Study on Recurrent Breast Cancer and Repeated Radiation Therapy (RAY-no-BAN)

This study explores whether recurrent breast cancer can be safely treated with breast-conserving surgery and repeated radiation therapy in cases where patients have previously undergone radiation. Traditionally, recurrent breast cancer has been treated by removing the entire breast. However, recent research has shown that in certain situations, it may be possible to preserve the breast.

The study will collect data on the safety of this treatment approach and its effects on patients. The treatment follows standard breast cancer care practices, involving 30 patients from Helsinki and Turku University Hospitals. Patients are carefully selected based on specific criteria, such as tumor size, localization, and prior treatment history. Special attention is given to the planning of radiation therapy and surgical techniques.

The goal is to develop new treatment strategies that allow breast preservation even in cases of recurrent breast cancer, providing patients with high-quality and individualized care.

Study Overview

• Status: Recruiting
• Conditions: Recurrent Breast Carcinoma
• Intervention / Treatment: Radiation: Breast conserving surgey and radiotherapy; Procedure: Mastectomy

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anselm Tamminen, MD, PhD; Phone Number: +3583130000; Email: jlatam@utu.fi

Study Locations

• Finland
  • Helsinki, Finland
    • Recruiting
    • Helsinki University Hospital
    • Contact: Tuomo Meretoja, MD, PhD; Phone Number: +358504272 877; Email: tuomo.meretoja@hus.fi
  • Turku, Finland
    • Recruiting
    • Turku University Hospital
    • Contact: Anselm Tamminen, MD, PhD; Email: jlatam@utu.fi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient has a diagnosed breast cancer or tumor area in the breast with a maximum diameter of 3 cm, where a previous breast-conserving surgery has been performed (either invasive breast cancer or carcinoma in situ, DCIS).

The patient has only a local recurrence, and imaging studies show no suspicion of metastases outside the breast (preoperative staging N0M0).

At least 3 years have passed since the completion of prior radiation therapy. The new breast cancer can be technically treated with another breast-conserving surgery using a technique that does not require tissue transfer from areas opposite the removed tumor to restore the shape of the breast.

The patient is at least 55 years old at the time of surgery. The patient is willing to participate in the study. The patient is capable of providing informed consent.

Exclusion Criteria:

• A booster dose, also known as a "boost," was administered during prior radiation therapy.

Preoperative assessments suggest multifocal breast cancer, with the tumor area to be removed exceeding 3 cm.

The planned radiation therapy per the study protocol cannot be administered due to factors such as shoulder joint stiffness, a pacemaker located in the radiation field, or a skin condition (e.g., scleroderma).

The patient is unable to provide informed consent or is unwilling to participate in the study.

Metastases outside the breast (e.g., axillary or distant metastases) are present.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Repeat breast conserving surgery and radiotherapy Arm; The patients in this arm undergo repeat breast conserving surgery and partial breast radiotherapy	Radiation: Breast conserving surgey and radiotherapy; The patients will undergo repeat Breast Conserving Surgery and Radiotherapy
Active Comparator: Mastectomy Arm; The patients in this arm undergo mastectomy	Procedure: Mastectomy; The patients will undergo mastectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A treatment-limiting radiation therapy complication.	Any complication related to radiation therapy, that would limit completing the radiotherapy	From the beginning of the radiotherapy until 30 days after finishing the therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Second Breast Cancer Recurrence	The patients are surveilled for second breast cancer recurrence	5 years from surgery
Secondary malignancies	The patients are surveilled for any other secondary malignancy than breast cancer	5 years
Quality of life (Breast-Q scale)	Patients are asked to complete a quality of life questionnaire (Breast-Q) before the surgery and at 3 months, 1 year, 3 years, and 5 years after the surgery.	5 years from surgery
Quality of life (EORTC QLQ-C30)	Patients are asked to complete a quality of life questionnaire (EORTC QLQ-C30) before the surgery and at 3 months, 1 year, 3 years, and 5 years after the surgery	5 years from the operation

Collaborators and Investigators

• Sponsor: Turku University Hospital
• Collaborators: Helsinki University Central Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Breast cancer; Recurrence; Radiation therapy; Repeat radiation therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Disease Attributes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Recurrence; Breast Neoplasms; Therapeutics; Surgical Procedures, Operative; Radiotherapy; Mastectomy
• Other Study ID Numbers: T1641/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No