Operated breast cancer MedDRA version: 20.0 Level: LLT Classification code 10006190 Term: Breast cancer invasive NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: CAELYX - 2 MG/ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 1 FLACONCINO 10 ML USO EV
Pharmaceutical Form: Concentrate for solution for infusion
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Operable histologically confirmed breast cancer • Luminal B HER2-negative (ER positive, HER2 negative, and at least one of the following: Ki-67 ‘high’ (=20%) or PgR ‘negative or low’) or Luminal B HER2-positive (ER positive, HER2 over-expressed or amplified, any Ki-67, any PgR) • Early-stage (pT1-3; any nodal status) • Candidate to adjuvant chemotherapy and endocrine therapy • The tumor must be confined to the breast and axillary nodes without detected metastases elsewhere • Patients with synchronous (diagnosed histologically within 2 months) bilateral invasive breast cancer are eligible if all other criteria are met • Patients must have had surgery for primary breast cancer with no known clinical residual loco-regional disease • Margins must be negative for invasive breast cancer and DCIS • Patients should be start treatment as close to definitive surgery as possible (no later than 8 weeks) • No prior neoadjuvant or adjuvant therapy for breast cancer. Note: Radiotherapy is allowed prior to trial entry. • Raloxifene, tamoxifen, or other SERM must be discontinued at least 4 weeks before trial entry. • No hormone replacement therapy (HRT). • No hormonal therapy, except steroids for adrenal failure, hormones for non-breast cancer related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic. • No treatment with bisphosphonates, except for the treatment of osteoporosis. 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 43 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: • Patients with a history of any prior ipsilateral or contralateral invasive breast cancer. • Patients with previous or concomitant malignancy diagnosed within the past five years. • Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV • Patients with myocardial infarction or pulmonary embolism within 6 months prior to trial entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate PLD (Caelyx¿) as an adjuvant chemotherapy regimen in patients with early-stage luminal B breast cancer ;Secondary Objective: ¿Adverse events, Tolerability (treatment completion), Breast cancer free interval (BCFI; events are reappearance of invasive breast cancer at any site including contralateral disease), Disease Free Survival (DFS) (includes second malignancies and deaths), Sites of failure, Second (non-breast) malignancy, Overall survival (OS), Causes of death ;Primary end point(s): The primary endpoint will be to evaluate the feasibility of adjuvant PLD (Caelyx®) for each individual subject. The regimen will be considered feasible if that subject is able to achieve relative dose intensity (RDI) of at least 85% of the 8 cycles of treatment. Relative dose intensity for each subject will be calculated as follows: (1) based on each subject's body surface area (BSA), a total planned dose for PLD (Caelyx®) calculated for a full 8-cycle regimen (planned dose, PD); (2) actual total dose of PLD (Caelyx®) for the full 8-cycle regimen as collected on the case report form (actual dose, AD); (3) overall RDI = AD/PD. ;Timepoint(s) of evaluation of this end point: 4 months from randomization of the last patient. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ¿ Adverse events ¿ Tolerability ; ¿ Breast cancer free interval (BCFI; events are reappearance of invasive breast cancer at any site including contralateral disease) ¿ Disease Free Survival (DFS) (includes second malignancies and deaths) ¿ Sites of failure ¿ Second (non-breast) malignancy ¿ Overall survival (OS) ¿ Causes of death ;Timepoint(s) of evaluation of this end point: 4 months from randomization of the last patient; 5 years | — |
Countries
Italy
Contacts
Public ContactUfficio Studi Clinici e Attivit¿ Re
Istituto Europeo di Oncologia
Outcome results
None listed