NCT03863301

Brief Summary

This study aims to evaluate the pathologic response at 12 months after single dose preoperative partial breast irradiation in early stage breast cancer patients. Furthermore, the aim is to collect data on response monitoring. Patient-reported outcome measures and treatment-induced toxicity will be evaluated.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
66mo left

Started Mar 2019

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress57%
Mar 2019Nov 2031

First Submitted

Initial submission to the registry

January 15, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 5, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2031

Expected
Last Updated

February 26, 2021

Status Verified

February 1, 2021

Enrollment Period

3.7 years

First QC Date

January 15, 2019

Last Update Submit

February 23, 2021

Conditions

Breast Cancer

Keywords

Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • Pathologic complete response (pCR)

    pCR is assessed 6 or 12 months following single dose radiotherapy. Patients will undergo breast-conserving surgery.

    up to 12 months

Secondary Outcomes (15)

  • Radiologic response on MRI

    up to 12 months

  • Biopsy of irradiated tumor

    up to 12 months

  • Treatment-induced toxicity

    10 years

  • Patient reported outcomes - quality of life

    10 years

  • Patient reported outcomes - quality of life

    10 years

  • +10 more secondary outcomes

Other Outcomes (1)

  • Dosimetry of radiotherapy in prone position

    1 month

Study Arms (1)

MR-guided single dose preoperative PBI

EXPERIMENTAL
Radiation: MR-guided single dose preoperative PBI

Interventions

MR-guided single dose preoperative PBIRADIATION

A single dose of 20Gy to the gross tumor volume (GTV) is prescribed, to the clinical target volume (GTV + 20mm margin) 15Gy is prescribed.

MR-guided single dose preoperative PBI

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 unifocal cT1-2(maximum 3 cm)N0 breast cancer on mammography, ultrasound and MRI.
  • Patients with an indication for chemotherapy or immunotherapy 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.
  • Adequate communication and understanding skills of the Dutch language.

You may not qualify if:

  • Legal incapacity.
  • BRCA1, BRCA2 or CHEK2 gene mutation.
  • Previous history of breast cancer or DCIS.
  • Collagen synthesis disease.
  • Signs of extensive DCIS component on histological biopsy or imaging.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Desiree van den Bongard, MD PhD

    UMC Utrecht

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single arm interventional cohort study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 15, 2019

First Posted

March 5, 2019

Study Start

March 4, 2019

Primary Completion

November 1, 2022

Study Completion (Estimated)

November 1, 2031

Last Updated

February 26, 2021

Record last verified: 2021-02

Locations

NL(1)