Neoadjuvant/Adjuvant Chemotherapy, Vaccine & Adjuvant Radiation Therapy in p53-Overexpressing Stage III Breast Cancer
Completed · Phase 1/Phase 2
Conditions studied: Breast Cancer
In brief
RATIONALE: Vaccines may make the body build an immune response to kill tumor cells. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving vaccine therapy before and/or after chemotherapy and radiation therapy may cause a stronger immune response. PURPOSE: This randomized phase I/II trial is studying the side effects of two regimens of vaccine therapy and to see how well they work in treating women who are receiving neoadjuvant or adjuvant chemotherapy and adjuvant radiation therapy for stage III breast cancer that overexpresses p53.
Key facts
- Study ID
- NCT00082641
- Run by
- University of Nebraska
- People needed
- 24
- Starts
- 2004-01-01
- Expected to finish
- 2018-01-01
- Last updated by the study team
- 2023-09-22
Who can join
Age: 19 and older, up to 120. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed invasive breast cancer meeting the following criteria:
- Clinically locally advanced disease (stage III) with a primary tumor at least 4 cm by mammogram, ultrasound, or palpation AND/OR palpable axillary nodes larger than 1 cm
- Planned neoadjuvant chemotherapy
- p53-overexpressing tumor by immunohistochemistry
- Delayed-type hypersensitivity to at least 1 of 3 standard antigens
- Female
- ECOG 0-1
- WBC > 4,000/mm\^3
- Platelet count > 100,000/mm\^3
- Bilirubin < 2 times upper limit of normal (ULN)
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
- Creatinine < 2 times ULNHIV negative
- Fertile patients must use effective contraception during and for at least 6 months after study participation
You may not qualify if…
- No prior or concurrent autoimmune disorder
- Not pregnant or nursing/negative pregnancy test
- No other concurrent illness that would preclude study participation
- No prior chemotherapy
- No concurrent participation in another therapeutic clinical trial
Where it is running
- Eppley Cancer Center, University of Nebraska Medical Center — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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