ASER ASSISTED IMMUNOTHERAPY

Not Applicable

• Conditions: C50; -C50 Malignant neoplasm of breast; Malignant neoplasm of breast

• Registration Number: PER-091-09
• Lead Sponsor: IMMUNOPHOTONICS / THE SOURCE SAC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-09-25
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

• Be over 20 years old and under 80.
• Have clinical cycles of recurrent breast cancer
• Have no other therapeutic options at hand.
• Be considered able to return for all study visits for one year

Exclusion Criteria

• Have another systemic disease that compromises the tumor being studied.
• Be receiving or having received in a period of 4 weeks before the start of the study treatment any new drug under investigation: cytokine or systemic steroid therapy.
• Be allergic to shellfish
• Have cardiovascular disease of class III or IV according to the functional criteria of the association of cardiac studies in New York.
• Currently, have samples of the history of liver disease, kidney disease, allergic rheumatology (i.e. anaphylactic reaction) or CMS (including seizures)
• Have Diabetes Melitus.
• Have signs or history of clinical depression or suicidal tendencies.
• Have autoimmune thyroid disease or Systemic Lupus Erythematosus
• Having skin of type 5 or 6 in the area to be treated (laser light cannot penetrate skin that is very dark enough).
• Have a tattoo that covers the area to be treated (the laser light cannot penetrate the tattoos well enough).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:based on the physical and radiographic measurement of the tumor at the end of 52 weeks of treatment or earlier if treatment is discontinued prematurely.<br>Measure:Response rate<br>Timepoints:52 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Measurement of hematology laboratory test values during the study<br>Measure:Variation in the values of hematology studies<br>Timepoints:after 2, 6, 12, 24 and 36 weeks of treatment<br>