Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01247233
Other study ID # RTS02-SHARE
Secondary ID 2010-A00243-36UC
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date December 27, 2010
Est. completion date October 2025

Study information

Verified date April 2024
Source UNICANCER
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1006
Est. completion date October 2025
Est. primary completion date December 7, 2020
Accepts healthy volunteers No
Gender Female
Age group 50 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Whole 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
Accelerated partial breast irradiation
Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.

Locations

Country Name City State
France Centre de traitement des Hautes energie - Clinique de l'Europe Amiens
France Centre Hospitalier Universitaire Amiens
France Institut Bergonié Bordeaux
France Centre Hospitalier Brive
France Centre Francois Baclesse Caen
France CH Chambery Chambery
France Hopital Henri Mondor Creteil
France Centre Leonard de Vinci Dechy
France CHU Michallon Grenoble
France Hôpital Robert Boulin Libourne
France Centre Oscar Lambret Lille
France CHU Dupuytren Limoges
France Centre Léon Bérard Lyon
France Institut Paoli Calmettes Marseille
France Clinique du Pont de Chaume Montauban
France Centre Hospitalier Montélimar
France CRLC Val d'Aurelle Montpellier
France Centre Hospitalier de Mulhouse Mulhouse
France Centre d'Oncologie de Gentilly Nancy
France Clinique Hartmann Neuilly sur Seine
France Centre de Haute Energie Nice
France Groupe Hospitalier Pitié Salpétrière Paris
France Hopital Tenon Paris
France Saint Louis Hospital Paris
France Centre Catalan d'Oncologie Perpignan
France Institut Jean Godinot Reims
France Centre Eugène Marquis Rennes
France CH de Roanne Roanne
France Centre Henri Becquerel Rouen
France Institut de Cancérologie de la Loire Saint Priest en Jarez
France Centre Paul Stauss Strasbourg
France Centre Marie Curie Valence
France Centre Alexis Vautrin Vandoeuvre les Nancy
France Institut Gustave Roussy Villejuif

Sponsors (1)

Lead Sponsor Collaborator
UNICANCER

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary rate of local recurrence To estimate and compare the rate of local recurrence between the experimental and control arms. 5 years
Secondary Ipsilateral breast recurrence-free survival To evaluate Ipsilateral breast recurrence-free survival 10 years
Secondary Nodal regional recurrence-free survival To evaluate nodal regional recurrence-free survival 10 years
Secondary Distant recurrence-free survival To evaluate distant recurrence-free survival 10 years
Secondary Disease-specific survival To evaluate disease-specific survival 10 years
Secondary Overall survival To evaluate the overall survival 10 years
Secondary Toxicities: Measurement of the rate and type of toxicity (acute and late toxic effects) To evaluate rates and type of acute and late toxicities 10 years
Secondary Cosmetic: comparison of the cosmetic result (according to both the physician and the patient) To evaluate Cosmetic results (Patient and Physician evaluations) 10 years
Secondary Quality of Life and Satisfaction To evaluate the patient quality of life and patient satisfaction 10 years
Secondary Medico-economic study To evaluate the cost of APBI compared with Standard and Hypofractionated irradiation 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT04681911 - Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A