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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05769491
Other study ID # 84434789
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date April 2026

Study information

Verified date March 2023
Source Power Life Sciences Inc.
Contact Michael B Gill
Phone 4159004227
Email bask@withpower.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Clinical trials can sometimes favor certain demographic groups. Additionally, there is limited research that delves into the factors that influence participation in clinical trials, both positive and negative. The goal is to identify the obstacles and challenges that prevent participation in Triple Negative Breast Cancer clinical trials, as well as the reasons for withdrawal or discontinuation. The insights gained from this study will ultimately benefit those with Triple Negative Breast Cancer who may be invited to participate in clinical research in the years to come.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date April 2026
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age = 18 years - Willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. - Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol Exclusion Criteria: - Pregnant or lactating woman - Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial - Inability to perform regular electronic reporting

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Power Life Sciences Inc.

References & Publications (3)

Costa REARD, Oliveira FTR, Araujo ALN, Vieira SC. Prognostic factors in triple-negative breast cancer: a retrospective cohort. Rev Assoc Med Bras (1992). 2021 Jul;67(7):950-957. doi: 10.1590/1806-9282.20210249. — View Citation

Shao Z, Chaudhri S, Guo M, Zhang L, Rea D. Neoadjuvant Chemotherapy in Triple Negative Breast Cancer: An Observational Study. Oncol Res. 2016;23(6):291-302. doi: 10.3727/096504016X14562725373879. — View Citation

Wu B, Sun C, Sun X, Li X. The effect of chemotherapy on survival in oldest old patients with nonmetastatic triple negative breast cancer: A populationbased observational study. J Clin Pharm Ther. 2022 Nov;47(11):1826-1836. doi: 10.1111/jcpt.13776. Epub 2022 Sep 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of triple negative breast cancer patients who decide to enroll in a clinical study 3 months
Primary Rate of triple negative breast cancer patients who remain in a clinical study to completion 12 months
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