NCT03109080

Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

A Phase I of Olaparib With Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (Triple Negative Breast Cancer) or Patient With Operated TNBC With Residual Disease

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Institut Curie · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase I of Olaparib with Radiation Therapy in Patients With Inflammatory, Loco-regionally Advanced or Metastatic TNBC (triple negative breast cancer) or Patient With Operated TNBC with Residual Disease.

Detailed description

Open label phase I, dose escalation trial for patients with triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated with residual disease (after neoadjuvant chemotherapy).

Conditions

• Breast Neoplasms, Triple-Negative
• Breast Neoplasm Malignant Female
• Radiotherapy Side Effect

Interventions

Type	Name	Description
DRUG	Olaparib	five levels of dose, per os administration, twice daily each day
RADIATION	Radiation therapy	3D conformal radiotherapy or intensity-modulated radiotherapy (IMRT), Simultaneous Integrated Boost (SIB), postoperative radiotherapy

Timeline

• Start date: 2017-07-24
• Primary completion: 2020-02-17
• Completion: 2021-11-29
• First posted: 2017-04-12
• Last updated: 2025-11-24

Locations

1 site across 1 country: France