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.
Conditions
Interventions
Product Name: HER-2 Protein AutoVac(TM) and Stimulon(R) Adjuvant QS-21
Product Code: PX104.1.7/QS-21
Pharmaceutical Form: Suspension for injection
Current Sponsor code: 104.1
Concentration unit: mg mi
Sponsors
Pharmexa A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histological proven adenocarcinoma of the breast. • Locally advanced or metastatic disease. • 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. • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumours (RECIST). • Age more than or equal to 18 years and less than or equal to 80 years. • Life expectancy more than or equal to 6 months. • An Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1. • Signed written informed consent prior to trial entry. • Willing and able to comply with the protocol for the duration of the trial. • No more than two prior chemotherapy regimens for locally advanced/metastatic disease (adjuvant chemotherapy after primary therapy is not counted as a regimen). • No more than three prior lines of endocrine treatment for locally advanced/metastatic disease 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
Exclusion criteria: • 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. • Patients who have received chemotherapy or other immunosuppressive therapy within 4 weeks prior to start of study treatment. • Patients who have received hormonal therapy within 4 weeks of starting study treatment. • Radiotherapy involving more than 25% of the bone marrow given within 3 months before inclusion in the study. • Patients who have previously been treated at any time with any HER-2 based anticancer vaccine. • Patients who have been treated with any other anticancer vaccine within 1 year of starting study treatment. • Patients who have previously been treated with Herceptin® (trastuzumab) or any other agents, commercially available or investigational, that target the HER-2 axis. • 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. • Other cancers than breast cancer, except for basal cell carcinoma of the skin and in situ carcinoma of cervix. • Patients with history of significant cardiovascular disease or left ventricular ejection fraction (LVEF) <50%, determined by echocardiogram or multiple gated acquisition (MUGA) scans. • Uncontrolled hypertension. • Participation in another clinical trial with an investigational agent within 30 days preceding initiation of treatment. • Known infection of human immunodeficiency virus (HIV). • History of or co-existing severe auto-immune diseases or other diseases which qualify as auto-immune in origin. • Significantly impaired immune function as judged by the investigator. • Patients with abnormal baseline haematology values, abnormal baseline liver function tests, known renal dysfunction or abnormal serum creatinine values. • A history or clinical evidence of central nervous system (CNS) metastases. • Any other serious medical, social or mental condition which, in the opinion of the investigator, would be detrimental to the patient or the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the trial is to demonstrate evidence of clinical efficacy of HER-2 Protein AutoVac(TM)/QS-21, that is the number of evaluable patients with evidence of clinical benefit, defined as: • A complete response (CR) or partial response (PR), or • Stable disease (SD) for at least 6 months (26 weeks). ;Secondary Objective: • To obtain data on the immune response following long-term treatment. • To obtain safety data on long-term use. ;Primary end point(s): The primary endpoint of the trial is clinical benefit rate, defined as •Complte Response or Partial Response, or •Stable Disease for at least 6 months (26 weeks) (RECIST criteria). | — |
Countries
Hungary
Outcome results
None listed