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NCT04192331
Nab-paclitaxel Dose Schedual for HER-2 Negative Advanced Breast Cancer
Phase 2 trial testing nab-paclitaxel regimen1 in Breast Cancer in 97 participants. Status unknown.
26 January 2023
Quick facts
| Lead sponsor | Peking University Cancer Hospital & Institute |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 97 |
| Start date | 21 February 2019 |
| Primary completion | 26 January 2023 |
| Estimated completion | 26 January 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- nab-paclitaxel regimen1 — full drug profile →
- nab-paclitaxel regimen2 — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
Sponsor
Peking University Cancer Hospital & Institute
Who can join
18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
What is the best dosage of Nab-Paclitaxel for chinese? This study would divide patients into two dosage groups: 1) 125mg/m2, 30 minutes intravenous injection, d1, 8, 21 days for a cycle(clinical use); 2) 125mg/m2 d1, 8, 15, 30 minutes intravenous injection, 28 days for a cycle(guideline recommand). Treatment to disease progression. The efficacy (CR, PR, SD, PD) is evaluated every 2-4 cycles.If the patient withdraws from the trial because he cannot tolerate the toxicity caused by one of the drugs, such as neurotoxicity or bone marrow toxicity, it is recommended to switch to other drugs and follow up to PFS and OS.Each group was planned to include 30 patients.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Substances of Natural Origin in Medicine: Plants vs. Cancer.
Gielecińska A, Kciuk M, Mujwar S, Celik I, et al · · 2023 · cited 39× · PMID 37048059 · DOI 10.3390/cells12070986 -
Three-Week Versus 4-Week Schedule of nab-Paclitaxel in Patients With Metastatic Breast Cancer: A Randomized Phase II Study.
Liu Y, Song G, Di L, Jiang H, et al · · 2023 · cited 2× · PMID 37882706 · DOI 10.1093/oncolo/oyad288
Verify or expand the search:
- PubMed search for NCT04192331
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Peking University Cancer Hospital & Institute trials
Trials by the same sponsor.
- NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im · Phase 2 · not yet recruiting
- NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
- NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
- NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
- NCT07394192 — Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-I · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04192331 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University Cancer Hospital & Institute
- Last refreshed: 13 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04192331.
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