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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 21 August 2017
Main ID:  EUCTR2010-022968-13-BE
Date of registration: 04/01/2011
Prospective Registration: Yes
Primary sponsor: Pharma Mar, S.A. Sociedad Unipersonal
Public title: Study of the medicinal product Trabectedin in Patients with Advanced Breast Carcinoma.
Scientific title: Multicenter, Open-Label, Phase II Study of Trabectedin (Yondelis®) in Patients with Hormonal Receptors Positive, HER2 Negative, Advanced Breast Carcinoma, Overexpressing or Underexpressing Xeroderma Pigmentosum G Gene (XPG)
Date of first enrolment: 16/03/2011
Target sample size: 100
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2010-022968-13
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries of recruitment
Belgium Spain
Contacts
Name: Clinical Trials   
Address:  Avda de los Reyes, 1. Polígono Industrial "La Mina" 28770 Colmenar Viejo Spain
Telephone: 0034 91 8466000
Email: clinicaltrials@pharmamar.com
Affiliation:  PharmaMar S.A. Sociedad Unipersonal
Name: Clinical Trials   
Address:  Avda de los Reyes, 1. Polígono Industrial "La Mina" 28770 Colmenar Viejo Spain
Telephone: 0034 91 8466000
Email: clinicaltrials@pharmamar.com
Affiliation:  PharmaMar S.A. Sociedad Unipersonal
Key inclusion & exclusion criteria
Inclusion criteria:
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

Exclusion criteria:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Advanced Breast Carcinoma
MedDRA version: 14.0 Level: LLT Classification code 10006204 Term: Breast carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Therapeutic area: Diseases [C] - Cancer [C04]
Intervention(s)

Trade Name: Yondelis 0.25 mg powder for concentrate for solution for infusion.
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: trabectedine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.25-

Trade Name: Yondelis 1 mg powder for concentrate for solution for infusion.
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: trabectedine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-

Primary Outcome(s)
Main Objective: To evaluate the efficacy in terms of progression-free survival rate at 4 months (PFS4) of trabectedin in patients with advanced or MBC, hormonal receptors positive, HER2 negative, positive or negative for XPG overexpression, who have already received at least two lines of chemotherapy for advanced disease (including anthracyclines and taxanes).
Primary end point(s): The primary endpoint of this study is the progression-free survival rate at 16 weeks (PFS4), defined as the percentage of patients remaining alive and progression-free at Week 16 after the first treatment dose.
Secondary Objective: To compare progression-free survival (PFS), objective response rate (ORR) and duration of response (DR), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST, v.1.1) in patients positive or negative for XPG overexpression.
To compare overall survival in patients positive or negative for XPG overexpression.
Safety profile.
Timepoint(s) of evaluation of this end point: Main analysis of PFS4 will be done when 50 evaluable patients are
recruited in each XPG stratum. Futility analyses are planned once 20 evaluable patients are enrolled in each XPG stratum. Each analysis will be performed using the O'Brien Fleming boundary, after evaluable patients have had a tumor assessment at Week 16 or PD or died due to disease progression or discontinued treatment due to unmanageable toxicity, whichever occurs first. The minimum follow-up to do this analysis will be 16 weeks after the last patient recruited has received the first trabectedin infusion.
The patient’s survival will be assessed every three months.
Secondary Outcome(s)
Timepoint(s) of evaluation of this end point: Secondary endpoints (if applicable) would be assessed at the same time than primary endpoint analysis.
The planned study termination (clinical cut-off) is:
Four months after the first infusion of the last evaluable patient
recruited if the trial is stopped at the first stage.
Three months after the last infusion administered if the study proceeds into the second stage.
The patient’s survival will be assessed every three months.
Secondary end point(s): To compare progression-free survival (PFS), overall response
rate (ORR) and duration of response (DR), as defined by the
Response Evaluation Criteria in Solid Tumors (RECIST, v.1.1)
in patients positive or negative for XPG overexpression.
To compare overall survival in patients positive or negative for
XPG overexpression.
Safety profile.
Secondary ID(s)
ET-B-031-10
Source(s) of Monetary Support
Pharma Mar, S.A. Sociedad Unipersonal
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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