HER2 Negative Metastatic Breast CancerPhase 2CONCEPTNCT03048942

Pilot Study of Cabazitaxel and Paclitaxel in HER2 Negative Breast Cancer

A Phase 2 study testing Cabazitaxel and Paclitaxel in people with HER2 Negative Metastatic Breast Cancer, run by University Hospitals Bristol and Weston NHS Foundation Trust at 13 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 99 years, women only
Conditions the study is for: HER2 Negative Metastatic Breast Cancer
What is being tested?: Cabazitaxel and Paclitaxel
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 158 participants
Where: 13 sitesUnited Kingdom
Study dates: 18 Dec 2014to 19 Mar 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 14Show fewer

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

Who cannot join

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

Show all 19Show fewer

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United Kingdom13 sites

Royal United Hospital
Bath
Blackpool Victoria Hospital
Blackpool
Bristol Haematology and Oncology Centre, Horfield Road
Bristol, BS2 8ED
Velindre Cancer Centre
Cardiff
Royal Devon and Exeter Hospital
Exeter
Imperial Healthcare NHS Trust
London, W6 8RF
Guy's Hospital
London
Freeman Hospital
Newcastle
City Hospital, Nottingham
Nottingham
Derriford Hospital
Plymouth
Musgrove Park Hospital
Taunton
Royal Cornwall and Treliske
Truro
Worcestershire Acute Hospitals NHS Trust
Worcester

Other trials in United Kingdom

About this study

Official title: A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer

Read the detailed description

This is a prospective multicentre, randomised, open label, study comparing the efficacy and the safety of six 3-weekly cycles cabazitaxel versus 18 x weekly paclitaxel given as first line chemotherapy treatment in patients with HER2-normal metastatic breast cancer. Randomisation will be conducted by a 1:1 ratio.

Conditions: HER2 Negative Metastatic Breast Cancer
Being tested: Cabazitaxel, Paclitaxel
Keywords: Breast cancer, HER2 negative, Cabazitaxel, Paclitaxel, Chemotherapy
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CabazitaxelDrug
Also called Jevtana
3 weekly cyctotoxic chemotherapy
PaclitaxelDrug
Weekly cyctotoxic chemotherapy

Study groups in NCT03048942
Study group	Role	What they receive
Cabazitaxel	Experimental	6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle Receives: Drug: Cabazitaxel
Paclitaxel	Active comparator	6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle. Receives: Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression Free Survival
Duration of progression free survival
Measured: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.

Secondary outcomes (8)

Clinical Benefit Rate
Defined as stable disease rate + partial response rate+complete response rate according to RECIST 1.1 criteria
Measured: At the completion of 6 cycles of chemotherapy, which is after 18 weeks
Objective Response Rate
Objective response rate (ORR) is defined as complete response (CR) plus partial response (PR) as per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan every 6 weeks. Tumours were assessed at baseline and compared to the response seen at the completion of treatment. Only responses seen within the 6 cycles of treatment e.g. up to and including the end of treatment tumour assessment are included in this measure.
CR - Disappearance of all target lesions; PR >=30% decrease in the sum of the longest diameter of target lesions.
Measured: At completion of 6 cycles of chemotherapy, which is after 18 weeks.
Overall Survival
Survival duration from randomisation to date of death.
Measured: Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.
Time to Next Chemotherapy Treatment
time from randomisation to another chemotherapy treatment after confirmed progression.
Measured: Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.
Time to Response
Time taken for tumour burden to respond to treatment
Measured: Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.
Assessment of EQ-5D-5L Questionnaire
EQ-5D-5L will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment. The patients answer 5 questions which have 5 possible answers from no issue to extreme issue. The answers are given a code, 1, 2, 3, 4 or 5 with 1 for no issue through to 5 for extreme issues which results in a 5 digit 'health state' for that time point. Using a formula this is translated into the 'EQ-5D index value' where 1 is full health and 0 is the worst health. This is what is presented here, the lower the score the worse the quality of life.
Measured: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
Assessment of EQ-5D-5L VAS Score
EQ-5D-5L VAS score was assessed at baseline, prior to cycle 3 and 5 and at the end of treatment. Patients are asked to score their health on a scale 0-100, the higher the score the better they are feeling.
Measured: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
Assessment of FACT-B Questionnaire
FACT-B will be assessed at baseline, prior to cycle 3 and cycle 5 and at the end of treatment. The patients answer 37 questions which have 5 possible answers from not at all to very much. The answers are given a code, 0, 1, 2, 3 or 4 with 0 for not at all through to 4 for very much. The scores are reversed and then totalled to give a value out of 148. This is what is presented here, the higher the score the better the quality of life.
Measured: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Dec 201419 Mar 2025

