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Recruiting NCT05772390

Partial Breast Re-irradiation in Women in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation

Phase II Interventional Breast Cancer Recurrent

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Partial breast re-irradiation.
Who it may be relevant to
Registry conditions: Breast Cancer, Recurrent. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Partial Breast Re-irradiation in Women with Locally Recurrent Breast Cancer Previously Treated with Conservative Surgery and Whole Breast Irradiation: a Prospective Phase II Clinical Study

Overview

A prospective study of partial breast re-irradiation in patients with local recurrence of breast cancer

Detailed description

Breast cancer is the leading type of cancer in women worldwide. Although advances in treatment have led to an overall reduction in breast cancer mortality, survivors continue to have an ongoing risk of disease recurrence. For women who experience breast recurrence, mastectomy has historically been the only treatment approach offered. However, it has been associated with negative health outcomes, including reduced quality of life, depression and anxiety, and impaired sexual functioning. As a result, there is increasing interest to identify treatment options that include breast preservation. Breast-conserving surgery followed by re-irradiation with partial breast irradiation has recently been found to be a safe alternative to mastectomy for women who have undergone prior whole breast radiation.

Interventions

  • Radiation Partial breast re-irradiation
    partial breast re-irradiation

Primary outcome measures

  • Treatment related toxicity [Time frame: 12 months]
Secondary outcome measures (5)
  • in-breast recurrence in the ipsilateral breast [Time frame: 5 years]
  • Number of patients free from mastectomy over total number of patients [Time frame: 5 years]
  • To evaluate distant-metastasis free survival [Time frame: 5 years]
  • Overall survival [Time frame: 5 years]
  • Patient satisfaction [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • Isolated ipsilateral unifocal breast lesions;
  • Histologically confirmed invasive breast carcinoma or carcinoma in situ;
  • Limited size (\< 2 cm) without evidence of skin involvement;
  • Negative histologic margins of resection;
  • Negative axillary lymph nodes;
  • No synchronous distant metastases;
  • Bilateral breast mammogram or MRI within 120 days prior to study entry;
  • For invasive in-breast recurrence, no more than 120 days since whole-body (positron emission tomography) PET-CT scan OR CT scan of the chest, abdomen, and pelvis, and bone scan (if clinically relevant);
  • ≥ 24 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence;
  • Female, aged \>18 years;
  • Life expectancy of greater than 12 months;
  • ECOG performance status \<2;
  • Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study and for 4 months thereafter;
  • Participant is willing and able to give informed consent for participation in the study;

Exclusion criteria

  • Regional recurrences (axillary, supraclavicular);
  • Positive histologic margins at resection;
  • Metastatic disease;
  • Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;
  • Known pathogenic mutation of BRCA1, BRCA2 or TP53 gene;
  • Patients who had chemotherapy within 2 weeks prior to study RT;
  • Participation in another clinical trial with any investigational agents within 30 days prior to study screening;
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
  • Significant comorbidity precluding RT for breast cancer (cardiovascular or pulmonary disease, sclerodermia, systemic lupus erythematosus);
  • Other known malignant neoplastic diseases in the patient's medical history with a disease-free interval of less than 5 years (except for previously treated basal cell carcinoma of the skin and in situ carcinoma of the uterine cervix, endometrium or colon);
  • Inaccessibility for follow-up;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Italy · 1 center
  • UO Radioterapia, IRST IRCCS — Meldola

Identifiers

NCT: NCT05772390 · IRST174.25

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