Refractory ER-positive metastatic breast cancer MedDRA version: 14.1 Level: PT Classification code 10055113 Term: Breast cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: YONDELIS*EV 1FL POLV 1MG
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: TRABECTEDIN
CAS Number: 114899-77-3
Concentration unit: µg/m2 microgram(s)/square
Sponsors
FONDAZIONE SALVATORE MAUGERI - CLINICA DEL LAVORO E DELLA RIABILITAZIONE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Signed, informed consent 2.Histologically or cytologically confirmed ER positive breast cancer refractory to standard therapy or for which no standard therapy exists 3.Recovered from all acute adverse effects of prior therapies (excluding alopecia and grade 1 neuropathy) 4.Adequate bone marrow, hepatic and renal function including the following a.Hb = 9.0 g/dL, absolute neutrophil count = 1.5 x 109/L, platelets =100 x 109/L b.Total bilirubin = 1.5 x upper normal limit, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome c.AST (SGOT), ALT (SGPT) = 2.5 x upper normal limit (or 5x UNL in the presence of liver metastases) d.Creatinine = 1.5 x upper normal limit 5.Age = 18 years 6.Performance status (PS) = 2 (ECOG scale) 7.Estimated life expectancy greater than 3 months 8.Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment. Acceptable methods of contraception include IUD, oral contraceptive, subdermal implant and double barrier (condom with a contraceptive sponge) Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: 1.Anti-cancer therapy including chemotherapy, radiotherapy, endocrine therapy, immunotherapy or use of other investigational agents within the 4 weeks prior to trial entry (or a longer period depending on the defined characteristics of the agents used e.g. 6 weeks for mitomycin or nitrosourea, 3 months for antibodies). In patients with progressive disease, bisphosphonates for bone disease and corticosteroids are permitted provided the dose does not change during the trial 2.Patients with a prior allogeneic haematopoietic stem cell transplant 3.Co-existing active infection or serious concurrent illness 4.Patients with significant cardiovascular disease as defined by: a.LVEF below the normal range at the study centre b.Uncontrolled hypertension c.A history of QTc abnormalities or with a mean QTc interval >450 msec at screening 5.Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk 6.Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies 7.Gastrointestinal disorders that may interfere with absorption of the study drug. 8.Patients with known brain tumours or metastases should be excluded from this clinical trial because of their poor prognosis 9.More than 6 prior chemotherapy regimens 10.Patients requiring palliative radiotherapy within the last 4 weeks prior to study entry 11.Uncontrolled hypercalcaemia (>CTCAE v3 grade I) 12.Pregnant or breast-feeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of I3C when administered orally to patients receiving T for refractory ER-positive metastatic breast cancers, focusing on the potential modulation of T-induced hepatotoxicity;Secondary Objective: To compare pharmacokinetic parameters of T when given in combination with I3C at different doses. To perform a preliminary assessment of the anti-tumour activity of T and I3C combination in ER-positive metastatic breast cancer.;Primary end point(s): 1. Hepatotoxicity through liver function control 2. Evaluation of hematologic and nonhematologic toxicities according to CTCAE version 3.0 criteria;Timepoint(s) of evaluation of this end point: Every 28 days during treatment and every 3 months after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Measurement of T plasma concentration according to measures of pharmacokinetics during the first 2 cycles of treatment 2. Antitumor efficacy evaluation according to RECIST criteria after 3 and 6 cycles of treatment or whenever in the case of clinical progression;Timepoint(s) of evaluation of this end point: 1 T0 2 1 min before the end of the 3 hours infusion 3 0.5 h after the end of infusion 4 1 h after the end of infusion 5 2 h after the end of infusion 6 6 h after the end of infusion “ “ 7 10-12 h after the end of infusion 8 24 h after the end of infusion 9 48 h after the end of infusion 10 72 h after the end of infusion ______________________________________ Antitumor efficacy evaluation according to RECIST criteria after the 3rd and 6th course of treatment or whenever in case of clinical progression | — |
Countries
Italy
Contacts
Public ContactUo Oncologia Medica I
Fondazione Salvatore Maugeri, IRCCS
Outcome results
None listed