A Phase II trial evaluating the immunological and clinical efficacy and safety of HER-2 Protein AutoVac(TM) and Stimulon® Adjuvant QS-21 monotherapy in patients with metastatic breast cancer

• 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.

• Registration Number: EUCTR2005-000558-60-HU
• Lead Sponsor: Pharmexa A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 60

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

•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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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:<br>•A complete response (CR) or partial response (PR), or<br>•Stable disease (SD) for at least 6 months (26 weeks).<br>;Secondary Objective: •To obtain data on the immune response following long-term treatment.<br>•To obtain safety data on long-term use.<br>;Primary end point(s): The primary endpoint of the trial is clinical benefit rate, defined as<br>•Complte Response or Partial Response, or<br>•Stable Disease for at least 6 months (26 weeks) (RECIST criteria).