Cabazitaxel
| Evidence Level: L5 | Predicted Indications: 10 |
Table of Contents
- Cabazitaxel
- Pharmacist Assessment Report
- Cabazitaxel: From Cancer Treatment to Female Breast Carcinoma
- One-Sentence Summary
- Quick Overview
- Why is This Prediction Reasonable?
- Clinical Trial Evidence
- Literature Evidence
- India Market Information
- Cytotoxicity
- Safety Considerations
- Conclusion and Next Steps
- Disclaimer
Cabazitaxel: From Cancer Treatment to Female Breast Carcinoma
One-Sentence Summary
Cabazitaxel is a taxane-class cytotoxic injection marketed in India, and the data compiled for this report do not state its approved indication text. The TxGNN model predicts it may be effective for female breast carcinoma, but no clinical trials are registered in the data and the supporting literature (20 publications) is mostly preclinical formulation work and reviews. The only clinical studies are the Phase II GENEVIEVE trial and a Phase I/II combination study.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the available data (licence records contain no indication text) |
| Predicted New Indication | Female breast carcinoma |
| TxGNN Prediction Score | 0.9992 |
| Evidence Level | L5 |
| India Market Status | Listed in a compiled Indian medicine price dataset (9 of 9) – CDSCO approval status is not included in this data |
| Number of Listed Products | 9 (valid: 9) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the compiled record. Based on known pharmacology, cabazitaxel is a taxane that stabilises microtubules and causes mitotic arrest. The supporting literature describes it as a weaker substrate for the P-glycoprotein efflux pump than paclitaxel and docetaxel, so it may retain activity in taxane-resistant tumours.
Taxanes (paclitaxel, docetaxel) are already established in breast cancer treatment. A drug of the same class that is less affected by efflux-mediated resistance is a plausible candidate for breast cancer, especially after prior taxane exposure.
This link is mechanistic and class-based. The clinical evidence for cabazitaxel itself in breast cancer is limited to early-phase and one randomised Phase II study (see below), so the prediction should be treated as a research question rather than a confirmed new use.
Clinical Trial Evidence
Currently no related clinical trials are registered in the compiled data.
The literature section below does describe two clinical studies identified through publications.
Literature Evidence
Listed in priority order (clinical studies first, then reviews, then preclinical work).
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 28768217 | 2017 | Randomised Phase II | Eur J Cancer | GENEVIEVE: neoadjuvant cabazitaxel vs weekly paclitaxel in HER2-negative (triple-negative or luminal B) operable breast cancer, with pathological complete response as the primary endpoint |
| 38663168 | 2024 | Randomised Phase II (long-term follow-up) | ESMO Open | Long-term outcomes of GENEVIEVE; earlier pCR differences were reported and long-term effects were being assessed |
| 21339064 | 2011 | Phase I/II | Eur J Cancer | Cabazitaxel plus capecitabine in metastatic breast cancer progressing after anthracycline and taxane; assessed maximum tolerated dose, safety, pharmacokinetics and activity |
| 25416788 | 2015 | Review / resistance study | Mol Cancer Ther | Cabazitaxel was less cross-resistant than paclitaxel and docetaxel in multidrug-resistant models, including MCF-7 breast cancer variants |
| 21076710 | 2010 | Review | Drugs Today | Cabazitaxel has a favourable pharmacokinetic and safety profile and reduced susceptibility to P-gp-mediated resistance; neutropenia and neuropathy are main toxicities |
| 33753567 | 2021 | Preclinical | J Immunother Cancer | Cabazitaxel’s effect on macrophages improves CD47-targeted immunotherapy in triple-negative breast cancer |
| 30529259 | 2019 | Preclinical | J Control Release | Cabazitaxel-loaded nanoparticles gave complete remission in 6 of 8 tumours in a patient-derived breast cancer xenograft, better than free drug |
| 30521787 | 2019 | Preclinical | Chem Phys Lipids | Cabazitaxel and thymoquinone co-loaded lipospheres as a synergistic combination for breast cancer |
| 33360926 | 2021 | Preclinical | Colloids Surf B | Cabazitaxel-loaded nanostructured lipid carriers evaluated against breast cancer cell lines |
| 28504249 | 2017 | Preclinical | Acta Pharmacol Sin | Cabazitaxel-loaded polymeric micelles for treating breast cancer metastasis |
India Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 17021 | Arbaz 60mg Injection | Vial of 1.5 ml injection | Not stated |
| 52984 | Cabocyta 60mg Injection | Vial of 1.5 ml injection | Not stated |
| 250150 | Z-Texel Injection | Vial of 1.5 ml powder for injection | Not stated |
| 48705 | Cabazirix 60mg Injection | Vial of 1 injection | Not stated |
| 42803 | Cabaxan Injection | Vial of 1.5 ml injection | Not stated |
Nine valid single-ingredient registrations exist in total; the five above are shown.
Cytotoxicity
| Item | Content |
|---|---|
| Cytotoxicity Classification | Conventional cytotoxic (taxane, microtubule inhibitor) |
| Myelosuppression Risk | High (neutropenia is a leading toxicity; the knowledge graph also links the drug to thrombocytopenia, leukopenia, anaemia and agranulocytosis as contraindicated conditions) |
| Emetogenicity Classification | Please refer to the package insert warnings and precautions |
| Monitoring Items | Complete blood count with differential, liver function (bilirubin), renal function |
| Handling Protection | Must follow cytotoxic drug handling regulations |
Safety Considerations
- Disease-level contraindication signals (from a knowledge graph, not label text): kidney disease, liver disease, gallbladder disease, hyperbilirubinaemia (including hereditary forms and Gilbert syndrome), thrombocytopenia, neutropenia, agranulocytosis, leukopenia, anaemia and macrocytic anaemia, and pyoureter.
- Drug Interactions (100 interactions recorded; examples shown):
- Major: deferiprone, samarium (153Sm) lexidronam
- Moderate: aprepitant, clarithromycin, clotrimazole, metronidazole, miconazole, rosuvastatin, simvastatin, tinidazole, troglitazone, cobicistat, deferasirox, ticagrelor, chloroquine, disulfiram
Please refer to the package insert for official warnings and contraindications, which were not available for this report.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction is mechanistically plausible and one randomised Phase II study exists in HER2-negative breast cancer, but there are no registered trials in the data, no approved-indication text, and no package insert safety information. The evidence is at the L4 level and the product carries substantial myelosuppression risk.
To proceed, the following is needed:
- Package insert warnings and contraindications for the Indian products (a blocking gap for safety screening)
- Approved indication text from the Indian licences
- Mechanism of action data from DrugBank
- Review of the full GENEVIEVE results (pCR and long-term outcomes) and of the Phase I/II combination data
- Search for registered breast cancer trials of cabazitaxel
- A safety and monitoring plan for myelosuppression, hepatic impairment and interacting drugs (especially CYP3A-related interactions)
The other predicted indications (sickle cell syndromes, HIV, hyperthyroidism, neuroblastoma, rheumatoid arthritis) have no trials or literature in the data and no evident mechanistic rationale, so they are not recommended for further evaluation at this stage.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.