Clinical trial NCT05350722: Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Official title: Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Low-risk breast cancer
Early stage breast cancer
Pre-operative radiotherapy
Partial breast irradiation
Pre-operative single dose radiation
pathologic complete response
cosmetic outcome
survival
toxicity
quality of life
neo-adjuvant radiotherapy
oncological outcomes
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Dutch Cancer Society
First posted: 2022-04-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pathologic complete response
timeFrame: 12 months after radiotherapy
Secondary outcomes:
measure: Radiologic complete response
timeFrame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
measure: Treatment-related adverse events
timeFrame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
measure: Patient quality of life
timeFrame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
measure: Breast cancer specific quality of life
timeFrame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
measure: Patient distress
timeFrame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
measure: Physician reported cosmetic outcome
timeFrame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
measure: Patient reported cosmetic outcome
timeFrame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
measure: Objective cosmetic outcome
timeFrame: at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
measure: Local, regional and distant relapse rates
timeFrame: Day of radiotherapy till end of follow-up of 10 years
measure: Overall survival
timeFrame: Day of radiotherapy till end of follow-up of 10 years
measure: Radiotherapy-associated immune response markers
timeFrame: 12 months after radiotherapy
measure: Radiotherapy-associated biomarkers
timeFrame: at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: GenesisCare
city: Almere
country: Netherlands
facility: Flevoziekenhuis
city: Amstelveen
country: Netherlands
facility: Ziekenhuis Amstelland
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis
city: Nijmegen
country: Netherlands
facility: Radboud UMC
city: Zaandam
country: Netherlands
facility: Zaans Medisch Centrum
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Desirée van den Bongard, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: