Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy

Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy - SUBITO

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-002493-13-NL

Enrollment

174

Registered

2016-09-15

Start date

2016-09-15

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

High risk breast cancer (stage III), BRCA1-like MedDRA version: 19.0 Level: PT Classification code 10006201 Term: Breast cancer stage III System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Doxorubicin Product Name: Doxorubicin Pharmaceutical Form: Solution for infusion INN or Proposed INN: DOXORUBICIN CAS Number: 23214-92-8 Concentration unit: mg/m2 milligram(s)/square meter

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • =18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Previous radiation therapy • Previous chemotherapy • Previous treatment with a PARP-inhibitor, including olaparib • A history of uncontrolled seizure disorder • Pre-existing neuropathy from any cause in excess of Grade 1 • Known history of allergic reaction to cremophor/paclitaxel • Clinically significant uncontrolled condition(s)

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate whether (neo)adjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mini-CTC) compared to AC-CP chemotherapy followed by 1-year olaparib monotherapy substantially improves overall survival (OS) in stage III BRCA1-like breast cancer patients.;Secondary Objective: • To compare the toxicity* between the treatment arms • To investigate whether (neo)adjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mini-CTC) compared to the AC-CP-olaparib regimen substantially improves recurrence-free survival (RFS) • To investigate the relevance of putative biomarkers for resistance to mini-CTC chemotherapy schedule, such as XIST gene and 53BP1 protein expression • To investigate potential heterogeneity in efficacy regarding mini-CTC treatment versus the standard-dosed regimen for the following factors:• To identify novel putative biomarkers for mini-CTC and the AC-CP-olaparib regimen • To investigate cost-effectiveness of mini-CTC compared to the AC-CP-olaparib regimen • To investigate patient reported outcomes, including quality of life and neuro-cognitive functioning of patients treated with mini-CTC compared to the AC-CP-olaparib regimen ;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Follow up for 10 years	—

Measure

Time frame

Main Objective: To investigate whether (neo)adjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mini-CTC) compared to AC-CP chemotherapy followed by 1-year olaparib monotherapy substantially improves overall survival (OS) in stage III BRCA1-like breast cancer patients.;Secondary Objective: • To compare the toxicity* between the treatment arms • To investigate whether (neo)adjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mini-CTC) compared to the AC-CP-olaparib regimen substantially improves recurrence-free survival (RFS) • To investigate the relevance of putative biomarkers for resistance to mini-CTC chemotherapy schedule, such as XIST gene and 53BP1 protein expression • To investigate potential heterogeneity in efficacy regarding mini-CTC treatment versus the standard-dosed regimen for the following factors:• To identify novel putative biomarkers for mini-CTC and the AC-CP-olaparib regimen • To investigate cost-effectiveness of mini-CTC compared to the AC-CP-olaparib regimen • To investigate patient reported outcomes, including quality of life and neuro-cognitive functioning of patients treated with mini-CTC compared to the AC-CP-olaparib regimen ;Primary end point(s): Overall survival;Timepoint(s) of evaluation of this end point: Follow up for 10 years

—

Secondary

Measure	Time frame
Secondary end point(s): - recurrence free interval - (non) hematological toxicity;Timepoint(s) of evaluation of this end point: - recurrence free interval; follow up for 10 years - toxicity; evaluation after every cycle of chemotherapy	—

Countries

Netherlands

Contacts

Public ContactStudy Coordinator

NKI-AVL

s.vliek@nki.nl

Outcome results

None listed

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