A Phase II trial evaluating the immunological and clinical efficay and safety of HER-2 Protein Autovac(TM) monotherapy in patients with metastatic breast cancer - NA

Pharmexa A/S0 sites60 target enrollmentJuly 13, 2004

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Female patients with histologically proven metastatic or locally advanced breast cancer who have HER-2 overexpression in the primary tumour and/or a metastatic lesion.
Sponsor: Pharmexa A/S
Enrollment: 60
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

July 13, 2004

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•Female breast cancer patients who fulfil the following criteria will be eligible for inclusion in the trial:
•1\.Histological proven adenocarcinoma of the breast.
•2\.Locally advanced or metastatic disease.
•3\.Centrally confirmed HER\-2 overexpression by either a score 3\+ by DAKO HercepTest(TM) (DakoCytomation) or a positive DAKO HER2 FISH pharmDx(TM) (DakoCytomation) test result on either the primary tumour or metastasis. The HER\-2 expression status of the patient MUST BE confirmed by the central laboratory before enrolment and the patient’s first vaccination with HER\-2 Protein AutoVac(TM).
•4\.At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST).
•5\.Age less than or equal to 18 yearsand less than or equal to 80 years
•6\.Life expectancy more than or equal to 6 months.
•7\.Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1\.
•8\.Signed written informed consent prior to trial entry.
•9\.Willing and able to comply with the protocol for the duration of the trial.

•Patients will be excluded from the trial should they meet one or more of the following criteria:
•1\.Women of child\-bearing potential not using a reliable and appropriate contraceptive method. Pregnant and lactating women. Women of childbearing potential with either a positive or no pregnancy test at screening.
•2\.Patients who have received chemotherapy or other immunosuppressive therapy within 4 weeks prior to start of study treatment.
•3\.Patients who have received hormonal therapy within 4 weeks of starting study treatment.
•4\.Radiotherapy involving more than 25% of the bone marrow given within 3 months before inclusion in the study.
•5\.Patients who have previously been treated at any time with any HER\-2 based anticancer vaccine.
•6\.Patients who have been treated with any other anticancer vaccine within 1 year of starting study treatment.
•7\.Patients who have previously been treated with Herceptin® (trastuzumab) or any other agents, commercially available or investigational, that target the HER\-2 axis.
•8\.Concurrent immunosuppressive therapy, including, but not limited to, low dose methotrexate or cyclophosphamide, corticosteroids (with the exception of topically applied/inhaled steroids). Concurrent anti\-tumour treatment.
•9\.Other cancers than breast cancer, except for basal cell carcinoma of the skin and in situ carcinoma of cervix.