Back to results

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

Primary Purpose

Breast Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Netherlands

Study Type

Interventional

Intervention

Single dose ablative radiotherapy

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring 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

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Amsterdam UMCRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pre-operative single dose partial breast irradiation

Arm Description

Outcomes

Primary Outcome Measures

Pathologic complete response

pCR is defined as the absence of residual invasive cancer on resected breast specimen

Secondary Outcome Measures

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.

Treatment-related adverse events

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0

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)

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)

Patient distress

PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire

Physician reported cosmetic outcome

Cosmetic outcome is assessed by the physician using a questionnaire

Patient reported cosmetic outcome

Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. .

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.

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.

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.

Radiotherapy-associated immune response markers

Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery.

Radiotherapy-associated biomarkers

ctDNA will be assessed in blood samples taken between radiotherapy and surgery.

Full Information

NCT ID

NCT05350722

First Posted

March 14, 2022

Last Updated

September 14, 2022

Sponsor

Amsterdam UMC, location VUmc

Collaborators

Dutch Cancer Society

1. Study Identification

Unique Protocol Identification Number

NCT05350722

Brief Title

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

Acronym

ABLATIVE-2

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 24, 2022 (Actual)

Primary Completion Date

March 2025 (Anticipated)

Study Completion Date

March 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Amsterdam UMC, location VUmc

Collaborators

Dutch Cancer Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Pre-operative single dose partial breast irradiation

Arm Type

Experimental

Intervention Type

Radiation

Intervention Name(s)

Single dose ablative radiotherapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Pathologic complete response

Description

pCR is defined as the absence of residual invasive cancer on resected breast specimen

Time Frame

12 months after radiotherapy

Secondary Outcome Measure Information:

Title

Radiologic complete response

Description

Time Frame

at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy

Title

Treatment-related adverse events

Description

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0

Time Frame