Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer

Breast Cancer Clinical Trial

— PAPBI-3  

Official title:

Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06362616
• Other study ID #: N23PBD
• Status: Recruiting
• Phase: N/A
• Start date: April 12, 2024
• Est. completion date: April 11, 2027

Study information

• Verified date: April 2024
• Source: The Netherlands Cancer Institute
• Contact: Tess Snellen, MD
• Phone: 0205129111
• Email: t.snellen[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer.

Description:

Standard treatment for an ipsilateral breast recurrence is a salvage mastectomy. However, repeat breast conserving therapy, involving breast conserving surgery (BCS) and postoperative re-irradiation, is a feasible alternative for a selected group of patients. In the primary setting, accelerated partial breast irradiation (APBI) is an international accepted treatment for a subset of breast cancer patients. Preoperative APBI (PAPBI) leads to low complication rates, limited fibrosis/induration in a small volume and good to excellent cosmetic results compared with results reported after postoperative APBI. The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer. Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 31
• Est. completion date: April 11, 2027
• Est. primary completion date: October 11, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 51 Years and older

Eligibility

Inclusion Criteria:

• Female patients = 51 years
• Ipsilateral breast cancer; recurrence or second primary
• Histologically proven invasive adenocarcinoma (invasive adenocarcinoma with ductal carcinoma in situ (DCIS) component is also accepted)
• Histologically proven estrogen receptor positive, HER2neu-negative
• Tumor size = 3 cm
• Grade I or grade II (biopsy)
• cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan)
• Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision)
• Interval since completion of local treatment of primary tumor > 12 months
• Previous radiotherapy (whole breast or partial) of the ipsilateral breast
• Repeat breast conserving surgery feasible
• World Health Organization (WHO) performance = 2
• Written informed consent
• The patient is legally competent

Exclusion Criteria:

• = grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
• Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
• Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
• Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
• DCIS only, i.e. no invasive carcinoma present
• Triple negative or HER2-positive subtype
• Lymphovascular invasion in biopsy
• Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy = 2 months)
• (Planned) oncoplastic surgery with major tissue displacement
• Participation in another clinical trial that interferes with the locoregional treatment of this protocol.
• It is expected that dosimetric constraints cannot be met, such as lung/heart constraints.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• Preoperative accelerated partial breast irradiation
Patients will be treated with 5 x 5.2 Gray (Gy) preoperative accelerated partial breast irradiation of the in situ tumor in the breast

Procedure:
• Breast conserving surgery
Patients will be treated with breast conserving surgery.
• Sentinel node procedure
Patients will undergo a (repeat) sentinel node procedure.
• Biopsy track removal
The biopsy track will be surgically removed.

Locations

Country	Name	City	State
Netherlands	The Netherlands Cancer Institute	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute post-treatment toxicity	Acute post-treatment toxicity from start of local treatment up to 3 months after end of local treatment, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. At least grade = 2 toxicity is scored as an event.	3,5 months
Secondary	Fibrosis/induration	Assessment of fibrosis/induration grade at 3 months after end of local treatment, assessed the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value.	3 months
Secondary	Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30	PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.	3,5 months
Secondary	Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23	PROMs will be assessed using the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-BR23 questionnaire. All of the scales and single-item measures range in score from 0 to 100. A high score for the functional scales represents a high/healthy level of functioning, whilst a high score for the symptom scales represents a high level of symptomatology or problems.	3,5 months
Secondary	Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis	PROMs will be assessed using the Patient's Questionnaire Cosmesis, adapted from Sneeuw et al. (1992). Patients score their cosmetic outcome by the following outcomes: very satisfied, satisfied, neutral, unsatisfied and very unsatisfied.	3,5 months
Secondary	Cosmetic outcome according to the BCCT.core software program	Cosmetic outcome according to the Breast Cancer Conservative Treatment cosmetic results (BCCT.core) software program. The program returns an overall cosmetic outcome score (excellent, good, fair, or poor) based on the symmetry of the breasts, skin color, and scar visibility.	3,5 months