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| Name | Class |
|---|---|
| Dutch Cancer Society | OTHER |
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In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.
Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-operative single dose partial breast irradiation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose ablative radiotherapy | Radiation | Patients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation |
| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response | pCR is defined as the absence of residual invasive cancer on resected breast specimen | 12 months after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Radiologic complete response | Radiologic complete response (rCR) is defined as complete absence of pathologic contrast enhancement in the original tumor bed and complete absence of pathologic ADC (apparent diffusion coefficient) reduction in the original tumor bed. rCR is reported according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines. | at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy |
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Inclusion Criteria:
WHO performance scale ≤2.
Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.
On tumor biopsy:
Tumor-negative sentinel node (excluding isolated tumor cells).
Adequate communication and understanding skills of the Dutch language.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yasmin Civil, MD | Contact | 020 4441484 | y.civil@amsterdamumc.nl | |
| Desirée van den Bongard, MD, PhD | Contact | h.j.vandenbongard@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Desirée van den Bongard, MD, PhD | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GenesisCare | Not yet recruiting | Sydney | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37161377 | Derived | Civil YA, Oei AL, Duvivier KM, Bijker N, Meijnen P, Donkers L, Verheijen S, van Kesteren Z, Palacios MA, Schijf LJ, Barbe E, Konings IRHM, -van der Houven van Oordt CWM, Westhoff PG, Meijer HJM, Diepenhorst GMP, Thijssen V, Mouliere F, Slotman BJ, van der Velde S, van den Bongard HJGD. Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial-a study protocol. BMC Cancer. 2023 May 9;23(1):419. doi: 10.1186/s12885-023-10910-6. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Treatment-related adverse events | Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0 | at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy |
| Patient quality of life | PROMs are assessed using the European Organization for Research and Treatment of Cancer core-30 quality of life questionnaire (EORTC QLQ-C30) | at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy |
| Breast cancer specific quality of life | PROMs are assessed using the European Organization for Research and Treatment of Cancer breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23) | at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy |
| Patient distress | PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire | at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy |
| Physician reported cosmetic outcome | Cosmetic outcome is assessed by the physician using a questionnaire | at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy |
| Patient reported cosmetic outcome | Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. . | at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy |
| Objective cosmetic outcome | Cosmetic outcome is assessed objectively using images captured using the VECTRA XT 3D-imaging system. This three-dimensional surface-imaging system uses stereophotogrammetry to estimate x, y, z coordinates of the imaged surface. These coordinates will be used to calculate the volume-shape-symmetry measure. | at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy |
| Local, regional and distant relapse rates | A local recurrence is defined as disease occurrence in the ipsilateral breast. A regional recurrence is defined as nodal occurrence in the ipsilateral axilla, internal mammary, infraclavicular or supraclavicular region. A distant metastasis defined as disease occurrence in the contralateral breast or contralateral breast nodal region or another organ than breast involvement. | Day of radiotherapy till end of follow-up of 10 years |
| Overall survival | Overall survival will be calculated from the date of the radiotherapy treatment until the time of breast-cancer related death or breast-cancer unrelated death. | Day of radiotherapy till end of follow-up of 10 years |
| Radiotherapy-associated immune response markers | Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery. | 12 months after radiotherapy |
| Radiotherapy-associated biomarkers | ctDNA will be assessed in blood samples taken between radiotherapy and surgery. | at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy |
| Flevoziekenhuis | Recruiting | Almere Stad | Netherlands |
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| Ziekenhuis Amstelland | Recruiting | Amstelveen | Netherlands |
|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
|
| Canisius Wilhelmina Ziekenhuis | Recruiting | Nijmegen | Netherlands |
|
| Radboud UMC | Recruiting | Nijmegen | Netherlands |
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| Zaans Medisch Centrum | Recruiting | Zaandam | Netherlands |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |