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Brief Title: Breast-Conserving Therapy Compared With Mastectomy Followed By Radiation Therapy in Treating Women With Locally Advanced Breast Cancer Previously Treated With Chemotherapy
Official Title: Conservative Local Treatment Versus Mastectomy After Induction Chemotherapy In Locally Advanced Breast Cancer: A Randomized Phase III Study
Study ID: NCT00028704
Brief Summary: RATIONALE: Breast-conserving treatments such as radiation therapy or limited surgery are less invasive than mastectomy and may improve the quality of life. It is not yet known if breast-conserving treatments are as effective as mastectomy followed by radiation therapy in treating locally advanced breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of breast-conserving therapy with mastectomy followed by radiation therapy in treating women who have locally advanced breast cancer that has been previously treated with chemotherapy.
Detailed Description: OBJECTIVES: * Compare the overall survival and time to loco-regional failure in women with locally advanced breast cancer treated with breast-conserving local therapy vs mastectomy followed by radiotherapy after they have received prior induction chemotherapy. * Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, initial stage (T0, T1, T2, T3, or Tx vs T4), response to prior induction chemotherapy (complete response (CR) vs other), and menopausal status (premenopausal vs postmenopausal). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo mastectomy followed by radiotherapy. * Arm II: Patients receive breast-conserving treatment comprising 1 of 3 of the following therapeutic options: * Regimen A: Patients receive radiotherapy alone. * Regimen B: Patients with a partial response (PR) to prior induction chemotherapy undergo limited surgery followed by radiotherapy. Patients with a CR to prior induction chemotherapy undergo radiotherapy alone. * Regimen C: Patients with a partial response (PR) or CR to prior induction chemotherapy undergo radiotherapy alone. Patients with a CR to radiotherapy receive no further treatment. Patients with a PR to radiotherapy undergo limited surgery. Quality of life is assessed at baseline, at the end of therapy, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. Patients are followed within 1 month, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,300 patients (650 per treatment arm) will be accrued for this study within 5 years.
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Centre Hospitalier Etterbeek Ixelles, Brussels, , Belgium
U.Z. Gasthuisberg, Leuven, , Belgium
Instituto de Radiomedicina, Santiago, , Chile
Rambam Medical Center, Haifa, , Israel
Akademisch Medisch Centrum, Amsterdam, , Netherlands
Arnhems Radiotherapeutisch Instituut, Arnhem, , Netherlands
Leiden University Medical Center, Leiden, , Netherlands
Dr. Bernard Verbeeten Instituut, Tilburg, , Netherlands
Medical University of Gdansk, Gdansk, , Poland
Karol Marcinkowski University, Poznan, , Poland
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, , Poland
Hospitais da Universidade de Coimbra (HUC), Coimbra, , Portugal
Charing Cross Hospital, London, England, United Kingdom
Name: Jacek Jassem, MD, PhD
Affiliation: Medical University of Gdansk
Role: STUDY_CHAIR
Name: G. van Tienhoven, MD, PhD
Affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Role: STUDY_CHAIR
Name: Marzena Welnicka-Jaskiewicz, MD
Affiliation: Medical University of Gdansk
Role: STUDY_CHAIR
Name: Rodrigo Arriagada, MD
Affiliation: Instituto de Radiomedicina
Role: STUDY_CHAIR
Name: Marie Emson, BSc
Affiliation: International Collaborative Cancer Group
Role: STUDY_CHAIR