A Phase 2 interventional study of propanolol in Breast Cancer, sponsored by Texas Tech University Health Sciences Center, El Paso. Terminated at 1 site in United States. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-03-01.
Sponsored by Texas Tech University Health Sciences Center, El Paso · Phase 2, Interventional, and Treatment
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 .
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 2 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Texas Tech University Health Sciences Center, El Paso is the lead sponsor of 43 studies on the registry; 3 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 2 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Patients taking any of the following medications will be excluded:
all subjects will receive the experimental drug
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
Evaluate the Effect of the Beta Blocker Propranolol on Reducing the Tumor Proliferative Index Using Ki-67.
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
Time frame: 3 weeks
Assess the Safety, Toxicity and Adherence to Propranolol.
Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)
Time frame: 3 weeks
Prospective - two breast cancer patients enrolled over 6 months perios from clinic .
| Milestone | Open Label Single Arm, Drug Propanolol |
|---|---|
| Started | 2 |
| 2 patients prospectively recruited | 2 |
| Completed | 2 |
| Not completed | 0 |
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
| % mean difference of Ki67 | Open Label Single Arm, Drug Propanolol |
|---|---|
| Stage I Patient 1 | 23 |
| Stage III Patient 2 | 66 |
Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.(Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4)
| Participants | Open Label Single Arm, Drug Propanolol |
|---|---|
| Assess the Safety, Toxicity and Adherence to Propranolol. | 0 |
Collected over AEs were monitored during and at the end of treatment (a total of 3 weeks). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label Single Arm, Drug Propanolol | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Age, Categorical(Participants) | Open Label Single Arm, Drug Propanolol |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Open Label Single Arm, Drug Propanolol |
|---|---|
| Female | 2 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | Open Label Single Arm, Drug Propanolol |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Open Label Single Arm, Drug Propanolol |
|---|---|
| United States | 2 |
| Tumor response by Ki 67(Participants) | Open Label Single Arm, Drug Propanolol |
|---|---|
| Count of participants | 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — if the study is completed, yes
This study is terminated, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Texas Tech University Health Sciences Center, El Paso