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NCT Number: NCT06704659

Study on Recurrent Breast Cancer and Repeated Radiation Therapy

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.

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki University Hospital, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Breast conserving surgey and radiotherapy

Radiation

The patients will undergo repeat Breast Conserving Surgery and Radiotherapy

mastectomy

Procedure

The patients will undergo mastectomy

Primary outcomes

  1. A treatment-limiting radiation therapy complication.

    Time frame: From the beginning of the radiotherapy until 30 days after finishing the therapy

    Any complication related to radiation therapy, that would limit completing the radiotherapy

Secondary outcomes

  1. Quality of life (Breast-Q scale)

    Time frame: 5 years from surgery

    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.

  2. Second Breast Cancer Recurrence

    Time frame: 5 years from surgery

    The patients are surveilled for second breast cancer recurrence

  3. Secondary malignancies

    Time frame: 5 years

    The patients are surveilled for any other secondary malignancy than breast cancer

  4. Quality of life (EORTC QLQ-C30)

    Time frame: 5 years from the operation

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Anselm Tamminen, MD, PhD

CONTACT

[email protected]

+3583130000

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Helsinki University Central Hospital

Registry information

Acronym: RAY-no-BAN

Important dates

Study start
2024
Primary completion
2026
Study completion
2030
First posted
Nov 26, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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