Discovering Factors in Metastatic Breast Cancer Patients' Clinical Trial Experiences

NCT ID: NCT05760183

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2026-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

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Michael B Gill

Role: CONTACT

415-900-4227

References

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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.

Reference Type BACKGROUND
PMID: 24892723 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27364503 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27396647 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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82944089

Identifier Type: -

Identifier Source: org_study_id

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