Know Cancer

forgot password

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

Phase 3
50 Years
Open (Enrolling)
Breast Cancer, Lumpectomy

Thank you

Trial Information

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

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

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

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.

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)

- 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

- 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

- No geographical, social or psychologic reasons that would prevent study follow

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

rate of local recurrence

Outcome Description:

To estimate and compare the rate of local recurrence between the experimental and control arms.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Yazid Belkacemi, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Henri Mondor Hospital AP-HP, Créteil, France


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2010

Completion Date:

October 2023

Related Keywords:

  • Breast Cancer
  • Lumpectomy
  • breast cancer
  • Accelerated Partial Breast Irradiation
  • invasive cancer
  • Hypofractionated Irradiation
  • Lumpectomy
  • Breast Neoplasms