Standard or Hypofractionated Radiotherapy Versus Accelerated Partial Breast Irradiation (APBI) for Breast Cancer

Conditions

Breast Cancer, Lumpectomy

Keywords

breast cancer, Accelerated Partial Breast Irradiation, invasive cancer, Hypofractionated Irradiation, Lumpectomy

Brief 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.

Detailed 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.

Yazid Belkacémi, Isabelle Flandin, Marie‐Cécile Le Deley, Clemence Leguillette, Kamel Debbi et al. (20 authors)

Journal of Clinical Oncology2025-05-28

10.1200/jco.2025.43.16_suppl.514

Abstract PD3-05: Early results of the French multicenter, randomized SHARE trial comparing whole breast irradiation versus accelerated partial breast irradiation in postmenopausal women with early-stage breast cancer

Yazid Belkacémi, Isabelle Gabelle-Flandin, Marie‐Cécile Le Deley, Adeline Petit, Philippe Guilbert et al. (28 authors)

Cancer Research2023-03-01

10.1158/1538-7445.sabcs22-pd3-05

CANTO-RT: One of the Largest Prospective Multicenter Cohort of Early Breast Cancer Patients Treated with Radiotherapy including Full DICOM RT Data

Thomas Sarrade, Rodrigue S. Allodji, Youssef Ghannam, Guillaume Auzac, Sibille Everhard et al. (15 authors)

Cancers2023-01-2512 citations

10.3390/cancers15030751

Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT LOW trial): 5-year results from a multicentre, randomised, controlled, phase 3, non-inferiority trial.

Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM, IMPORT Trialists.

2017-08-02406 citations

10.1016/s0140-6736(17)31145-5

Interventions

RADIATIONWhole Breast Irradiation + Boost or Hypofractionated irradiation

Whole Breast Irradiation 50 Gy + Boost 16 Gy or Whole breast, either 40 Gy in 15 fractions in 3 weeks or 42.5 Gy in 16 fractions in 3 weeks

RADIATIONAccelerated partial breast irradiation

Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

Healthy volunteers

No

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 ≤2 cm (including the in situ component) pT1 * All histopathologic grades * Clear lateral margins for the invasive and in situ disease (\>2 mm) * 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 * Eastern Cooperative Oncology Group (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 (\<2 mm) 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

Design outcomes

Primary

Measure	Time frame	Description
rate of local recurrence	5 years	To estimate and compare the rate of local recurrence between the experimental and control arms.

Secondary

Measure	Time frame	Description
Distant recurrence-free survival	10 years	To evaluate distant recurrence-free survival
Disease-specific survival	10 years	To evaluate disease-specific survival
Overall survival	10 years	To evaluate the overall survival
Ipsilateral breast recurrence-free survival	10 years	To evaluate Ipsilateral breast recurrence-free survival
Nodal regional recurrence-free survival	10 years	To evaluate nodal regional recurrence-free survival
Cosmetic: comparison of the cosmetic result (according to both the physician and the patient)	10 years	To evaluate Cosmetic results (Patient and Physician evaluations)
Quality of Life and Satisfaction	10 years	To evaluate the patient quality of life and patient satisfaction
Medico-economic study	3 years	To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation
Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects)	10 years	To evaluate rates and type of acute and late toxicities

Countries

France

Outcome results

None listed