A phase II randomized, open-label neo-adjuvant study of standard chemotherapy regimen compared to high dose chemotherapy regimen with autologous stem cell transplantation in patients with triple negative breast cancer

A phase II randomized, open-label neo-adjuvant study of standard chemotherapy regimen compared to high dose chemotherapy regimen with autologous stem cell transplantation in patients with triple negative breast cancer - HDC with AHST in triple negative breast cancer

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-001226-25-IT

Enrollment

Unknown

Registered

2014-12-22

Start date

2015-04-20

Completion date

Unknown

Last updated

2016-06-27

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

Conditions

Triple Negative Breast Cancer patients with breast tumor >2,5 cm MedDRA version: 17.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Product Name: Epirubicin Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: EPIRUBICIN HYDROCHLORIDE CAS Number: 56390-09-1 Other descriptive name: EPIRUB

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: For inclusion in the study, patients must fulfil all of the following criteria: • Age =18 years 2,5, Any N) by physical or radiological examination. • Estrogen receptor =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • IIIB IIIC IV Stage e inflammatory breast cancer • Previous chemotherapy for early breast cancer • Any psychiatric disorder that would impair the understanding and giving of informed consent. • Male patients • Non clinical and radiological evaluable breast lesion • Pregnant or lactating patients. • History of atrial ventricular arrhythmia, congestive heart failure or angina pectoris, even if medically controlled; uncontrolled hypertension; history of 2nd or 3rd degree heart blocks. • Any history of a second neoplasm except for curatively treated non melanoma skin cancer or carcinoma in situ of the cervix. • Concomitant treatment with other anticancer drugs. • Concomitant treatment with any other experimental drug. • Patients with not adequate haematological, hepatic and renal function • Any other serious illness or medical condition

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare percentage of pathologic complete response (pCR) of the two regimens of treatments: EC (Epirubicin/Cyclophosphamide) for 4 cycles plus Docetaxel for 4 cycles (ARM A) versus ET for 4 cycles plus ETC (Epirubicin/Tiothepa/Cyclophosphamide) with AHST for 2 cycles (ARM B) among evaluable patients.;Secondary Objective: Not applicable;Primary end point(s): PRIMARY ENDPOINT To evaluate the percentage of pathologic complete response (pCR), defined as complete disappearance of invasive tumor in breast and axillary lymph-nodes. Residual ductal carcinoma in situ will be included in the pCR category. ;Timepoint(s) of evaluation of this end point: 5 months	—

Measure

Time frame

Main Objective: To compare percentage of pathologic complete response (pCR) of the two regimens of treatments: EC (Epirubicin/Cyclophosphamide) for 4 cycles plus Docetaxel for 4 cycles (ARM A) versus ET for 4 cycles plus ETC (Epirubicin/Tiothepa/Cyclophosphamide) with AHST for 2 cycles (ARM B) among evaluable patients.;Secondary Objective: Not applicable;Primary end point(s): PRIMARY ENDPOINT To evaluate the percentage of pathologic complete response (pCR), defined as complete disappearance of invasive tumor in breast and axillary lymph-nodes. Residual ductal carcinoma in situ will be included in the pCR category. ;Timepoint(s) of evaluation of this end point: 5 months

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Secondary

Measure	Time frame
Secondary end point(s): SECONDARY ENDPOINTS • To evaluate the percentage of breast clinical objective responses; • To test the percentage of conservative surgery; • To evaluate the percentage of inhibition of intermediate and final biomarkers of the proliferative and the apoptosis pathways induced by the different combinations; • To analyse the correlation between gene expression at diagnosis and pathological response. • To evaluate the PFS and OS • To determine patient’s tolerability and safety of the treatment To the evaluate the Quality of Life ;Timepoint(s) of evaluation of this end point: 12 months	—

Measure

Time frame

Secondary end point(s): SECONDARY ENDPOINTS • To evaluate the percentage of breast clinical objective responses; • To test the percentage of conservative surgery; • To evaluate the percentage of inhibition of intermediate and final biomarkers of the proliferative and the apoptosis pathways induced by the different combinations; • To analyse the correlation between gene expression at diagnosis and pathological response. • To evaluate the PFS and OS • To determine patient’s tolerability and safety of the treatment To the evaluate the Quality of Life ;Timepoint(s) of evaluation of this end point: 12 months

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Countries

Italy

Contacts

Public ContactUO Hematology

ISTITUTI OSPITALIERI DI CREMONA

datamanager.ematologia@ospedale.cremona.it+390372408105

Outcome results

None listed

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