NCT01847001

A Study of the Beta-blocker Propranolol Alone and With Chemotherapy in Patients Receiving Neoadjuvant Treatment for Newly Diagnosed Breast Cancer

Completed Phase 2 Results posted Last updated 19 August 2021

What this trial tests

Phase 2 trial testing Propranolol in Locally Advanced Malignant Neoplasm in 10 participants. Completed in 16 October 2019.

Timeline

1 October 2012

Primary endpoint
31 December 2018

16 October 2019

Quick facts

Lead sponsor	Columbia University
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	10
Start date	1 October 2012
Primary completion	31 December 2018
Estimated completion	16 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Propranolol
• DOT imaging
• Paclitaxel — full drug profile →
• Nab-paclitaxel
• Trastuzumab (trastuzumab) — full drug profile →
• Pertuzumab (pertuzumab) — full drug profile →
• Doxorubicin
• Cyclophosphamide (cyclophosphamide) — full drug profile →
• Surgery
• Premedication
• Anti-nausea therapy
• Pegfilgrastim

Conditions studied

• Locally Advanced Malignant Neoplasm — all drugs for Locally Advanced Malignant Neoplasm →
• Breast Cancer — all drugs for Breast Cancer →

Sponsor

Columbia University

Who can join

18 and older, female only, with Locally Advanced Malignant Neoplasm or Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Mean Adherence to Propranolol
  Time frame: Approximately 6 months
  Propranolol adherence was documented biweekly by pill counts and drug diary checks.
• Total Number of Participants Who Reached The Target Propranolol Dosing
  Time frame: Approximately 6 months
  The target Propranolol dosing was 80mg ER daily.

Sponsor's own 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. 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The updated landscape of tumor microenvironment and drug repurposing.
   Jin MZ, Jin WL. · · 2020 · cited 900× · PMID 32843638 · DOI 10.1038/s41392-020-00280-x
2. Drug repurposing for cancer therapy.
   Xia Y, Sun M, Huang H, Jin WL. · · 2024 · cited 229× · PMID 38637540 · DOI 10.1038/s41392-024-01808-1
3. Therapeutic avenues for cancer neuroscience: translational frontiers and clinical opportunities.
   Shi DD, Guo JA, Hoffman HI, Su J, et al · · 2022 · cited 104× · PMID 35114133 · DOI 10.1016/s1470-2045(21)00596-9
4. Nerves in the Tumor Microenvironment: Origin and Effects.
   Wang W, Li L, Chen N, Niu C, et al · · 2020 · cited 76× · PMID 33392191 · DOI 10.3389/fcell.2020.601738
5. Stress hormones reduce the efficacy of paclitaxel in triple negative breast cancer through induction of DNA damage.
   Reeder A, Attar M, Nazario L, Bathula C, et al · · 2015 · cited 76× · PMID 25880007 · DOI 10.1038/bjc.2015.133
6. Breast cancer and social environment: getting by with a little help from our friends.
   Hinzey A, Gaudier-Diaz MM, Lustberg MB, DeVries AC. · · 2016 · cited 73× · PMID 27225892 · DOI 10.1186/s13058-016-0700-x
7. Repurposing Drugs in Oncology (ReDO)-Propranolol as an anti-cancer agent.
   Pantziarka P, Bouche G, Sukhatme V, Meheus L, et al · · 2016 · cited 65× · PMID 27899953 · DOI 10.3332/ecancer.2016.680
8. β-Adrenergic Receptor Signaling in Prostate Cancer.
   Braadland PR, Ramberg H, Grytli HH, Taskén KA. · · 2014 · cited 61× · PMID 25629002 · DOI 10.3389/fonc.2014.00375