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Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients (ABLATIVE-2)

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ClinicalTrials.gov Identifier: NCT05350722
Recruitment Status : Recruiting
First Posted : April 28, 2022
Last Update Posted : September 15, 2022
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
H.J.G.D. van den Bongard, Amsterdam UMC, location VUmc

Tracking Information
First Submitted Date  ICMJE March 14, 2022
First Posted Date  ICMJE April 28, 2022
Last Update Posted Date September 15, 2022
Actual Study Start Date  ICMJE August 24, 2022
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 21, 2022)
Pathologic complete response [ Time Frame: 12 months after radiotherapy ]
pCR is defined as the absence of residual invasive cancer on resected breast specimen
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 21, 2022)
  • Radiologic complete response [ Time Frame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy ]
    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.
  • Treatment-related adverse events [ Time Frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy ]
    Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0
  • Patient quality of life [ Time Frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy ]
    PROMs are assessed using the European Organization for Research and Treatment of Cancer core-30 quality of life questionnaire (EORTC QLQ-C30)
  • Breast cancer specific quality of life [ Time Frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy ]
    PROMs are assessed using the European Organization for Research and Treatment of Cancer breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23)
  • Patient distress [ Time Frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy ]
    PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire
  • Physician reported cosmetic outcome [ Time Frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy ]
    Cosmetic outcome is assessed by the physician using a questionnaire
  • Patient reported cosmetic outcome [ Time Frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy ]
    Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. .
  • Objective cosmetic outcome [ Time Frame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy ]
    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.
  • Local, regional and distant relapse rates [ Time Frame: Day of radiotherapy till end of follow-up of 10 years ]
    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.
  • Overall survival [ Time Frame: Day of radiotherapy till end of follow-up of 10 years ]
    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.
  • Radiotherapy-associated immune response markers [ Time Frame: 12 months after radiotherapy ]
    Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery.
  • Radiotherapy-associated biomarkers [ Time Frame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy ]
    ctDNA will be assessed in blood samples taken between radiotherapy and surgery.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Official Title  ICMJE Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Radiation: Single dose ablative radiotherapy
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
Study Arms  ICMJE Experimental: Pre-operative single dose partial breast irradiation
Intervention: Radiation: Single dose ablative radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 21, 2022)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2035
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • WHO performance scale ≤2.
  • Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.

    • Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
    • Tumor size as assessed on MRI.
  • On tumor biopsy:

    • Bloom-Richardson grade 1 or 2.
    • Non-lobular invasive histological type carcinoma.
    • LCIS or (non-extensive) DCIS is accepted.
    • ER positive tumor receptor.
    • HER2 negative tumor.
  • Tumor-negative sentinel node (excluding isolated tumor cells).
  • Adequate communication and understanding skills of the Dutch language.

Exclusion Criteria:

  • Legal incapacity.
  • BRCA1, BRCA2 or CHEK2 gene mutation.
  • Distant metastasis.
  • Previous history of breast cancer or DCIS.
  • Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
  • For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
  • Collagen synthesis disease.
  • Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).
  • Invasive lobular carcinoma.
  • MRI absolute contraindications as defined by the Department of Radiology.
  • Nodal involvement with cytological or histological confirmation.
  • Indication for treatment with (neo-)adjuvant chemotherapy.
  • Non-feasible dosimetric RT plan.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yasmin Civil, MD 020 4441484 y.civil@amsterdamumc.nl
Contact: Desirée van den Bongard, MD, PhD h.j.vandenbongard@amsterdamumc.nl
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05350722
Other Study ID Numbers  ICMJE NL77000.029.21
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party H.J.G.D. van den Bongard, Amsterdam UMC, location VUmc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Amsterdam UMC, location VUmc
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Dutch Cancer Society
Investigators  ICMJE
Principal Investigator: Desirée van den Bongard, MD, PhD Amsterdam UMC, location VUmc
PRS Account Amsterdam UMC, location VUmc
Verification Date September 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP