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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorIstituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Regional recurrences (axillary, supraclavicular);

Positive histologic margins at resection;

Metastatic disease;

Previous breast RT performed with IORT, brachytherapy or previous partial breast treatment;

Trial design

Design model

Single group

Treatments tested in this trial

  • Partial breast re-irradiation

    Radiation

    partial breast re-irradiation

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: Partial breast re-irradiationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Treatment related toxicity

determine the toxicity of partial breast re-irradiation (PBrI) as rate of grade ≥ 3 treatment-related skin, fibrosis, and breast pain Adverse Events, accordin to Common Terminology Criteria for Adverse Events scale 5.0 (Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild AE, Grade 2 Moderate AE, Grade 3 Severe AE, Grade 4 Life-threatening or disabling AE, Grade 5 Death related to AE) up to 1 year from completion of radiation treatment

Time frame
12 months

Secondary outcomes

1

in-breast recurrence in the ipsilateral breast

In-breast recurrence is defined histologic evidence of recurrent carcinoma, invasive or noninvasive (excluding lobular carcinoma in situ), in the ipsilateral breast

Time frame
5 years
2

Number of patients free from mastectomy over total number of patients

Freedom from mastectomy is calculated from mastectomy failure rates. Failure is a mastectomy of the treated breast performed for any reason

Time frame
5 years
3

To evaluate distant-metastasis free survival

Distant metastasis-free survival is defined as time from registration to the appearance of a distant metastasis confirmed radiographically and/or pathologically or death from any cause

Time frame
5 years
4

Overall survival

Overall survival is defined as time from registration to date of death or last follow-up

Time frame
5 years

Other outcomes

Sponsors and contacts

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