Overview

This trial is active, not recruiting.

Conditions breast cancer, lumpectomy
Treatments whole breast irradiation + boost or hypofractionated irradiation, accelerated partial breast irradiation
Phase phase 3
Sponsor UNICANCER
Start date December 2010
End date October 2020
Trial size 1006 participants
Trial identifier NCT01247233, 2010-A00243-36, RTS02 / SHARE, RTS02-SHARE, UC-0140/1001

Summary

The standard treatment for localized breast cancer is based on conservative surgery (when possible) followed by radiation therapy (RT) delivered to the whole breast. The recommended total RT dose is 45 to 50 Gy delivered in 4.5 to 5 weeks followed by a 10 to 16 Gy boost to the tumor bed for 1 to 1.5 weeks. The rationale for the development of APBI was based on the difficulty for many patients to reach RT centers to receive standard whole breast irradiation (WBI) after conservative surgery. APBI offers decreased overall treatment time and several theoretical advantages over WBI, including a decrease in dose delivered to uninvolved portions of the breast and adjacent organs. If equivalence between the two treatments can be shown, then APBI will be considered as a historic evolution in breast cancer management.

In this phase III trial, designed in postmenopausal women > 50 years of age, the objective is to compare the effectiveness and safety of APBI compared with whole breast irradiation. This study is also designed to ensure high quality criteria for surgery, pathology and RT techniques in the 3 arms and will allow to provide data on economics and costs.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Whole breast RT, 50Gy + "boost" 16Gy. Whole breast hypofractionated RT without boost, either 40Gy or 42,5Gy.
whole breast irradiation + boost or hypofractionated irradiation Standard radiation
Whole Breast Irradiation 50Gy + Boost 16 Gy or Whole breast, either 40Gy in 15 fractions in 3 weeks or 42,5Gy in 16 fractions in 3 weeks
(Experimental)
APBI using 3D CRT technique, in 5 days, 38.5 Gy to the tumor bed .
accelerated partial breast irradiation APBI
Tumor bed 40Gy in 10 fractions, 2 fractions of 4Gy per day in 5 to 7 days.

Primary Outcomes

Measure
rate of local recurrence
time frame: 5 years

Secondary Outcomes

Measure
Ipsilateral breast recurrence-free survival
time frame: 10 years
Nodal regional recurrence-free survival
time frame: 10 years
Distant recurrence-free survival
time frame: 10 years
Disease-specific survival
time frame: 10 years
Overall survival
time frame: 10 years
Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects)
time frame: 10 years
Cosmetic: comparison of the cosmetic result (according to both the physician and the patient)
time frame: 10 years
Quality of Life and Satisfaction
time frame: 10 years
Medico-economic study
time frame: 3 years

Eligibility Criteria

Female participants at least 50 years old.

Inclusion Criteria: - Women aged ≥ 50 years - Menopausal status confirmed - Pathology confirmation of invasive carcinoma (all types) - Complete tumor removal and conservative surgery - Pathologic tumor size of invasive carcinoma ≤ 2cm (including the in situ component) pT1 - All histopathologic grades - Clear lateral margins for the invasive and in situ disease (> 2mm) - pN0 or pN(i+) - No metastasis - Radiotherapy should be started more than 4 weeks and less than 12 weeks after last surgery - Surgical clips (4 to 5 clips in the tumor bed) - No prior breast or mediastinal radiotherapy - ECOG 0-1 - Information to the patient and signed informed consent Exclusion Criteria: - Multifocal invasive ductal carcinoma defined as the presence of at least two distinct tumors that are separated by normal tissue or when the distance between the two lesions does not permit conservative surgery - Bilateral breast cancer - No or less than 4 surgical clips in the tumor bed - Nodal involvement : pN1 (including micrometastasis, mi+), pN2, pN3 - Metastatic disease - internal mammary node involvement or supraclavicular lymph node involvement - Indication of chemotherapy or trastuzumab - Involved or close lateral margins for the invasive and /or in situ components (< 2mm) AND impossibility to re-operate or impossible to perform another conservative surgery - Patients with known BRCA1 or BRCA2 mutations - Previous mammoplasty - Previous homolateral breast and/or mediastinal irradiation - Previous invasive cancer (except basocellular epithelioma or in situ carcinoma of the cervix) - No geographical, social or psychologic reasons that would prevent study follow

Additional Information

Official title Phase III Multicentric Trial Comparing Accelerated Partial Breast Irradiation (APBI) Versus Standard or Hypofractionated Whole Breast Irradiation in Low Risk of Local Recurrence of Breast Cancer
Principal investigator Yazid Belkacemi, MD PhD
Description Following breast conservative surgery, patients will be stratified according to the following prognostic factors using a minimisation technique: age (<70 vs ≥70), HER2 status (HER2+ vs HER2-), hormonal receptor status (RH+ vs RH-) and lymph node invasion (pN0 vs pN0i+). Patients will be allocated to receive either standard treatment, hypofractionated treatment or APBI. Radiation therapy should be started between 4 and 12 weeks after the last surgery. Patients treated with standard whole breast irradiation will receive a total dose of 50 Gy in 25 fractions, 2 Gy per day, 5 days a week. The boost of 16 Gy will be delivered in 8 fractions for all patients after completion of the 50 Gy, without interruption. All patients will receive one fraction per day, 5 fractions a week. Patients treated with hypofractionated irradiation will receive a total dose of either 40 Gy (in 15 fractions, 2.66 Gy per day) or 42.5 Gy (in 16 fractions, 2.65 Gy per day)5 days a week. Patients treated with APBI will receive a total dose of 40 Gy in 10 fractions, delivered twice a day over a time period of 5-7 days. Each daily dose must be separated by 6 hours. Patients will be followed at 3 and 6 month after the last dose of irradiation, at 12 months after the date of last surgery and then on a yearly basis during 10 years.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by UNICANCER.