A prospective, Belgian multi-center, single-arm, phase II study consists in a pre-surgery weekly paclitaxel and carboplatin chemotherapy treatment followed by epirubicin and cyclophosphamide chemotherapy treatment on the 2 weeks at patients with stage II and III sormono-sensitive breast cancer.

A prospective, Belgian multi-center, single-arm, phase II study of neoadjuvant weekly paclitaxel and carboplatin followed by dose dense epirubicin and cyclophosphamide in stage II and III triple negative breast cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003723-21-BE

Enrollment

Registered

2015-02-06

Start date

2015-05-27

Completion date

Unknown

Last updated

2022-03-28

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

Conditions

Stage II and III triple negative breast cancer patients suitable for preoperative chemotherapy

Interventions

Trade Name: Carboplatin Product Name: Carboplatin Product Code: L01XA02 Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: Carboplatin CAS Number: 41575-94-4 C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Stage II-III operable triple negative (ER and PR 18. For patients aged 65 or older the G8 geriatric screening test should be > 14 (on a total of 17). - Baseline mammography, US. MR of the breast on clinical indication. - FNA of suspicious axillary lymph node is indicated - Pre-treatment SN biopsy is indicated in clinical N0 - Measurable loco-regional disease - Adequate bone marrow function, defined as o Absolute neutrophil count(ANC) >1500*109/L o Platelet count >100.000*109/L - Adequate liver function defined as o Serum(total) bilirubin 55% - Creatinine clearance > 40 ml/min according to local laboratory standard (MDRD, CDK-epi, Cockroft-Gault, or other established formula to calculate renal function) 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 63 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 63

Exclusion criteria

Exclusion criteria: - T4d breast tumor - Bilateral breast cancer - Other invasive cancer in the past except for a localized squamous cell cancer or basal cell of the skin or an in situ squamous cell cancer of the cervix.

Design outcomes

Primary

Measure	Time frame
Main Objective: - To determine the rate of pCR in the breast and axilla (ypT0/is, ypN0). Pathological complete response is defined as no presence of invasive residuals in the breast and resected axillary lymph nodes. ;Secondary Objective: - To evaluate the toxicity of the study regimen - To evaluate the drug delivery - To evaluate clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla. - To evaluate breast-conserving surgery rate - To evaluate progression free survival - To evaluate overall survival - To evaluate the percentage of patients with BRCA1, BRCA2, or CHEK2 mutation in this population. - To evaluate tumor infiltrating lymphocytes on the residual tumor - To do genome analysis on tissue samples;Primary end point(s): - The rate of pCR in the breast and axilla (ypT0/is, ypN0);Timepoint(s) of evaluation of this end point: After surgery when part 1 and 2 of treatment are ended	—

Measure

Time frame

Main Objective: - To determine the rate of pCR in the breast and axilla (ypT0/is, ypN0). Pathological complete response is defined as no presence of invasive residuals in the breast and resected axillary lymph nodes. ;Secondary Objective: - To evaluate the toxicity of the study regimen - To evaluate the drug delivery - To evaluate clinical response rate (RECIST 1.1) by mammography and sonography in breast and axilla. - To evaluate breast-conserving surgery rate - To evaluate progression free survival - To evaluate overall survival - To evaluate the percentage of patients with BRCA1, BRCA2, or CHEK2 mutation in this population. - To evaluate tumor infiltrating lymphocytes on the residual tumor - To do genome analysis on tissue samples;Primary end point(s): - The rate of pCR in the breast and axilla (ypT0/is, ypN0);Timepoint(s) of evaluation of this end point: After surgery when part 1 and 2 of treatment are ended

—

Secondary

Measure	Time frame
Secondary end point(s): - Safety - The drug delivery - Clinical response rate - Rate of breast conserving surgery - PFS - OS - Percentage of patients with BRCA1, BRCA2, or CHEK2 mutation in this population - Percentage of tumor infiltrating lymphocytes on residual tumor - Subsequent genomic studies on the tumor and germline DNA's;Timepoint(s) of evaluation of this end point: during and after part 1 and 2 of treatment	—

Measure

Time frame

Secondary end point(s): - Safety - The drug delivery - Clinical response rate - Rate of breast conserving surgery - PFS - OS - Percentage of patients with BRCA1, BRCA2, or CHEK2 mutation in this population - Percentage of tumor infiltrating lymphocytes on residual tumor - Subsequent genomic studies on the tumor and germline DNA's;Timepoint(s) of evaluation of this end point: during and after part 1 and 2 of treatment

—

Countries

Belgium

Contacts

Public ContactDr. Fontaine

UZ Brussel

christel.fontaine@uzbrussel.be+322477.64.15

Outcome results

None listed

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