Status:

UNKNOWN

QOL of Women With HR-Positive Metastatic BC Treated in the First-line Setting: Comparison Between Public and Private Institutions.

Lead Sponsor:

Beneficência Portuguesa de São Paulo

Conditions:

Quality of Life

Breast Neoplasm Female

Eligibility:

FEMALE

18+ years

Brief Summary

Assess the quality of life in patients with hormone receptor positive, human epidermal growth factor receptor-type 2 negative metastatic breast cancer treated in first line (patients with new metastas...

Detailed Description

The main objective of the study is to assess the quality of life using the EORTC-QLQ-C30 (EORTC Quality of Life Questionnaire) and the EORTC-QLQ-BR23 (EORTC Quality of Life Questionnaire - Breast Canc...

Eligibility Criteria

Inclusion

  • Patients who agree to participate by signing a document of free and informed consent (ICF), indicating that the research participant was informed about all relevant aspects of the study;
  • Female patients ≥ 18 years of age;
  • Patients diagnosed with hormone receptor positive, human epidermal growth factor receptor-type 2 -negative metastatic breast cancer; in first-line treatment (metastatic de novo disease or patients with recurrence during adjuvant endocrine therapy).
  • First-line treatment can be considered as cytotoxic chemotherapy, isolated endocrine therapy or endocrine therapy in combination with 4/6 cyclin inhibitors.
  • Patients on treatment for at least three (3) months and no more than eighteen (18) months.
  • Have performance status Eastern Cooperative Oncology Group (ECOG scale) of 0-2.
  • Do not present other concomitant neoplasms.

Exclusion

  • Patients who refuse to participate.
  • Illiterate patients, with low levels of education or cognitive deficits that make it difficult to answer the questions of the data collection instrument.
  • Patients with life expectancy \<3 months.
  • Treatment with any product under investigation during the last 28 days.

Key Trial Info

Start Date :

July 14 2021

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

July 30 2022

Estimated Enrollment :

202 Patients enrolled

Trial Details

Trial ID

NCT05287139

Start Date

July 14 2021

End Date

July 30 2022

Last Update

March 18 2022

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hospital Pérola Byington

São Paulo, Brazil