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Head-to-Head: which chemo works better for HER2-Negative breast cancer?

NCT ID NCT03048942

Disease control Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This trial compares two chemotherapy drugs—cabazitaxel given every three weeks versus paclitaxel given weekly—as a first treatment for HER2-negative metastatic breast cancer. About 90 to 160 participants receive 18 weeks of one of the two drugs. The main goal is to see which drug delays cancer growth longer. Researchers also track tumor shrinkage and overall response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
two chemotherapy drugs: cabazitaxel (given every 3 weeks) and paclitaxel (given weekly)
What this could lead to
If cabazitaxel works better than paclitaxel, it could offer a new first-line chemotherapy option for people with HER2-negative metastatic breast cancer.
What could go wrong
This is a phase 2 pilot study with a relatively small number of participants, so results may not be definitive. Both drugs have significant side effects, and cabazitaxel may not prove superior.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

158 people

The number who actually took part.

Started

Dec 2014

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast neoplasm Her2-receptor negative breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

HER2 negative metastatic breast cancer

Contacts and locations

Locations

  • Blackpool Victoria Hospital

    Blackpool, United Kingdom

  • Bristol Haematology and Oncology Centre, Horfield Road

    Bristol, BS2 8ED, United Kingdom

  • City Hospital, Nottingham

    Nottingham, United Kingdom

  • Derriford Hospital

    Plymouth, United Kingdom

  • Freeman Hospital

    Newcastle, United Kingdom

  • Guy's Hospital

    London, United Kingdom

  • Imperial Healthcare NHS Trust

    London, W6 8RF, United Kingdom

  • Musgrove Park Hospital

    Taunton, United Kingdom

  • Royal Cornwall and Treliske

    Truro, United Kingdom

  • Royal Devon and Exeter Hospital

    Exeter, United Kingdom

  • Royal United Hospital

    Bath, United Kingdom

  • Velindre Cancer Centre

    Cardiff, United Kingdom

  • Worcestershire Acute Hospitals NHS Trust

    Worcester, United Kingdom

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