Clinical trial · Interventional
Adjuvant Albumin-bound Paclitaxel Versus Taxanes in Breast Cancer: a Real-world Study
Adjuvant AC Followed by Albumin-bound Paclitaxel Versus AC Followed by Taxanes in Breast Cancer: a Prospective, Multi-center, Real-world Study
NCT05287308CI-TRIAL-00057444not yet recruitingN/AClinicalTrials.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)
This is a prospective, multi-center, real-world study designed to evaluate the efficacy and safety of albumin-bound paclitaxel versus paclitaxel or docetaxel in adjuvant treatment of breast cancer.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| albumin-bound paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| docetaxel | Drug | Docetaxel | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| epirubicin | Drug | Epirubicin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| pirarubicin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AC followed by albumin-bound paclitaxel
- description
- A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by albumin-bound paclitaxel for 4 cycles.
- interventionNames
- Drug: doxorubicin
- Drug: epirubicin
- Drug: pirarubicin
- Drug: cyclophosphamide
- Drug: albumin-bound paclitaxel
- type
- ACTIVE_COMPARATOR
- label
- AC followed by taxanes
- description
- A (doxorubicin, epirubicin or pirarubicin) and C (cyclophosphamide) for 4 cycles followed by paclitaxel or docetaxel for 4 cycles.
- interventionNames
- Drug: doxorubicin
- Drug: epirubicin
- Drug: pirarubicin
- Drug: cyclophosphamide
- Drug: paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged from 18 to 70 years old; 2. Histologically confirmed as invasive breast cancer; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; 4. Participants achieved complete tumor resection by radical mastectomy, modified radical mastectomy or breast-conserving surgery with negative margins; 5. AC-T adjuvant chemotherapy is planned after breast cancer surgery; 6. Participants with HER-2 negative breast cancer at high risk of recurrence who meet any of the following conditions: 1) HR positive, and ≥4 positive lymph nodes or 1-3 positive lymph nodes with other risk of recurrence \[such as high Ki67 expression (≥20%), T \> 2 cm, age \< 35 years, lymphovascular invasion, grade 3 histology\]; 2) HR negative with positive lymph node or T \> 2 cm; 7. LVEF ≥ 50%; 8. Participants had good compliance with the planned treatment and follow-up, understood the study procedures of this study, and signed informed consent form. Exclusion Criteria: 1. In the past and present, participants with severe cardiac disease or discomfort , including but not limited: 1) High-risk uncontrolled arrhythmia, atrial tachycardia (heart rate \> 100/min in resting state), significant ventricular arrhythmia (ventricular arrhythmia) or higher atrioventricular block (second-degree type 2 \[Mobitz 2\] atrioventricular block or third-degree atrioventricular block); 2) Angina pectoris requiring anti-angina medication; 3) Clinically significant valvular heart disease; 4) ECG showing transmural myocardial infarction; 5) Uncontrolled hypertension (eg systolic blood pressure \> 180mm Hg or diastolic blood pressure \> 100mmHg); 6) Myocardial infarction; 7) Congestive heart failure; 2. Participants who have received prior any systematic treatment for breast cancer; 3. Participants with bilateral invasive breast cancer; 4. Breast cancer with distant metastasis; 5. Grade 2 or higher Sensory or motor neurotoxicity was present as assessed by CTCAE V5.0; 6. Participants have the following serious illnesses or medical conditions, including but not limited: 1) History of serious neurological or psychiatric disorders, including psychosis, dementia, or epilepsy, that prevent understanding and informed consent; 2) Active uncontrolled infection; 3) Active peptic ulcer, unstable diabetes; 7. Previous or current existence of other malignant tumors other than breast cancer; 8. Severe liver and kidney dysfunction; 9. The presence of any myelodysplastic and other hematopoietic disorders; 10. Participants who are known to be allergic to the active or other components of the study treatment; 11. Participants who are pregnant, breastfeeding, or refuse to use adequate contraception prior to study entry and for the duration of study participation; 12. Participants who were judged by the investigator to be unsuitable for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.