Locally advanced breast cancer MedDRA version: 21.1 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Olaparib
Product Code: AZD2281
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Olaparib
CAS Number: 763113-22-0
Current Sponsor code: AZD2281
Other descriptive name: olaparib
Con
Sponsors
AZIENDA OSPEDALIERA "ISTITUTI OSPITALIERI" DI CREMONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients (female) must be 18 years of age. - Germline BRCA1 or BRCA2 mutation that is considered deleterious or suspected deleterious for the control arm. - Measurable disease according to RECIST criteria v. 1.1. - ECOG performance status 0-1. - Patient able to swallow and maintain oral caps. - Patients must have a life expectancy = 16 weeks. - Non-childbearing or breast feeding patients. Female patient of childbearing potential must have a negative serum pregnancy test (ß-human chorionic gonadotropin [ß-hCG]) within 72 hours prior to the first dose). Patients of child bearing potential and their partners with whom they are sexually active must agree to the use of 2 highly effective forms of contraception from the allocation into the study, throughout the study and until 3 months after the last dose of study drug. Women are considered of childbearing potential if they are not post-menopausal, free from menses for > 1 year or surgically sterilized. - Absence of psychological, familiar, sociologic or geographic conditions that may interfere with study protocol adherence and follow-up program. These conditions must be discussed with the patient before the entry into the study. - Patients should acknowledge that they are at an increased risk of infection with conventional chemotherapy drugs and since the effects with Olabarib are unknown they must accept that live virus and bacterial vaccines should not be administered to them for the duration of the study and for 3 months after last dose of study medication. If patients are blood donors they should accept not to donate blood during the study and for 3 months after the last dose of study drug. - Patients must have voluntarily agreed to participate by given informed consent. Written informed consent must be dated and signed by both patients and investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: - Previous enrolment in the present study - Participation in another clinical study with an investigational product during the last 12 months - Any previous treatment with a PARP inhibitor, including olaparib. - Patients with-out any sign or symptoms of distant metastases. - Major surgery within 14 days of starting study treatment and patients must have recovered from any effects of any major surgery. - Patients considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled infection. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3 months) myocardial infarction, unstable spinal cord compression (untreated and unstable for at least 28 days prior to study entry), superior vena cava syndrome, extensive bilateral lung disease on HRCT scan or any psychiatric disorder that prohibits obtaining informed consent. - Immunocompromised patients (e.g., patients who are known to be serologically positive for human immunodeficiency virus (HIV) and are receiving antiviral therapy). - Patients with known active hepatic disease (i.e., Hepatitis B or C). - Patients with a known hypersensitivity to olaparib or any of the excipients of the product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Correlation between baseline gene and protein expression profile and clinical response evaluated after a short administration of olaparib alone at three weeks to examine baseline patterns of gene and protein expression for potential early predictors of response or non-response to the administered treatment in triple negative locally advanced breast cancer compared to all subtype of BC carrying gBRCAmut.;Secondary Objective: 1)To assess of overall response rate evaluated clinically in each treatment group. 2)To correlate between baseline mutations, gene and protein expression profile and clinical response. 3)To assess genetic and non-genetic biomarkers relating to treatment efficacy. Tumor mutations may be explored including somatic BRCA1 and 2 mutations, reversion mutations, loss of heterozygosity as well as genome landscape and transcriptional or functional measures of homologous recombination (HR) deficiency). 4)To correlate between baseline mutations, gene and protein expression profile and PET-TC Scan and/or Breast TC response after a short administration of olaparib measured at three weeks to examine baseline patterns of gene expression for potential early predictors of response or non-response to olaparib. ;Primary end point(s): Relationship between the response to treatment and biological markers;Timepoint(s) of evaluation of this end point: After 21 days and before definitive surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Best response to treatment (CR, PR, SD, and PD);Timepoint(s) of evaluation of this end point: 3 weeks | — |
Countries
Italy
Contacts
Public ContactUS Terapia Molecolare e Farmacogeno
A.O. Istituti Ospitalieri di Cremona
Outcome results
None listed