Clinical study of irinotecan weekly in patients with locally advanced or metastatic HER2-negative breast cancer and increased cancer cell copy number of the topoisomerase 1 gene”

Phase II study of irinotecan weekly in patients with locally advanced or metastatic HER2-negative breast cancer and increased cancer cell copy number of the topoisomerase 1 gene (TOP1)” - NEGIRI

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-002348-26-DK

Enrollment

Registered

2012-06-26

Start date

2012-08-20

Completion date

Unknown

Last updated

2016-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer MedDRA version: 17.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864

Interventions

Trade Name: irinotecan Product Name: Irinotecan Pharmaceutical Form: Infusion INN or Proposed INN: IRINOTECAN CAS Number: 97682-44-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histological or cytological confirmed adenocarcinoma of the breast MBC with = 4 TOP1 genes in the primary tumour. Age › 18 Performance status 0-2 Locally advanced or metastatic disease HER2 negative disease Measurable disease by RECIST 1.1 Maximum 4 prior chemotherapy regiments for locally advanced or metastatic disease Neutrophil count (ANC) = 1,5 x 10?/l and platelet count = 100 x 10?/l Serum bilirubin = 1.5 x ULN Serum transaminases = 2.5 x ULN Written informed consent 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Other present or previous malignancy except curatively treated cervical cancer stage I or non-melanotic skin cancer Cytotoxic or experimental treatment 2 weeks prior to inclusion Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory. Fertile patients not willing to use IUD as an acceptable and safe method of contraception CNS metastasis Allergy to the ingredients of the study medication. Patients who due to linguistic, culturel or incelectual reasons do not understand the protocol information Any condition or therapy that in the opinion of the investigator will put the patient at risk Patients with ongoing infections or other serious concomitant medical conditions that could interfere with the treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1;Secondary Objective: Progression free survival Overall survival toxicity.;Primary end point(s): Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1;Timepoint(s) of evaluation of this end point: Every 6 weeks	—

Measure

Time frame

Main Objective: Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1;Secondary Objective: Progression free survival Overall survival toxicity.;Primary end point(s): Clinical benefit rate defined as the fraction of patients with stable disease >= 4 months, complete or partial response according to RECIST 1.1;Timepoint(s) of evaluation of this end point: Every 6 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): Progression free survival Overall survival toxicity.;Timepoint(s) of evaluation of this end point: PFS: from first treatment date to progression or death Overall Survival: from first treatment date to death of any cause Toxicity: at every clinical control	—

Countries

Denmark

Contacts

Public ContactDepartment of Oncology

Herlev Hospital

iben.kumler@regionh.dk004538689598

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026