Pilot study of sequential adjuvant chemotherapy regimen including non-pegylated Liposomal Doxorubicin (MYOCET) in combination with Cyclophosphamide and Paclitaxel in elderly patients with diagnosis of early breast cancer (COLT-ONE study).

Pilot study of sequential adjuvant chemotherapy regimen including non-pegylated Liposomal Doxorubicin (MYOCET) in combination with Cyclophosphamide and Paclitaxel in elderly patients with diagnosis of early breast cancer (COLT-ONE study). - COLTONE

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-024067-41-IT

Enrollment

Registered

2011-12-12

Start date

2011-04-28

Completion date

Unknown

Last updated

2025-03-03

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

Conditions

Elderly patients with diagnosis of early breast Cancer candidate to adjuvant chemotherapy. MedDRA version: 14.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: MYOCET Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg/m2 milligram(s)/square meter Concentration number: 60- Pha

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histological breast cancer diagnosis with stage I-III; positive axillary lymph-node or negative axillary lymph-nodes but at high risk for at least one of the following features: high nuclear grade, negative hormone receptors, high Ki-67; ECOG 0-1;age = 65 years; adequate Kidney function: creatininemia 65 ml/min;adequate liver function:bilirubin 10 mg/dl, neutrophils > 1,8 x 109/L,plates > 100 x 109/L;normal left ventricular ejection fraction(F.E. more than 50%);written informed assent. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: 1)co-presence of relevant clinical diseases ;2)previous cardiac events (angina Pectoris or Acute Myocardium Infarct;Cardiac Unbalance;Cardiomyopathy's History ;Cardiac Arrhythmy in treatment;alteration of the cardiac electrical managment which compromised cardiac function or that requires specific treatments;alteration of the cardiac valvular function which compromises the cardiac functionality or that requires specific treatments;cardiomegaly; not controlled hypertension; 3)overexpression of HER2-NEU; 4)previous chemoterapeutic treatments; 5)presence of metabolic scompensate disease or infections.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary end point of the study is to evaluate the feasibility of a sequential adjuvant chemotherapy regimen including non-pegylated Liposomal Doxorubicin(Myocet)in combination with Cyclophosphamide and Paclitaxel, in terms of observed cardiovascular events of any grade of NCI scale (National Cancer Institute Common Toxicity Criteria) since two years from beginning of the treatment.;Secondary Objective: Evaluate quality of life of this elderly population by the use of a validated test (EORTC QLQ-c30).;Primary end point(s): safety	—

Measure

Time frame

Main Objective: The primary end point of the study is to evaluate the feasibility of a sequential adjuvant chemotherapy regimen including non-pegylated Liposomal Doxorubicin(Myocet)in combination with Cyclophosphamide and Paclitaxel, in terms of observed cardiovascular events of any grade of NCI scale (National Cancer Institute Common Toxicity Criteria) since two years from beginning of the treatment.;Secondary Objective: Evaluate quality of life of this elderly population by the use of a validated test (EORTC QLQ-c30).;Primary end point(s): safety

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Countries

Italy

Contacts

Public ContactUfficio Sperimentazioni Cliniche

U.O. Oncologia Medica

seg.scie-onco@usl5.toscana.it0587-098707

Outcome results

None listed

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