Metastatic breast cancer during systemic therapy and in disease stability according to RECIST 1.1 criteria MedDRA version: 20.0 Level: LLT Classification code 10006216 Term: Breast carcinoma stage IV System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Bleoprim
Product Name: Bleoprim - Bleomicina
Product Code: [Bleomicina]
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Bleomicina
CAS Number: 11056-
Sponsors
ISTITUTO NAZIONALE TUMORI - IRCCS FONDAZIONE PASCALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age > 18 years • Diagnosis of histologically confirmed breast cancer with intraparenchymal breast lesion • Stability of the disease assessed at the end of three cycles of systemic therapy regardless of the type of drug according to RECIST 1.1 criteria. • Stage IV of the disease according to TNM (VIII AJCC classification) • Performance status (PS) according to (ECOG) = 2 • Signature of informed consent • Patients not randomized to other clinical trials 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 12 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: • Carcinomatous Mastitis (IBC - T4d stage) • Neutrophils <1,000 / ml • Platelets <70,000 / mL • Hemoglobin = 9 gr / dl • Known allergy to Bleomycin • Cumulative dose of Bleomycin which exceeded 250 mg/m2 • Infection in progress • Cardiac arrhythmia [severe conduction disorders such as type 2 and type 3 atrioventricular blocks and sino-atrial block] • History of Epilepsy • Pregnancy in progress • Patient unable to read or understand study documents • Patient with any disease or other significant clinical condition that, in the investigator's judgment, could interfere with the study assessments or with adequate participation in the study. • Patient in progression of the disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • Assessment of tolerability with questionnaire with a Likert scale with five options 0-5 (harmful, unbearable, hardly bearable, bearable, no problem) during the first 30 days (7-15-30 days). • Safety assessment (register of the nature and frequency of any unexpected intraoperative adverse events and related complications) within 24 hours after treatment.;Secondary Objective: • Measurement of T (size of primary tumor) in mm with breast ultrasound and mammography with contrast medium (Omnipaque 350) (CESM) 60 days after treatment. • Pain assessment with questionnaire with a Likert scale with four options 0-4 (unbearable, hardly bearable, bearable, no problem) during the first 7 days. • Assessment of the quality of life through a visual analog scale (VAS) 0-100 (poor, not very good, fairly good, very good, excellent) during the first 30 days (7-15-30 days). • Evaluation of adverse events (fever, loco-regional infection, skin necrosis, haemorrhage) during the first 30 days after treatment.;Primary end point(s): -Assessment of Tolerability Through a questionnaire with a Likert scale with five 0-5 alternatives (harmful, unbearable, hardly bearable, bearable, no problem). -Safety Assessment Register of the nature and frequency of any unexpected intraoperative adverse events and related postoperative complications within 24 hours after treatment;Timepoint(s) of evaluation of this end point: Tolerability: during the first 30 days (7-15-30 days) Safety: within 24 hours after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pain Assessment Prior to treatment and at each follow-up visit, a pain assessment will be performed using the VAS scale (visual analog scale anchored at 100 mm with 0 being "No Pain" and 100 mm "Worst Possible Pain"); Evaluation of side effects By reporting adverse events (such as fever, loco-regional infection, skin necrosis, haemorrhages) within 30 days of treatment using the classification "Common Terminology Criteria for Adverse Events Version 6.0 (CTCAE 4.0)" [https: //ctep.cancer .gov / protocolDevelopment / electronic_applications / ctc.htm].; Quality of life assessment The quality of life, measured by the QOL questionnaire, will be carried out at all controls. QOL is a tool developed in Europe and widely used, which serves to assess the general quality of life developed in Europe. The QOL descriptive system consists in expressing a preference for five parameters: mobility, self-care, usual activities, pain / discomfort and anxiety / depression. The QOL questionnaire also includes a visual analog scale (VAS), whereby respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status ).; Evaluation of effectiveness The evaluation will take place 7-15-30 days after treatment with clinical examination and 60 days with the performance of diagnostic tests (ultrasound, mammography with contrast medium (CESM) or MRI based on the diagnostic tests performed at baseline) . The measurement of T (primary tumor size) in mm will be compared with the baseline value.;Timepoint(s) of evaluation of this end point: Prior to treatment and at each follow-up visit; Within 30 days of treatment; At all check-ups; 7-15-30 days after treatment with clinical examination and 60 days with the performance of diagnostic tests | — |
Countries
Italy
Contacts
Public ContactRaimondo Di Giacomo
Istituto Nazionale Tumori di Napoli - IRCCS "G. Pascale"
Outcome results
None listed