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New combo aims to tame breast cancer with fewer side effects

NCT ID NCT03264547

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tested whether replacing standard taxane chemotherapy (paclitaxel or docetaxel) with eribulin, when combined with pertuzumab and trastuzumab, could control advanced HER2-positive breast cancer just as well while causing less nerve damage. The study enrolled 446 women who had not received prior chemotherapy for advanced disease. Researchers measured progression-free survival and patient-reported numbness and tingling to compare the two approaches.

What this could mean

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

Active substance
eribulin (Halaven), pertuzumab (Perjeta), trastuzumab (Herceptin)
What this could lead to
If successful, this could offer a new chemotherapy option for advanced HER2+ breast cancer that may cause less nerve damage and improve quality of life.
What could go wrong
This is a completed Phase 3 trial, but results may not show a meaningful benefit over standard taxane therapy, and eribulin has its own side effects like fatigue and low blood counts.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

446 people

The number who actually took part.

Started

Aug 2017

Finished

Dec 2024

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

20 to 70 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: 1. Patients with breast cancer that is confirmed histologically or cytologically 2. Patients who are confirmed to be HER2 positive for the primary or a metastatic lesion at a participating medical institution 3. Patients with no medical history of treatment for advanced/recurrent cancer using a regimen of drugs including chemotherapeutics 4. \>=6 months have passed since perioperative treatment with anticancer agents 5. Presence of a measurable lesion not required 6. Female aged 20-70 years old at the time of consent acquisition 7. Baseline left ventricular ejection fraction (LVEF) measured by ECHO or MUGA of \>=50% 8. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-1 9. Patients who have maintained major organ functions, meeting all of the following criteria on a test within 28 days before enrollment. If there are multiple test results during this period, that obtained immediately before enrollment should be adopted. (1) Neutrophil count: \>=1,500/mm3 (2) Platelet count: \>=100,000/mm 3 (3) Hemoglobin: \>=9.0 g/dL (4) Total bilirubin: \<=1.5 mg/dL (5) AST (GOT), ALT (GPT): \<=2.5 times the ULN (\<=5 times in those with liver metastasis) (6) Serum creatinine: \<=1.5 mg/dL 10) Patients with a life expectancy of at least 6 months 11) Patient who submits written consent herself after receiving sufficient explanation about this study 12) Patients who can undergo QOL investigation Exclusion Criteria: 1. Patients planning to undergo radical surgery if they respond to a treatment 2. Patients who have non-hematological adverse events assessed as Grade \>=3 in the Common Terminology Criteria for Adverse Events ver. 4.0 in the Japanese JCOG version (CTCAE v4.0-JCOG) at the time of enrollment 3. Patients who have symptomatic metastases to the central nervous system or whose symptoms are hard to control 4. Patients who have active double cancer 5. Patients who have poorly controlled hypertension, or unstable angina 6. Patients who have a past history of congestive heart failure assessed as Class ll or higher in the New York Heart Association (NYHA) classification, or clinically significant arrhythmia requiring treatment 7. Patients with a past history of myocardial infarction within 6 months before enrollment 8. Patients who are expected to undergo major surgical treatment or who had severe injury within 28 days before enrollment, or who require major surgical treatment during the study treatment period 9. Patients with interstitial pneumonia which is symptomatic or requires treatment 10. Pregnant women, those with a positive pregnancy test, and lactating women 11. Patients with active systemic infection (including HCV and HBV), or who are found to be HIV-positive 12. Patients with hypersensitivity against pertuzumab and trastuzumab 13. Patients whom the investigator consider unable or unwilling to follow the protocol requirements

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.