Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01847001 |
Other study ID # |
AAAI9158 |
Secondary ID |
UL1TR000040 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
October 2012 |
Est. completion date |
October 16, 2019 |
Study information
Verified date |
August 2021 |
Source |
Columbia University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This study is being conducted in patients with newly diagnosed breast cancer that will be
undergoing chemotherapy prior to surgery - neoadjuvant chemotherapy. The study involves
treatment with standard chemotherapy and a commonly used, FDA-approved, blood pressure drug
called propranolol (Inderal). The purposes of this study are to:
1. Determine the effect of propranolol plus chemotherapy on breast cancer cells as well as
the growth of blood vessels surrounding breast cancer cells.
2. Determine the side effect profile of propranolol and chemotherapy in patients with
breast cancer receiving neoadjuvant chemotherapy.
This research is being done because previous laboratory work has shown that propranolol may
decrease the ability for the blood vessels around breast cancer cells to grow, which may be
important in helping cancer cells grow. It also may reduce the likelihood for breast cancer
cells to spread. If changes are seen in the breast cancer cells and surrounding blood vessels
in this study, we will pan to evaluate whether propranolol decreases the likelihood of breast
cancer from recurring in future, later studies. All chemotherapy regimens used in this study
have been the standard of care for many years; however, the use of propranolol is being
researched along with the chemotherapy regimens.
Description:
While a number of therapeutic options exist for patients with breast cancer (BC), breast
tumor biology is differs across tumors and not all BCs respond to treatment. Identifying a
marker predicting response could spare non-responders unnecessary side effects, cost, and
time. A recent example in BC is bevacizumab, an expensive anti-angiogenic monoclonal
antibody, for which the FDA revoked approval for patients with metastatic BC. While this
targeted therapy may benefit some patients, no appropriate predictive marker has been
identified in the drug development process. An ideal biologic marker would be easy to
perform, reliable, low-cost and non-invasive. A limitation of assessing tumor-based markers
in metastatic BC is the inability to procure tumor tissue at different treatment times. To
circumvent this issue, anti-cancer agents can be assessed pre-operatively, where women with
newly diagnosed BC receive a study drug, alone or with chemotherapy, between diagnostic
breast biopsy and surgical resection. In addition, tumor changes can be directly compared to
modulation of non-invasive markers, such as functional radiographs or blood, to identify a
non-invasive marker predicting tumor response.
The investigators are conducting a neoadjuvant single-institution trial with the
non-selective, inexpensive β -blocker propranolol with chemotherapy in locally advanced BC.
β-blockade regulates angiogenesis in primary breast tumors. In these trials, the
investigators plan to evaluate treatment-related microvascular response via changes in breast
Diffuse Optical Tomography (DOT), a non-invasive, fast, safe, and inexpensive breast imaging
tool. As the optical property contrast from endogenous chromophores (oxyhemoglobin,
deoxyhemoglobin, water, and lipid) provides information on tissue vascularity, it can monitor
response to anti-angiogenic agents. DOT changes occur as early as 1 week after starting
pre-operative therapy. The dynamic DOT system incorporated in these trials is unique to
Columbia University Medical Center (CUMC), as it has been designed by Columbia biomedical
engineers. CUMC's laboratory collaborators have measured this DOT system with
anti-angiogenesis agents in animal models, demonstrating the translational nature of this
project. While non-dynamic DOT has been assessed in other neoadjuvant trials with small
cohorts receiving heterogeneous chemotherapy agents, none have evaluated DOT response to
anti-angiogenic agents.