Dendritic Cell Based Therapy for Breast Cancer Patients

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

The primary aim of this study is to investigate time to progression in breast cancer patients vaccinated with autologous dendritic cells pulsed with peptides in combination with adjuvant aromatase inhibitor (AI), Thymosin 1 alpha and interleukin-2. The secondary aim is to investigate whether a measurable immune response can be induced, and to evaluate the clinical effect (objective response rate) of the vaccination regime.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inge Marie Svane
• Treatments: Anastrozole; Aromatase Inhibitors; Exemestane; Interleukin-2; Lactitol; Letrozole; Thymalfasin; Vaccines

Criteria

Inclusion Criteria:

• Patients with histological proven metastatic or locally advanced ER+/PGR+ breast cancer in progression after receiving 1. line endocrine therapy.

• Further inclusion criteria: p53+ tumour, PS≤1, postmenopausal. Age >18, PS ≤ 1 and acceptable CBC and blood chemistry results

Exclusion Criteria:

• Patients with a history of any other neoplastic disease less than 5 years ago (excepting treated carcinoma in situ of the cervix and basal/squamous carcinoma of the skin)

• Patients with metastatic disease in the central nervous system

• Patients with other significant illness including severe allergy, asthma, DM, angina pectoris or congestive heart failure

• Patients with acute or chronic infection including HIV, hepatitis og TB

• Patients who received antineoplastic therapy including chemotherapy, radiation, immunotherapy or other agents, less than 4 weeks before the beginning of the trial

• Patients who received corticosteroids or other immunosuppressive agents

• Patients with active autoimmune diseases such as lupus erythematosus, rheumatoid arthritis or thyroiditis

• Severe hypercalcemia