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Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials

Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials - Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials (SELECT BC ECO)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000020645
Enrollment
68
Registered
2016-01-20
Start date
2009-08-26
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

None listed

Sponsors

SELECT BC executive committee
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: This study was carried out as a concomitant study of a randomized controlled study in metastatic or recurrent breast cancer patients SELECT BC, to all patients who received the participation description of the present study after the start SELECT BC interest. The definition of the nonparticipation patients are those who satisfied with the csse selection criteria of the SELECT BC, though expressed refusal to participate in SELECT BC. (i) Women with a histologically confirmed diagnosis of breast cancer. (ii) One of the following conditions has to be met for a diagnosis of metastatic breast cancer: 1) At presentation, the patient has distant metastasis. 2) The patient has breast cancer that has worsened or recurred in association with distant metastasis after treatment (after surgery and preoperative and postoperative treatment); however, local recurrence is excluded.

Exclusion criteria

Exclusion criteria: (i) Women who are pregnant, nursing infants or intend to become pregnant. (ii) Overexpression of HER2 (Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive.

Design outcomes

Primary

MeasureTime frame
Others

Secondary

MeasureTime frame
Overall Survival

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Reserchi Foundation Comprehensive Support Project for Clinical Research

cspor-office@csp.or.jp03-5287-2633

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026