatment for an ipsilateral breast recurrence is a salvage mastectomy. However, repeat breast conserving therapy, involving breast conserving surgery (BCS) and postoperative re-irradiation, is a feasible alternative for a selected group of patients. In the primary setting, accelerated partial breast irradiation (APBI) is an international accepted treatment for a subset of breast cancer patients. Preoperative APBI (PAPBI) leads to low complication rates, limited fibrosis/induration in a small volume and good to excellent cosmetic results compared with results reported after postoperative APBI.
The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Preoperative accelerated partial breast re-irradiation | Experimental | Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative accelerated partial breast irradiation | Radiation | Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast |
| Measure | Description | Time Frame |
|---|---|---|
| Acute post-treatment toxicity | Acute post-treatment toxicity from start of local treatment up to 3 months after end of local treatment, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. At least grade ≥ 2 toxicity is scored as an event. | 3,5 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fibrosis/induration | Assessment of fibrosis/induration grade at 3 months after end of local treatment, assessed the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. | 3 months |
| Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30 |
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Inclusion Criteria:
Exclusion Criteria:
Patients who were born as female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tess Snellen, MD | Contact | 0205129111 | 3448 | t.snellen@nki.nl |
| Lisa van den Hengel | Contact | 0205129111 | 9140 | l.vd.hengel@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| Astrid Scholten, MD PhD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Netherlands Cancer Institute | Recruiting | Amsterdam | 1066CX | Netherlands |
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| Breast conserving surgery | Procedure | Patients will be treated with breast conserving surgery. |
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| Sentinel node procedure | Procedure | Patients will undergo a (repeat) sentinel node procedure. |
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| Biopsy track removal | Procedure | The biopsy track will be surgically removed. |
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PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems. |
| 3,5 months |
| Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23 | PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems. | 3,5 months |
| Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis | PROMs will be assessed using the Patient's Questionnaire Cosmesis, adapted from Sneeuw et al. (1992). Patients score their cosmetic outcome by the following outcomes: very satisfied, satisfied, neutral, unsatisfied and very unsatisfied. | 3,5 months |
| Cosmetic outcome according to the BCCT.core software program | Cosmetic outcome according to the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software program. The program returns an overall cosmetic outcome score (excellent, good, fair, or poor) based on the symmetry of the breasts, skin color, and scar visibility. | 3,5 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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