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.
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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
five levels of dose, per os administration, twice daily each day
3D conformal radiotherapy or intensity-modulated radiotherapy (IMRT), Simultaneous Integrated Boost (SIB), postoperative radiotherapy
Institut Curie
Paris, France
Determination of the Maximal Tolerated Dose of Olaparib administered with concurrent loco regional radiotherapy
Incidence of early Dose Limited Toxicity (DLTs: early adverse effects related to Olaparib administered with concurrent radiotherapy) to determinate the Maximal Tolerated Dose (MTD) of Olaparib administered with concurrent loco regional radiotherapy in patients who have triple negative inflammatory, loco-regional advanced or metastatic breast cancer either inoperable after neoadjuvant chemotherapy or operated patient with residual disease (after neoadjuvant chemotherapy).
Time frame: 2 years
Incidence of Serious Adverse Events (SAEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of Serious Adverse Events (SAEs), graded according to NCI-CTCAE version 4.03 criteria
Time frame: 2 years
Incidence and severity of Adverse Events (AEs), graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence and severity of Adverse Events (AEs), graded according to NCI-CTCAE version 4.03 criteria
Time frame: 2 years
Incidence and severity of laboratory abnormalities, graded according to NCI-CTCAE version 4.03 criteria to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence and severity of laboratory abnormalities, graded according to NCI-CTCAE version 4.03 criteria
Time frame: 2 years
Incidence of acute toxicity 2 weeks and 6 weeks after the end of radiotherapy to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of acute toxicity 2 weeks and 6 weeks after the end of radiotherapy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 2 years
Incidence of late toxicity at 1 year and at 2 years as of initiation of radiation therapy to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of late toxicity at 1 year and at 2 years as of initiation of radiation therapy
Time frame: 2 years
Incidence of treatment discontinuations and treatment modifications due to AEs to assess the safety profile of Olaparib administered with concurrent loco-regional radiotherapy.
Incidence of treatment discontinuations and treatment modifications due to AEs
Time frame: 2 years
Evaluation of the Objective Response Rate (ORR) to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of the Objective Response Rate (ORR) to treatment
Time frame: 2 years
Evaluation of the Complete Response Rate to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of the Complete Response Rate to treatment
Time frame: 2 years
Evaluation of Pathological Response Rate (pRR) after salvage surgery to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of Pathological Response Rate (pRR) after salvage surgery
Time frame: 2 years
Evaluation of the loco-regional Progression Free Survival (l-PFS) to evaluate Olaparib administered with concurrent loco regional radiotherapy efficacy profile
Evaluation of the loco-regional Progression Free Survival (l-PFS)
Time frame: 2 years
Evaluation of the Progression Free Survival (PFS) or Disease Free survival (DFS) according to stage of disease to evaluate patient outcome
Evaluation of the Progression Free Survival (PFS) or Disease Free survival (DFS)
Time frame: 2 years
Evaluation of the distant relapse rate to evaluate patient outcome
Evaluation of the distant relapse rate
Time frame: 2 years
Evaluation of patient outcome by evaluation of the Overall Survival (OS).
Evaluation Overall Survival (OS).
Time frame: 2 years
Evaluation of patient outcome by evaluate disease specific survival rate.
Evaluation of the disease specific survival rate.
Time frame: 2 years
Explore biomarkers of Olaparib activity in combination with concurrent radiotherapy.
Exploration of biomarkers of Olaparib associated with radiotherapy on biopsies.
Time frame: 2 years