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NCT02594371
Ph3 Study To Determine Safety,Tolerability&Tumor Response Of Oraxol Compared To Taxol In Metastatic Breast Cancer
Completed
Phase 3
Last updated 3 August 2022
What this trial tests
Phase 3 trial testing Oraxol in Metastatic Breast Cancer in 402 participants. Completed in 30 June 2022.
Timeline
2 December 2015
Primary endpoint
25 July 2019
25 July 2019
30 June 2022
Quick facts
| Lead sponsor | Athenex, Inc. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 402 |
| Start date | 2 December 2015 |
| Primary completion | 25 July 2019 |
| Estimated completion | 30 June 2022 |
| Sites | 45 locations across Panama, Colombia, Dominican Republic, Ecuador, Peru, Chile, Honduras, El Salvador |
Drugs / interventions tested
- Oraxol — full drug profile →
- IV paclitaxel — full drug profile →
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Sponsor
Athenex, Inc. — full company profile →
Who can join
18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To determine the safety and tolerability of Oraxol as compared to IV paclitaxel in metastatic breast cancer
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
Overcoming negatively charged tissue barriers: Drug delivery using cationic peptides and proteins.
Vedadghavami A, Zhang C, Bajpayee AG. · · 2020 · cited 124× · PMID 32802145 · DOI 10.1016/j.nantod.2020.100898 -
Targeted Oral Delivery of Paclitaxel Using Colostrum-Derived Exosomes.
Kandimalla R, Aqil F, Alhakeem SS, Jeyabalan J, et al · · 2021 · cited 69× · PMID 34359601 · DOI 10.3390/cancers13153700 -
Neutrophil heterogeneity and plasticity: unveiling the multifaceted roles in health and disease.
He W, Yan L, Hu D, Hao J, et al · · 2025 · cited 32× · PMID 39845896 · DOI 10.1002/mco2.70063 -
Open-Label, Randomized, Multicenter, Phase III Study Comparing Oral Paclitaxel Plus Encequidar Versus Intravenous Paclitaxel in Patients With Metastatic Breast Cancer.
Rugo HS, Umanzor GA, Barrios FJ, Vasallo RH, et al · · 2023 · cited 15× · PMID 35858154 · DOI 10.1200/jco.21.02953 -
Novel Quinoline Compound Derivatives of NSC23925 as Potent Reversal Agents Against P-Glycoprotein-Mediated Multidrug Resistance.
Quan X, Du H, Xu J, Hou X, et al · · 2019 · cited 7× · PMID 31921759 · DOI 10.3389/fchem.2019.00820 -
Drug Treatment Direction Based on the Molecular Mechanism of Breast Cancer Brain Metastasis.
Zhang Y, Shang H, Zhang J, Jiang Y, et al · · 2025 · cited 1× · PMID 40006075 · DOI 10.3390/ph18020262 -
A randomized, open-label, two-way crossover clinical trial to evaluate the food effect on pharmacokinetics and safety of DHP107 in patients with advanced solid tumors: the FEEL study.
Hitre E, Láng I, Páll D. · · 2026 · PMID 42215716 · DOI 10.1007/s00280-026-04887-9
Verify or expand the search:
- PubMed search for NCT02594371
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Oraxol
Trials testing the same drug.
- NCT03892018 — The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol · Phase 1 · terminated
- NCT04993040 — A PK Study of Oraxol in Breast Cancer Patients · Phase 1 · completed
- NCT03544567 — A Study of Oraxol in Subjects With Cutaneous Angiosarcoma · Phase 2 · completed
- NCT03588039 — Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors · Phase 1 · terminated
- NCT04168957 — An Extension Study to Provide Oraxol to Patients Who Completed KX-ORAX-007 · Phase 1 · terminated
Other recruiting trials for Metastatic Breast Cancer
Currently open trials in the same condition.
- NCT07524855 — A Study of HLD-0117 in Patients With Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07408089 — Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer · Phase 1 · recruiting
- NCT07340541 — Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies · Phase 2 · recruiting
- NCT07233928 — Breast Cancer Organelle Properties and Protein Expression Atlas in the Three Immunohistochemical Subtypes of Breast Canc · NA · recruiting
- NCT07347600 — A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, · recruiting
Other Athenex, Inc. trials
Trials by the same sponsor.
- NCT04136834 — A Phase I Open-label Study for Subjects With Advanced Malignancies · Phase 1 · unknown
- NCT03892018 — The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol · Phase 1 · terminated
- NCT04993040 — A PK Study of Oraxol in Breast Cancer Patients · Phase 1 · completed
- NCT03544567 — A Study of Oraxol in Subjects With Cutaneous Angiosarcoma · Phase 2 · completed
- NCT03588039 — Study of Oraxol and Pembrolizumab in Subjects With Advanced Solid Tumors · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT02594371 (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 Athenex, Inc.
- Last refreshed: 3 August 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/NCT02594371.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing