Study of the medicinal product Trabectedin in Patients with AdvancedBreast Carcinoma.
- Conditions
- Advanced Breast CarcinomaMedDRA version: 14.0Level: LLTClassification code 10006204Term: Breast carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022968-13-BE
- Lead Sponsor
- Pharma Mar, S.A. Sociedad Unipersonal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
1. Age = 18 years.
2. Voluntary written informed consent, obtained from the patient before the beginning of any specific study procedures.
3. Histologically proven diagnosis of advanced or MBC.
4. Patients must be HER2 negative and hormone receptors (estrogen receptor and/or progesterone receptor) positive.
5. Failure to at least two but no more than five chemotherapy lines in the advanced setting.
6. Previous treatment with anthracyclines or taxanes.
7. XPG RNA expression determined from patient's tumor specimen (paraffinembedded tissue).
8. Measurable disease as defined by the RECIST v.1.1. If the only tumor lesion is situated in a previously irradiated area, or in an area subjected to other locoregional therapy, progression in the lesion must be demonstrated.
9. Patients with bone metastases currently receiving bisphosphonates for palliation will be eligible if other sites of measurable disease are present.
10. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 (see Appendix 1).
11. Adequate bone marrow, liver and kidney function:
a. Hemoglobin = 9g/dl.
b. Neutrophil count = 1.5×109/l.
c. Platelet count = 100×109/l
d. Serum creatinine = 1.5 mg/dl or calculated creatinine clearance = 30 ml/min.
e. Albumin =2.5g/dl.
f. Total serum bilirubin = upper limit of normal (ULN), except in case of Gilbert's syndrome.
g. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =3×ULN.
h. Total alkaline phosphatase (AP) =2.5×ULN; if the value is >2.5×ULN, evaluate the hepatic AP isoenzyme and/or gamma-glutamyltransferase (GGT) and/or 5'nucleotidase, which values must be within the ULN (this indicates that the elevation of AP was of bone origin).
i. Creatine phosphokinase (CPK) =2.5×ULN.
12. Life expectancy =3 months.
13. Complete recovery to grade = 1 from any toxicity due to previous therapy (except for alopecia and grade 2 neuropathy).
14. Women of child-bearing potential must have a negative pregnancy test prior to the treatment initiation and use a medically approved method of contraception during treatment with the trial medication and for three months after the last
administration of the study drug. Fertile men must use a medically approved method of contraception during the treatment with the trial medication and for five months after the last administration of the study drug.
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 32
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
Patients fulfilling any of the following criteria will not be included into
the trial:
1. Prior exposure to trabectedin.
2.Treatment with chemotherapy or with biological agents in the two
weeks prior to the first dose of the clinical trial drug (six weeks for
nitrosoureas or mitomycin C) provided that patients have recovered to
grade = 1 from any toxicity due to prior therapy (except alopecia and
grade 2 neuropathy)(see inclusion criterion 13).
3. Participation in another clinical trial, or concomitant treatment with
any investigational drug, in the four weeks prior to enrollment in the
clinical trial.
4. Concomitant administration of any other antineoplastic therapy.
5. Contraindications to corticosteroid use.
6. History of another neoplastic disease (except for basal cell carcinoma of the skin or properly treated carcinoma in situ of the uterine cervix) unless in remission for five years or longer.
7. Presence of cerebral and/or leptomeningeal metastasis, even if they
are being treated.
8. Other serious and/or relevant diseases or clinical situations that, in
opinion of the Investigator, are incompatible with the protocol (any of the following):
a. History of cardiac disease, such as myocardial infarction, in the year
prior to enrollment in the clinical trial; symptomatic/uncontrolled angina
pectoris; congestive heart failure or uncontrolled cardiac ischemia; any
type of uncontrolled arrhythmia or abnormal left ventricular ejection
fraction, or uncontrolled arterial hypertension (according to the
standards of the World Health Organization [WHO]).
b. History of significant psychiatric disease.
c. Active infection requiring antibiotic, antifungal or antiviral treatment
that, in the opinion of the Investigator, could compromise the patient's capacity to tolerate the therapy.
d. Active liver (hepatitis B or C) or renal disease.
e. Major surgery in the two weeks prior to entering the clinical trial, or
any other concomitant pathology that could jeopardize the patient's safety or commitment to complete the clinical trial.
9. Pregnant or breastfeeding women (negative pregnancy test in the
three days prior to treatment administration required).
10. Inability or refusal to comply with the protocol or with the clinical
trial procedures.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method