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The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.
A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.
This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dose ablative radiotherapy | Experimental | Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose ablative radiotherapy | Radiation | A single dose ablative radiotherapy will be delivered prior to surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete response | 6 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Radiological tumor response on MRI according to the RECIST criteria | Within 1 week and 2, 4 and 6 months after radiotherapy | |
| Radiological tumor response on FDG-PET-CT according to the PERCIST criteria | At 6 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor related genetic characteristics associated with radiotherapy responsiveness | Future research proposal performed within 10 years after radiotherapy | Until 10 years after radiotherapy |
Inclusion Criteria:
WHO performance scale ≤2.
Females at least 50 years of age with unifocal cT1N0 breast cancer or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:
- Tumor size as assessed on MRI
On tumor biopsy:
Tumor negative sentinel node.
Adequate communication and understanding skills of the Dutch language.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HJGD van den Bongard, MD, PhD | UMC Utrecht | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Utrecht | Utrecht | 3584 CX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33761491 | Derived | Groot Koerkamp ML, de Hond YJM, Maspero M, Kontaxis C, Mandija S, Vasmel JE, Charaghvandi RK, Philippens MEP, van Asselen B, van den Bongard HJGD, Hackett SS, Houweling AC. Synthetic CT for single-fraction neoadjuvant partial breast irradiation on an MRI-linac. Phys Med Biol. 2021 Apr 16;66(8). doi: 10.1088/1361-6560/abf1ba. | |
| 28274211 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires | Until 10 years after radiotherapy |
| Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software | Until 10 years after radiotherapy |
| Frailty assessment according to the Groningen Frailty Indicator | Until 10 years after radiotherapy |
| Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire. | Until 10 years after radiotherapy |
| Local relapse rates | Until 10 years after radiotherapy |
| Regional relapse rates | Until 10 years after radiotherapy |
| Distant relapse rates | Until 10 years after radiotherapy |
| Disease free survival | Until 10 years after radiotherapy |
| Overall survival | Until 10 years after radiotherapy |
| Charaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ. Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol. BMC Cancer. 2017 Mar 9;17(1):181. doi: 10.1186/s12885-017-3144-5. |
| D017437 |
| Skin and Connective Tissue Diseases |