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Reinduction with liposomal anthracyclines and Capecitabine in patients with breast cancer, locally advanced (IIIA-IIIB-IIIC) HER2 negative, not obtaining a pathological complete response (<PCR) after primary chemotherapy. - ICARO 2

Reinduction with liposomal anthracyclines and Capecitabine in patients with breast cancer, locally advanced (IIIA-IIIB-IIIC) HER2 negative, not obtaining a pathological complete response (<PCR) after primary chemotherapy. - ICARO 2

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011756-22-IT
Enrollment
Unknown
Registered
2009-06-18
Start date
2009-10-05
Completion date
Unknown
Last updated
2012-04-03

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

Conditions

Population of female patients suffering from breast cancer in initial clinical stage IIIA, IIIB and IIIC not expressing HER2 and who have not obtained a pathological complete response (defined <PCR) after neoadjuvant chemotherapy MedDRA version: 12.0 Level: LLT Classification code 10006283 Term: Breast neoplasm malignant female

Interventions

Trade Name: MYOCET Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Doxorubicin Concentration unit: mg milligram(s) Concentration type: equal Concentration number

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patient with residual disease on breast and / or axillary lymph nodes (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: History of cancer in the previous 10 years (except skin cancer non-melanoma or cervical carcinoma in situ radically excised). - More serious illnesses. - Chronic renal failure - Congestive heart failure or angina pectoris even if controlled. Previous history of myocardial infarction, uncontrolled hypertension, or arrhythmia. - History of psychiatric or neurological disorders including dementia and epilepsy. - Infection in place. - Treatment with other experimental drugs. - Geographical inaccessibility to treatment and follow up. - Pregnancy or lactation

Design outcomes

Primary

MeasureTime frame
Main Objective: Disease free survival(DFS)at 3 years;Secondary Objective: The overall survival (OS), toxicity, compliance and adherence to protocol;Primary end point(s): - Assessment of effectiveness in the short to medium term (3 years) of DFS and OS - Assessment of the feasibility to perform the treatment of reinduzione after 6 months from completion of adjuvant chemotherapy—

Countries

Italy

Outcome results

None listed

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