Phase II, multicenter, open-label, clinical trial of Trabectedin (Yondelis®) inMetastatic Breast Cancer Patients with triple negative profile (ER-, PR-, HER2-),HER2 overexpressing tumors and BRCA1 or BRCA2 mutation carriers

Phase 1

• Conditions: Progressive metastatic breast cancer previously treated in the following subpopulation of patients:Group A: Triple negative phenotype: Estrogen Receptor, Progesterone Receptor andHER-2 negative status (surrogate of basal-like type)Group B: HER-2 overexpressing tumors.Group C: Familial BRCA1 or BRCA2 mutation carriers; MedDRA version: 9.1Level: PTClassification code 10055113Term: Breast cancer metastatic

• Registration Number: EUCTR2007-000794-31-FR
• Lead Sponsor: Pharma Mar, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-06-07
• Study Completion: 2011-08-11
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 321

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified