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

Sponsor
Institut Curie
Study ID
NCT03109080
Phase
PHASE1
Status
Completed

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jul 24, 2017
Status verified
Nov 2025
Primary completion
Feb 17, 2020
Completion
Nov 29, 2021

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Olaparib + radiation therapy
    One week of Olaparib alone followed by 5 weeks of Olaparib and concurrent loco-regional radiotherapy. Five levels of dose of Olaparib are expected.

Primary Outcome Measure

Determination of the Maximal Tolerated Dose of Olaparib administered with concurrent loco regional radiotherapy [ Time Frame: 2 years ]