Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials 2

Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials 2 - Prospective Cohort Study: Whether or Not Patients Benefit From Participation Itself in Randomized-controlled Trials2 (SELECT BC ECO 2)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021099

Enrollment

Registered

2016-02-19

Start date

2011-06-27

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

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-CONFIRM, to all patients who received the participation description of the present study after the start SELECT BC-CONFIRM interest. The definition of the nonparticipation patients are those who satisfied with the csse selection criteria of the SELECT BC-CONFIRM, though expressed refusal to participate in SELECT BC -CONFIRM. (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) Is an exacerbation or recurrent breast cancer in distant metastasis after treatment. However, local Recurrence is excluded.

Exclusion criteria

Exclusion criteria: (i) Overexpression of HER2(Her2/neu, Erb B2), or the results of fluorescence in situ hybridization are positive. (ii) A past history of hypersensitivity to the protocoltreatment drugs or their solvents. (iii) The presence of other active cancers

Design outcomes

Primary

Measure	Time frame
Overall Survival	—

Countries

Japan

Contacts

Public ContactAkira Yamao

Public Health Research Foundation Comprehensive Support Project for Clinical Research

cspor-office@csp.or.jp03-5287-2636

Outcome results