Status:
COMPLETED
Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy
Lead Sponsor:
Columbia University
Conditions:
Locally Advanced Malignant Neoplasm
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 standar...
Detailed 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 re...
Eligibility Criteria
Inclusion
- English or Spanish speaking women age ≥18
- Heart Rate \> 60 bpm
- Systolic Blood Pressure \> 100 mm/Hg
- Deemed eligible to receive neoadjuvant chemotherapy with 12 cycles of weekly taxane therapy (paclitaxel 80mg/m2 or Abraxane 100 mg/m2 if there is a shortage of paclitaxel) followed by 4 cycles of Adriamycin (60mg/m2) and cyclophosphamide (600 mg/m2) given every 2 weeks with growth-factor support.
- Echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) with ejection fraction \> 50%.
- Patients with hormone receptor +/- and human epidermal growth factor receptor 2 protein (HER2) +/- breast cancer are eligible
- If a patient has HER2-positive breast cancer, Herceptin and Perjeta will be given along with taxane therapy
- Any stage invasive breast cancer provided the primary breast tumor size is ≥ 1 cm
- Agree to participate in research blood collection at 4 different time periods (20 ml = 4 teaspoons)
- Agree to the evaluation of already collected core biopsy, as well as surgical resection tissue, for predictive biomarkers. The biopsy prior to Taxol #1 is optional.
Exclusion
- Patients failing to meet the inclusion criteria
- Corrected QT interval (QTc) prolongation as defined by \> 470 milliseconds on electrocardiogram (ECG)
- First-degree Atrioventricular (AV) block on ECG in which P-R interval lengthened \> 200 milliseconds; Second Degree; or Third Degree
- On beta-blocker treatment. If discontinued, patients must have been off beta-blockers for at least 3 months.
- History of asthma, given concern for β-blockade in this population
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 16 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01847001
Start Date
October 1 2012
End Date
October 16 2019
Last Update
September 10 2021
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032