Health TrialsbyHealthPanel

Study on Recurrent Breast Cancer and Repeated Radiation Therapy

ConditionRecurrent Breast Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age55+
SponsorTurku University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Breast conserving surgey and radiotherapy

    Radiation

    The patients will undergo repeat Breast Conserving Surgery and Radiotherapy

  • Mastectomy

    Procedure/Surgery

    The patients will undergo mastectomy

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Repeat breast conserving surgery and radiotherapy ArmExperimental treatment 1 intervention
Group B: Mastectomy ArmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

A treatment-limiting radiation therapy complication.

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

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

Secondary outcomes

1

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.

Time frame
5 years from surgery
2

Second Breast Cancer Recurrence

The patients are surveilled for second breast cancer recurrence

Time frame
5 years from surgery
3

Secondary malignancies

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

Time frame
5 years
4

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

Time frame
5 years from the operation

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Turku University Hospital

Lead sponsor

Helsinki University Central Hospital

Collaborator

Source ClinicalTrials.gov
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