Study on Recurrent Breast Cancer and Repeated Radiation Therapy

NCT06704659 | Recruiting

• 1 other identifier: T1641/2024
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Recurrent Breast Carcinoma

Keywords

Breast cancer; Recurrence; Repeat radiation therapy; Radiation therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of life (Breast-Q scale)

  5 years from surgery

• Second Breast Cancer Recurrence

  5 years from surgery

• Secondary malignancies

  5 years

• Quality of life (EORTC QLQ-C30)

  5 years from the operation

Study Arms (2)

Repeat breast conserving surgery and radiotherapy Arm

EXPERIMENTAL

The patients in this arm undergo repeat breast conserving surgery and partial breast radiotherapy

Radiation: Breast conserving surgey and radiotherapy

Mastectomy Arm

ACTIVE COMPARATOR

The patients in this arm undergo mastectomy

Procedure: Mastectomy

Interventions

Breast conserving surgey and radiotherapy RADIATION

The patients will undergo repeat Breast Conserving Surgery and Radiotherapy

Repeat breast conserving surgery and radiotherapy Arm

Mastectomy PROCEDURE

The patients will undergo mastectomy

Mastectomy Arm

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turku University Hospital: lead
• Helsinki University Central Hospital: collaborator

Study Sites (2)

Helsinki University Hospital

Helsinki, Finland

RECRUITING

Turku University Hospital

Turku, Finland

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Recurrence

Interventions

Radiotherapy; Mastectomy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Central Study Contacts

Anselm Tamminen, MD, PhD

CONTACT

+3583130000; jlatam@utu.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 9, 2026

Record last verified: 2025-11

Locations

FI (2)