Breast Cancer Clinical Trial
Official title:
Investigation of Patterns in Clinical Trial Experiences by Patients Participating in Triple Negative Breast Cancer Clinical Trials
| 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 |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
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
| 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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