|
Main
|
|
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:
|
8 October 2021 |
|
Main ID: |
EUCTR2007-000794-31-FR |
|
Date of registration:
|
07/06/2007 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in
Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-),
HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers
|
|
Scientific title:
|
Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) in
Metastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-),
HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers |
|
Date of first enrolment:
|
01/08/2007 |
|
Target sample size:
|
321 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-000794-31 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
|
|
Phase:
|
Human pharmacology (Phase I):
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III):
Therapeutic use (Phase IV):
|
|
|
Countries of recruitment
|
|
France
|
Italy
|
Poland
| | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
Patient´s written informed consent before any clinical trial-specific procedure.
2. Woman 18 years-of-age or older.
3. Histologically proven diagnosis of progressive metastatic breast cancer either in
documented:
• Group A: triple negative phenotype [Estrogen Receptor, Progesterone Receptor
and HER-2 negative status (surrogate of basal-like type)]. Patients will be
eligible if they had received prior therapy with an anthracycline, a taxane and
capecitabine, including adjuvant or neoadjuvant therapy, but no more than three
prior chemotherapy regimens for metastatic disease. NOTE: re-treatment with
the same regimen or its components after a progression-free interval of 6 months
or longer will be considered a second regimen.
• Group B: HER-2 overexpressing breast cancer. Patients will be eligible if they
have progressive metastatic disease following treatment with anthracyclines,
taxanes and capecitabine, with trastuzumab or other HER-2 target agent , but no
more than three prior chemotherapy regimens for metastatic disease are
allowed. NOTE: re-treatment with the same regimen or its components after a
progression-free interval of 6 months or longer will be considered as second
regimen.
• Group C: Familial BRCA1 or BRCA2 mutation carriers. Patients will be eligible if
they had received prior therapy with an anthracycline, a taxanes and
capecitabine, including adjuvant or neoadjuvant therapy, without prior lines
limitation.
4. Measurable disease as defined in the Response Evaluation Criteria in Solid
Tumors (RECIST) Guidelines. If the only indicator lesion is in a previously
irradiated area, the recurrence must be biopsy proven.
5. Patients with bone metastases currently receiving biphosphonates for palliation
will be eligible if other sites of measurable disease are present.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.
7. Hematologic variables:
• Hemoglobin =9 g/dL
• Absolute neutrophil count (ANC) =1,500/µL, and
• Platelet count =100,000/µL.
8. Serum creatinine = 1.5 mg/dL or creatinine clearance = 30 mL/min
9. Creatinine phosphokinase (CPK) = 2.5 ULN.
10. Hepatic function variables
• Total bilirubin = ULN.
• Total alkaline phosphatase = 2.5 ULN, or if > 2.5 ULN consider alkaline
phosphatase liver fraction or GGT or 5’ nucleotidase must be = ULN, if the
elevation could be osseous in origin.
• AST (serum aspartate transaminase [SGOT]) and ALT (serum alanine
transaminase [SGPT]) must be =2.5 x ULN.
11. Albumin = 25 g/l.
12. Adequately recovered from the acute toxicity of any prior treatment
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Prior exposure to trabectedin.
2. Known hypersensitivity to any of the components of the trabectedin i.v.
formulation or dexamethasone.
3. More than three prior chemotherapy regimens for metastatic disease for group A
and B. NOTE:re-treatment with the same regimen or its components after a
progression-free interval of 6 months or more is considered a second regimen.
4. Pregnant or lactating women or any women of childbearing potential who is not
employing adequate contraception. Acceptable methods of contraception include;
IUD, and double barrier (condom with a contraceptive sponge or contraceptive
suppository). Use of hormonal contraception is not acceptable during this clinical
trial.
5. Less than 4 weeks from radiation therapy or last dose of hormonal therapy,
biological therapy, therapy with any investigational agent, or chemotherapy (6
weeks if a nitrosurea or mitomycin C).
6. History of another neoplastic disease (except basal cell carcinoma or cervical
carcinoma in situ adequately treated) unless in remission for 5 years or longer.
7. Known clinically relevant CNS metastases.
8. Other serious illnesses, such as:
• Congestive heart failure or angina pectoris; myocardial infarction within 1 year
before enrollment; uncontrolled arterial hypertension or arrhythmias
• Psychiatric disorder that prevents compliance with protocol
• Active viral hepatitis; or chronic liver disease
• Active infection
• Any other unstable medical conditions
Age minimum:
Age maximum:
Gender:
Female: yes
Male: no
|
|
Health Condition(s) or Problem(s) studied
|
Progressive metastatic breast cancer previously treated in the following subpopulation of patients:
Group A: Triple negative phenotype: Estrogen Receptor, Progesterone Receptor and
HER-2 negative status (surrogate of basal-like type)
Group B: HER-2 overexpressing tumors.
Group C: Familial BRCA1 or BRCA2 mutation carriers
MedDRA version: 9.1
Level: PT
Classification code 10055113
Term: Breast cancer metastatic
|
|
Intervention(s)
|
Product Name: YONDELIS® (Trabectedin)
Product Code: ET-743
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trabectedin
CAS Number: 114899-77-3
Current Sponsor code: ET-743
Other descriptive name: Ecteinascidin 743
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0.-25
Product Name: Yondelis® (Trabectedin)
Product Code: ET-743
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: trabectedin
CAS Number: 114899-77-3
Current Sponsor code: ET-743
Other descriptive name: Ecteinascidin 743
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1.-0
|
|
Primary Outcome(s)
|
Main Objective: Primary Objective: to determine the objective response rate by RECIST (Complete and Partial Response [CR + PR]) with trabectedin in patients with the following metastatic
breast cancer subtypes:
Group A: triple negative profile (ER-,PR-,HER-2-)
Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-2+)
Group C: familial BRCA1 or BRCA2 mutation carriers
|
Secondary Objective: To assess in each group:
• Duration of response
• Progression-free survival
• Exploratory evaluation of changes in tumor volume (three dimensional
analysis) and changes in tumoral radiological density
• Safety profile in this patient population
• Exploratory, hypothesis-generating pharmacogenomic analyses to correlate
molecular parameters in patient samples with clinical outcomes (objective
response and PFS) within and across patient strata.
|
Primary end point(s): Confirmed objective tumor response (CR or PR) rate (RECIST) in each group.
Each patient will be assigned one of the following categories:
Complete response (CR)
Partial response (PR)
Stable disease (SD)
Progressive disease (PD)
Reasons for non-evaluability will be subdivided into the following categories:
1) ‘early toxicity’ (as reason for withdrawal without on-/end-oftreatment
tumor assessment available)
2) ‘never treated’ (no on-/end-of-treatment tumor assessment available)
3) ‘other’ (e.g., no baseline tumor assessment, technical
reasons, absence of on-/end-of-treatment tumor assessment for other reasons than ‘death’, ‘early toxicity’ or ‘never treated’, consent withdrawal before evaluation,)
To be assigned a status of PR or CR, changes in tumor measurements must be
confirmed by repeated assessments that should be performed no less than 4 weeks after the criteria for response are first met.
|
|
Secondary ID(s)
|
|
ET-B-027-06
|
|
Source(s) of Monetary Support
|
|
Ethics review
|
Status: Approved
Approval date: 01/08/2007
Contact:
|
|