Metastatic Breast Cancer Clinical Trial
Official title:
An Observational Medical Trial Assessing Patterns in Experiences of Participants of Metastatic Breast Cancer Clinical Trials
| NCT number | NCT05760183 |
| Other study ID # | 82944089 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | March 2024 |
| Est. completion date | March 2026 |
Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This trial will evaluate the safety and efficacy of metastatic breast cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future metastatic breast cancer studies.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | March 2026 |
| Est. primary completion date | March 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient is at least 18 years of age - Patient is able and willing to comply with the treatment/follow-up schedule and requirements - Patient must provide written informed consent Exclusion Criteria: - Women who are pregnant, intend to become pregnant, or are lactating - Inability to perform regular electronic reporting - Participants who are vulnerable to any intervention |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
Conde-Estevez D, Tusquets I, Servitja S, Martinez-Garcia M, Salas E, Albanell J. An overview of randomized clinical trials in metastatic breast cancer: variables affecting regulatory drug approval. Anticancer Drugs. 2014 Oct;25(9):992-7. doi: 10.1097/CAD.0000000000000130. — View Citation
Ghislain I, Zikos E, Coens C, Quinten C, Balta V, Tryfonidis K, Piccart M, Zardavas D, Nagele E, Bjelic-Radisic V, Cardoso F, Sprangers MAG, Velikova G, Bottomley A; European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group; Breast Cancer Group; EORTC Headquarters. Health-related quality of life in locally advanced and metastatic breast cancer: methodological and clinical issues in randomised controlled trials. Lancet Oncol. 2016 Jul;17(7):e294-e304. doi: 10.1016/S1470-2045(16)30099-7. — View Citation
Kuerer HM, van la Parra RF. Breast Cancer Clinical Trials: Past Half Century Moving Forward Advancing Patient Outcomes. Ann Surg Oncol. 2016 Oct;23(10):3145-52. doi: 10.1245/s10434-016-5326-9. Epub 2016 Jun 30. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of patients who decide to enroll in a metastatic breast cancer clinical study. | 3 months | ||
| Primary | Number of metastatic breast cancer study participants who remain in clinical trial until completion. | 12 months |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
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