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"Phase IV-II safety protocol, open-label , not randomized, of Myocet® in combination with Taxotere® as first line antineoplasic treatment in patients with advanced breast cancer”Protocolo de tratamiento en abierto, no aleatorizado de seguridad, en fase IV-II, con la asociación de Myocet R y Taxotere R como tratamiento antineoplásico de primera línea en pacientes con cáncer de mama avanzado

"Phase IV-II safety protocol, open-label , not randomized, of Myocet® in combination with Taxotere® as first line antineoplasic treatment in patients with advanced breast cancer”Protocolo de tratamiento en abierto, no aleatorizado de seguridad, en fase IV-II, con la asociación de Myocet R y Taxotere R como tratamiento antineoplásico de primera línea en pacientes con cáncer de mama avanzado

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002004-42-ES
Enrollment
Unknown
Registered
2005-09-02
Start date
2005-09-23
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Advanced Breast cancer

Interventions

Trade Name: Taxotere® Product Name: Taxotere® Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Docetaxel Concentration unit: mg/ml milligram(s)/millilitre Concentration

Sponsors

Grupo Oncopaz y Hospitales Asociados
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Written informed consent prior any specific protocol procedures. 2. Patients with advance breast cancer, histologically and citologically confirmed, mesurable illnesss according to RECIST criteria, do not irradiate previously 3. Women age >18 years. 4. ECOG performance status 6 months. 8. Normal cardiac function, LVEF (= 50%) with MUGA scanner or echocardiography. 9. Neutrophils =2.0x109/L, platelets =100x109/L, Hemoglobin =10g/dL. 10. Creatinine =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Previous or concomitant chemotherapy treatment for metastasic breast cancer. 2. Previous treatment with taxans 3. Pregnant or nursing women. 4. Leptomeníngeous infiltration or del central system nervous. 5. Neuropathy =G2 (NCI-CTCAE). 6. Secondary cardiovascular pathology. 7. Previous LVEF<50% or miocardical infarction. 8. Neurology or psychiatry alteration that interfers the understanding of the request of the study or the informed consent. 9. Acute or chronic active infection. 10. Activ peptic ulcer or uncontrolled diabetes mellitus. 11. Another concomitant neoplasia, except basal cell carcinoma of skin or cervix carcinoma at least 5 years befote the present trial. 12. Patients with hypersensibility to anthracyclines or ovoderivados. Patients with hypersensibility to Docetaxel. Intoleranc to excipients. 13. Another medical treatment which interferes in the study or with the drug action or confuse the study results. 14. Chronic use of corticoids, except Stara 6 months before the present trial and low dose (< 20 mg of Metilprednisolona or equivalent). 15. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 4 weeks prior to study entry.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate the safety of the combination as first line treatment, throught the cardiotoxicity rate (LVEF) in patients with advanced breast cancer, previously treated with anthracyclines as adjuvance.;Secondary Objective: Overall Response Rate Free Progression Survival, Tolerability, Time to treatment failure, Safety.;Primary end point(s): Objective cardiotoxicity rate (LVEF).—

Countries

Spain

Outcome results

None listed

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