Clinical trial · Interventional
Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer
A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer
- 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)
90 patients with HER2 negative breast cancer will be randomised to receive 18 weeks of chemotherapy treatment, either 6 cycles of 3 weekly Cabazitaxel or 6 cycles of weekly Paclitaxel to determine the difference in progression free survival between the 2 groups. If results at that stage suggest a potential benefit then the trial will be developed further to accrue 70 more patients.
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 |
|---|---|---|---|
| HER2 Negative Metastatic Breast Cancer | Breast Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cabazitaxel | Drug | Cabazitaxel | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cabazitaxel
- description
- 6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
- interventionNames
- Drug: Cabazitaxel
- type
- ACTIVE_COMPARATOR
- label
- Paclitaxel
- description
- 6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Progression Free Survival
- timeFrame
- Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Metastatic breast cancer fit to receive cytotoxic chemotherapy for metastatic disease * Measurable disease as per RECIST 1.1 * HER2 negative defined as ICH 0+, 1+ or 2+ and FISH/SISH/CISH(ration\<2.0) in the case of IHC 2+ * ECOG performance status 0 or 1 * ER+ve or ER-ve * Female age ≥18 years * Anticipated life expectancy \> 6 months * Haemoglobin \>10.0g/DL * Absolute neutrophil count\>1.5 x 10\^9/L * Platelet count\>100 x 10\^9/L * ALT/SGPT\<1.5 X ULN * Serum creatinine \<1.5 x ULN * Negative pregnancy test for all women of child bearing potential Exclusion Criteria: * Grade ≥2 oral mucositis or peripheral or sensory neuropathy * History of other malignancy * History of severe hypersensitivity ≥grade 3 to polysorbate 80- containing drugs and taxanes * Clinically significant cardiovascular disease * Any acute or chronic medical condition * Acute infection requiring systemic antibiotics or antifungal medication * Sex hormones * Administration of any live vaccine within 8 weeks * Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 * Participation in another clinical trial with an investigational drug within 30 days of randomisation * Pregnant or breast feeding women * Contraindications to the use of corticosteroid treatment * HER2 Positive breast cancer * Previous Paclitaxel chemotherapy in the adjuvant setting * Previous cytotoxic chemotherapy for metastatic disease * Palliative radiotherapy for metastatic disease within 4 weeks of randomisation * Symptomatic brain metastases confirmed with CT/MRI brain * History of other malignancy * Grade 2
References
Publications (0)
Data not yet available