Clinical trial · Observational
Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice
Retrospective Observational Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Given the infeasibility to achieve the study population together with the loss of originality in the scientific rationale, it was considered to cancel the study
Summary
Brief summary (as posted)
This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice. To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.
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
Design
Arms and outcomes
Arms (1)
- label
- Abraxane® treatment in patients with metastatic breast cancer
- description
- Patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014) and who give their consent to data collection.
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- Up to approximately 8 months
- description
- The number of patients who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria during treatment with nab-paclitaxel until disease progression, the end of treatment or the start of the study, whichever comes first.
Secondary outcomes (6)
- measure
- Overall Response Rate (ORR)
- timeFrame
- Up to approximately 8 months
- description
- The number of patients who achieve a complete response (CR) or partial response (PR) during the first 3 treatment cycles with nab-paclitaxel and the corresponding 95% CI will be calculated.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women ≥18 years of age. * Confirmed diagnosis of MBC (stage IV). * Breast adenocarcinoma confirmed histologically. * HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer. * Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment. * Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given). Exclusion Criteria: * Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent. * Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity. * Patients who have taken part in any clinical trial (interventional) during the study period.
References
Publications (0)
Data not yet available