Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer

Titre officiel

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiation Therapy Versus Radiation Therapy Alone for Inflammatory Breast Cancer

Sommaire:

Cet essai de phase II évalue la mesure dans laquelle la radiothérapie avec ou sans olaparib est efficace pour traiter des patientes atteintes d’un cancer du sein inflammatoire. La radiothérapie administre des rayons X à haute énergie afin de tuer les cellules tumorales et de réduire la taille des tumeurs. L’olaparib pourrait stopper la croissance des cellules tumorales en bloquant certaines enzymes nécessaires à la croissance cellulaire. On ne sait pas encore si la radiothérapie avec ou sans olaparib serait plus efficace dans le traitement du cancer du sein inflammatoire.

Description de l'essai

Primary Outcome:

  • Invasive Disease-Free Survival (IDFS)
Secondary Outcome:
  • Locoregional Recurrence-Free Interval (Local Disease-Free Interval [LDFI])
  • Distant Relapse-Free Survival (Distant Recurrence-Free Survival)
  • Overall Survival
PRIMARY OBJECTIVE: I. To compare the invasive disease-free survival (IDFS) of patients with inflammatory breast cancer receiving concurrent administration of olaparib with standard doses of radiation therapy to the chest wall and regional lymph nodes compared to standard doses of radiation therapy alone to the chest wall and regional lymph nodes. SECONDARY OBJECTIVE: I. To compare the effect of concurrent administration of olaparib with radiation therapy versus radiation therapy alone on improvement in locoregional control (measured by locoregional recurrence-free interval), distant relapse-free survival, and overall survival in inflammatory breast cancer patients. ADDITIONAL OBJECTIVE: I. To collect tissue and whole blood for processing and banking in anticipation of future correlative studies in this patient population. OUTLINE:

Patients are randomized to 1 of 2 groups. GROUP I: Patients receive olaparib orally (PO) twice daily (BID) the day before standard radiation therapy (RT) commences (Day 0) and throughout the RT course until the last day of RT administration. Olaparib is also continued on weekends (routine days without RT) throughout the RT course. Patients undergo radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unaccepted toxicity. GROUP II: Patients undergo standard radiation therapy 5 days per week for 6 weeks in the absence of disease progression or unaccepted toxicity. After completion of study treatment, patients are followed up within 5 weeks, then every 3 months until 3 years after registration, and then every 6 months for up to 8 years after registration.

Voir cet essai sur ClinicalTrials.gov

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