Study of Propranolol in Newly Diagnosed Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy

Description

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. The use of propranolol is experimental in this study.

Study Start Date

October 2012

Estimated Completion Date

October 2016

Interventions

  • Procedure: Surgery
  • Drug: Paclitaxel
  • Drug: Premedication
  • Drug: Propranolol
  • Drug: Pertuzumab
  • Drug: Doxorubicin
  • Other: DOT imaging
  • Drug: Nab-paclitaxel
  • Drug: Trastuzumab
  • Drug: Anti-nausea therapy
  • Other: Breast imaging - Diffuse Optical Tomography (DOT)
  • Drug: Cyclophosphamide
  • Drug: Pegfilgrastim

Specialties

  • Oncology: Breast,Diagnostics/Radiology,Pharmacology/Therapy

MeSH Terms

  • Breast Neoplasms
  • Breast imaging
  • Propranolol

Study ID

Columbia University -- AAAI9158

Status

Unknown

Trial ID

NCT01847001

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

20

Sponsor

Columbia University

Inclusion Criteria

  • English or Spanish speaking women age ?18
  • Bra cup no larger than DD, given that DOT cannot measure breast size larger than DD
  • 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 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 Criteria

  • Patients failing to meet the inclusion criteria
  • Corrected QT interval (QTc) prolongation as defined by > 470 milliseconds on electrocardiogram (ECG)
  • First degree AV block on ECG in which PR 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 ?-blockade in this population

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Columbia University Medical Center - New York, New York 44.8 miles Julia Forman 212-305-5528 jf2683@columbia.edu

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