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Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
GenesisCare
NOT_YET_RECRUITING
Sydney
Netherlands
Flevoziekenhuis
RECRUITING
Almere Stad
Ziekenhuis Amstelland
RECRUITING
Amstelveen
Amsterdam UMC
RECRUITING
Amsterdam
Canisius Wilhelmina Ziekenhuis
RECRUITING
Nijmegen
Radboud UMC
RECRUITING
Nijmegen
Zaans Medisch Centrum
RECRUITING
Zaandam
Contact Information
Primary
Yasmin Civil, MD
y.civil@amsterdamumc.nl
020 4441484
Backup
Desirée van den Bongard, MD, PhD
h.j.vandenbongard@amsterdamumc.nl
Time Frame
Start Date: 2022-08-24
Estimated Completion Date: 2037-12
Participants
Target number of participants: 100
Treatments
Experimental: Pre-operative single dose partial breast irradiation
Related Therapeutic Areas
Sponsors
Collaborators: Dutch Cancer Society
Leads: Amsterdam UMC, location VUmc

This content was sourced from clinicaltrials.gov