Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer
NCT ID: NCT03048942
Last Updated: 2019-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
160 participants
INTERVENTIONAL
2014-11-30
2025-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cabazitaxel
6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Cabazitaxel
3 weekly cyctotoxic chemotherapy
Paclitaxel
6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.
Paclitaxel
Weekly cyctotoxic chemotherapy
Interventions
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Cabazitaxel
3 weekly cyctotoxic chemotherapy
Paclitaxel
Weekly cyctotoxic chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
99 Years
FEMALE
No
Sponsors
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University Hospitals Bristol and Weston NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Amit K Bahl
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Bristol and Weston NHS Foundation Trust
Locations
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Imperial Healthcare NHS Trust
London, Avon, United Kingdom
Royal United Hospital
Bath, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Bristol Haematology and Oncology Centre, Horfield Road
Bristol, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Royal Devon and Exeter Hospital
Exeter, , United Kingdom
Guy's Hospital
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
City Hospital, Nottingham
Nottingham, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Musgrove Park Hospital
Taunton, , United Kingdom
Royal Cornwall and Treliske
Truro, , United Kingdom
Worcestershire Acute Hospitals NHS Trust
Worcester, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ON/2012/4234
Identifier Type: -
Identifier Source: org_study_id
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