Clinical trial · Interventional
Neoadjuvant Propanolol in Breast Cancer
Pilot "Window of Opportunity" Neoadjuvant Study of Propranolol in Breast Cancer
NCT02596867CI-TRIAL-00031882NPBCterminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): poor accrual
Summary
Brief summary (as posted)
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 .
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| propanolol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- open label single arm, drug propanolol
- description
- all subjects will receive the experimental drug
- interventionNames
- Drug: propanolol
Primary outcomes (1)
- measure
- Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
- timeFrame
- 3 weeks
- description
- 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
Secondary outcomes (1)
- measure
- Assess the Safety, Toxicity and Adherence to Propranolol.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Ages 18- 65 * diagnosis of stage I-III breast cancer , confirmed by a core biopsy * Planning to undergo definitive surgery including mastectomy or breast conserving surgery * Systolic blood pressure must be \>100 mmHg but no more than 140 mmHg and/or diastolic \> 60 mmHg and no more than 95 mmHg. * normal baseline EKG Exclusion criteria: * Pregnancy; potential subjects of female bearing age will have to complete a pregnancy test during screening to ensure that they are not pregnant. Potential patients who are post-menopausal must have confirmed one year without menstrual cycle. * Free of major medical illnesses including: * Uncontrolled Diabetes (HbA1c of ≤ 8 if previously tested) * Uncontrolled hypertension: BP \>systolic 140/ diastolic \> 95 * Cardiac diseases (history of cardiac valve disease, coronary artery disease, congestive heart failure, A-V block, peripheral vascular disease, any cardiac arrhythmia/bradycardia) with the exception of the diagnosed cancer. * Histories of asthma, bronchospastic disease, or obstructive pulmonary disease * Previously diagnosed thyrotoxicosis * Severe allergic reactions to medications which are included in the beta blocker family * Previously or currently treated with a beta adrenergic receptor antagonist * Patients with locally advanced or inflammatory breast cancer not amenable to surgical resection * Patients taking any of the following medications will be excluded: * Drugs that are categorized as digitalis glycosides, beta-blockers and calcium channel blockers, ACE inhibitors and alpha blockers * Amiodarone * Cimetidine * Ciprofloxacin * Delavudin * Dobutamine * Ethanol * Fluconazole * Fluoxetine * Fluvoxamine * Haloperidol * Imipramine * Isoniazid * Isoproterenol * Luvoxamine * Paroxetine * Phenytoin * Phenobarbital. * Propafenone. * Quinidine * Reserpine * Rifampin * Ritonavir * Rizatriptan. * Tenioposide * Theophylline * Thyroxine * Tolbutamide. * Warfarin * Zileuton * Zolmitriptan
References
Publications (0)
Data not yet available
No reference posted for this study.