Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

All Drugs and Chemicals

Propranolol

Adrenergic Agents

Adrenergic beta-Antagonists

Adrenergic Antagonists

Neurotransmitter Agents

all subjects will receive the experimental drug

Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

propanolol

Zeina Nahleh, MD

This trial is a Phase II study using the "window-of-opportunity" design in which the treatment-free window between breast cancer diagnosis and surgical tumor resection is used to study the biological effects of the beta blocker propranolol .

* Patients will be recruited from the Garbar Breast Care Center and University Medical Center following diagnosis of invasive breast cancer by breast biopsy.
* The sympatholytic nonselective beta blocker propranolol will be administered to all participants in a non-randomized manner at an equal dose of 1.5 mg/kg/day.
* Following surgical resection of the tumor , the primary endpoint of this study is quantified by comparing the proliferative index of the tumor before propranolol administration (quantified using the initial tumor biopsy) and after 3 weeks of propranolol (quantified using the surgically resected tumor).
* Additional molecular analyses and evaluation of safety and toxicity will also be performed to better understand the effects of this treatment on breast cancers and patient adherence to the drug.

Neoadjuvant Propanolol in Breast Cancer

Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer

to evaluate effect of beta adrenergic blockades on breast cancer at by Ki67 percentage change- we are looking at at least 10% mean change in the tumor proliferative index following propranolol treatment

Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)

Texas Tech University Health Sciences Center, El Paso

Professor

Zero AEs were reported/observed during and at the end of treatment. Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4

all subjects will receive the experimental drug

propanolol: Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

Open Label Single Arm, Drug Propanolol

2 subjects enrolled and received the experimental drug

propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

Age, Categorical

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Tumor response by Ki 67

slow accrual was noted , mostly due to scheduling of surgery

Zeina Nahleh

Stage I Patient 1

Stage III Patient 2

We tested the efficacy of propranolol on two patients with breast cancer by recording % reduction of Ki67

Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer.

Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.

2 subjects enrolled and received the experimental drug

propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

Both patients reported no AEs due to treatment during treatment phase

Two patients with breast cancer are included in this analysis. One patient was a stage I breast cancer and the second patient was a stage III breast cancer, AEs were assessed during and after treatment

Assess the Safety, Toxicity and Adherence to Propranolol.

2 subjects enrolled and received the experimental drug propanolol: Participants took 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Neoadjuvant Propanolol in Breast Cancer	NCT02596867	Breast Cancer	propanolol	18 Years - 65 Years	Texas Tech University Health Sciences Center, El Paso
Neoadjuvant Propanolol in Breast Cancer	NCT02596867	Breast Cancer	propanolol	18 Years - 65 Years	Texas Tech University Health Sciences Center, El Paso

Spots Global Cancer Trial Database for b adrenergic pathway