First posted9 Feb 2017 (estimated)
Study start18 Dec 2014
Primary completion26 Apr 2021
Study completion19 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HER2 Negative Metastatic Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 158 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03048942
Sponsor's protocol ID: ON/2012/4234
Acronym: CONCEPT
Status last verified: Mar 2026
First submitted: 30 Oct 2014
Last updated: 21 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised Phase II Pilot Study of 3 Weekly Cabazitaxel Versus Weekly Paclitaxel Chemotherapy in the First Line Treatment of HER2 Negative Breast Cancer
ClinicalTrials.gov ID: NCT03048942
Acronym / sponsor ID: CONCEPT / ON/2012/4234
Conditions: HER2 Negative Metastatic Breast Cancer
Keywords: Breast cancer, HER2 negative, Cabazitaxel, Paclitaxel, Chemotherapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 158 participants (actual)
Lead sponsor: University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
Study start: 18 Dec 2014 (actual)
Primary completion: 26 Apr 2021 (actual)
Study completion: 19 Mar 2025 (actual)
First posted: 9 Feb 2017 (estimated)
Results: Posted 21 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cabazitaxel	Experimental	Drug: Cabazitaxel6 cycles of cabazitaxel intravenous chemotherapy 25mg/m2 on day 1 of each 21 day cycle
Paclitaxel	Active comparator	Drug: Paclitaxel6 cycles of Paclitaxel intravenous chemotherapy 80mg/m2 on days 1,8 and 15 of each 21 day cycle.

Who may qualify

Ages: 18 to 99 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

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

Key exclusion criteria (19 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CabazitaxelAlso: Jevtana3 weekly cyctotoxic chemotherapy	Drug	Cabazitaxel
PaclitaxelWeekly cyctotoxic chemotherapy	Drug	Paclitaxel

Primary outcome

Progression Free Survival
Time frame: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.
Duration of progression free survival

8 secondary outcomes

Clinical Benefit Rate
Time frame: At the completion of 6 cycles of chemotherapy, which is after 18 weeks
Objective Response Rate
Time frame: At completion of 6 cycles of chemotherapy, which is after 18 weeks.
Overall Survival
Time frame: Determined as the time from randomisation to death from any cause. Average survival rates for this population may be approximately 18 months.
Time to Next Chemotherapy Treatment
Time frame: Measured from from the date of the last day of trial treatment. approximately after progression which on average would be after 12 months.
Time to Response
Time frame: Determined by time from randomisation to radiological partial response. This was sometimes seen after treatment end but all responses occurred by 8 months from randomisation therefore within 32 weeks.
Assessment of EQ-5D-5L Questionnaire
Time frame: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
Assessment of EQ-5D-5L VAS Score
Time frame: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)
Assessment of FACT-B Questionnaire
Time frame: EQ5D-5L and FACT B will be completed at baseline, prior to cycle 3 (approximately Day 63), prior to cycle 5 (approximately Day 105) and at the end of treatment visit, (approximately 21 weeks)

Results and safety

Results posted to the registry on 21 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cabazitaxel	79	79
Paclitaxel	79	79

Primary outcome: Progression Free Survival

Time frame: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.. Median (95% Confidence Interval). Unit: months

Measure	Cabazitaxel n = 79	Paclitaxel n = 79
Value	6.7 (5.4 to 7.6)	5.8 (4.6 to 6.9)

Cabazitaxel vs Paclitaxel: Hazard Ratio (HR): 0.86 (95% CI 0.62 to 1.19), p = 0.4, Regression, Cox

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse Events were monitored/assessed up to 6 months, from cycle 1 day 1 until 30 days after the last dose of chemotherapy. All-Cause Mortality was monitored/assessed up to 5 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cabazitaxel	27 of 79 (34.2%)	79 of 79 (100%)	69 of 79
Paclitaxel	24 of 79 (30.4%)	79 of 79 (100%)	70 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Amit K Bahl principal investigator

University Hospitals Bristol and Weston NHS Foundation Trust

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (time frame: Defined as the time from randomisation to either disease progression or death from any cause, whichever came first, assessed up to 5 years.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03048942.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.