Clinical trial · Observational
Quality of Life in Metastatic Breast Cancer (MBC) Patients in Second Line Monochemotherapy
Study of Quality of Life in Patients With Metastatic Breast Cancer Treated With Second-line Monochemotherapy
NCT02403869CI-TRIAL-00059399DD-CMMcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Post-authorization, prospective follow-up, multi-centre, national study to estimate definitive deterioration in the quality of life in patients with metastatic breast cancer treated with second-line monochemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Group 1
- description
- MBC patients starting treatment with monochemotherapy for second line of quimiotherapy treatment for metastatic disease
Primary outcomes (1)
- measure
- Definitive deterioration at 6 months
- timeFrame
- 6 months
- description
- Proportion of patients with definitive deterioration at six months after initiation of second-line mono-chemotherapy for MBC
Secondary outcomes (11)
- measure
- Definitive deterioration at 3 months
- timeFrame
- 3 Months
- description
- Description Proportion of patients with definitive deterioration at 3 months after the start of the second-line mono-chemotherapy and at the time of disease progression or completion of treatment for other reasons
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who give their written informed consent. * Patients with metastatic breast cancer who start treatment with second-line monochemotherapy. * Patients of both sexes, at least 18 years of age and of any race. * Patients with life expectancy longer than or equal to 12 weeks. * Patients with histological or cytological diagnosis of Her-2/neu negative breast adenocarcinoma. * Patients with ability enough to understand the questionnaires. Exclusion Criteria: * Pregnant or lactating women. * Patients who have been treated with chemotherapy in the last three weeks * Patients who refuse to participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.