1E10 anti-idiotype vaccine, metastatic breast cancer, phase II

Phase 2

• Conditions: Breast carcinoma in stage IV or progressive metastatic disease; Breast Neoplasms; Carcinoma; Breast Diseases

• Registration Number: RPCEC00000008
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-27
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

1)Female patients with cyto- ’histological confirmed diagnostic of recurrent or Stage IV metastatic breast cancer 2)Patients that have received the oncospecific therapy according to the treatment guidelines established in the country and that have ended the different protocols in a time period of 4 weeks prior to entry in the trial. 3)Patient’s informed consent to participate in the investigation obtained. 4)Age = 18 years. 5)Patients with life expectancy = 6 months. 6)Performance Status according to WHO from 0 to 2. 7)Clinical laboratory parameters: a.-) Hematopoietic parameters: - Hb>100g/l, - Leucocytes>4 x 109cells/l - Granulocytes>2x109 cells/l, - Platelets> 100 x 109cells/ l. b.-) Liver (not exceeding the normal upper limit by three times), bilirubin: 17mol/l (LSN), ALAT: 40U/l (LSN), ASAT: 40U/l (LSN), alkaline phosphatase: 279U/l c.-) Kidney: serum creatinine: 132 mmol/l.

Exclusion Criteria

1.Patients with breast cancer in stage Iv or recurrent diseases that have received oncospecific therapy and have concluded the different protocols in a time period inferior to 4 weeks or greater than 4 weeks prior to entry in the trial. 2.Pregnant or breastfeeding patients. 3.Patients with prior history of demielinizing disease or inflammatory disease of the CNS or the peripheral nervous system. 4.Patients with previous malignancies except carcinoma in situ of cervix or skin cancer (not melanoma), treated properly. 5.Patients with acute or chronic infectious diseases. 6.Patients with acute allergic status or history of severe allergic reactions. 7.Patients with autoimmune diseases or chronic non-compensated diseases. 8.Patients who present the contralateral breast as the only site of metastatic disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time and time to progression. Measuring Time: 18 and 24 months.

Secondary Outcome Measures

Name	Time	Method
Humoral Immune Response, toxicity and clinical response. Measuring time: 18 and 24 months