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Can imaging cut chemo for breast cancer? new trial seeks answers

NCT ID NCT03820063

Disease control Sponsor: Borstkanker Onderzoek Groep 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This phase 2 trial is testing whether doctors can safely reduce the amount of chemotherapy given to people with HER2-positive breast cancer by using imaging scans to guide treatment. The study involves 462 participants with stage II or III disease who receive a combination of drugs (paclitaxel, trastuzumab, carboplatin, and pertuzumab) before surgery. If the cancer responds well on scans, less chemo may be needed, potentially lowering side effects while still aiming for a good outcome.

What this could mean

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

Active substance
Paclitaxel, trastuzumab (Herceptin), carboplatin, pertuzumab, and T-DM1
What this could lead to
If successful, this could show that some patients with HER2-positive breast cancer can safely receive less chemotherapy, reducing side effects without compromising outcomes.
What could go wrong
This is a phase 2 trial with 462 participants, so results are preliminary. The approach may not work for all patients, and there is still a risk of cancer recurrence or side effects from the drugs.

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

About 462 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2019

Expected to finish

May 2032

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

18 years and older

Sex

Anyone

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. Histologically confirmed primairy infiltrating breast cancer. 2. Stage II or Ill disease. 3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy. 4. Age \<:18 5. ECOG Group performance status 6. LVEF \>50% measured by echocardiography, MRI or MUGA 7. Known HR-status ( in percentages) Exclusion Criteria: 1. Previous radiation therapy of chemotherapy 2. Pregnancy or breastfeeding 3. Evidence of distant metastases 4. Evidence of bilateral infiltrating breast cancer 5. Concurrent anti-cancer treatment or another investigational drug

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Alexander Monro ziekenhuis

    Bilthoven, Netherlands

  • Amphia Ziekenhuis

    Breda, Netherlands

  • Amsterdam UMC

    Amsterdam, Netherlands

  • Bernhoven

    Oss, Netherlands

  • Canisius Wilhelmina Ziekenhuis

    Nijmegen, Netherlands

  • Catharina ziekenhuis

    Eindhoven, Netherlands

  • Deventer ziekenhuis

    Deventer, Netherlands

  • Diakonessenhuis Utrecht

    Utrecht, Netherlands

  • Elisabeth TweeSteden ziekenhuis

    Tilburg, Netherlands

  • Elkerliek ziekenhuis

    Helmond, Netherlands

  • Erasmus MC, Universitair Medisch Centrum Rotterdam

    Rotterdam, Netherlands

  • Franciscus Gasthuis en Vlietland

    Rotterdam, Netherlands

  • Gelre ziekenhuizen

    Apeldoorn, Netherlands

  • Groene Hart Ziekenhuis

    Gouda, Netherlands

  • Haaglanden MC

    The Hague, Netherlands

  • Haga Ziekenhuis

    The Hague, Netherlands

  • Ikazia Ziekenhuis

    Rotterdam, Netherlands

  • Isala Klinieken

    Zwolle, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, Netherlands

  • Laurentius ziekenhuis

    Roermond, Netherlands

  • MUMC

    Maastricht, Netherlands

  • Maasstadziekenhuis

    Rotterdam, Netherlands

  • Martini ziekenhuis

    Groningen, Netherlands

  • Maxima Medisch Centrum

    Eindhoven, Netherlands

  • Meander Medisch Centrum

    Amersfoort, Netherlands

  • Medisch Centrum Leeuwarden

    Leeuwarden, Netherlands

  • NKI-AVL

    Amsterdam, Netherlands

  • Nij Smellinghe

    Drachten, Netherlands

  • Noordwest Ziekenhuisgroep

    Alkmaar, Netherlands

  • OLVG

    Amsterdam, Netherlands

  • RIVAS Beatrixziekenhuis

    Gorinchem, Netherlands

  • Reinier de Graaf Groep

    Delft, Netherlands

  • Rijnstate

    Arnhem, Netherlands

  • Rivierenland Ziekenhuis

    Tiel, Netherlands

  • Rode Kruis Ziekenhuis

    Beverwijk, Netherlands

  • SKB Ziekenhuis Winterswijk

    Winterswijk, Netherlands

  • Sint Annaziekenhuis

    Geldrop, Netherlands

  • Sint Antonius ziekenhuis

    Nieuwegein, Netherlands

  • Spaarne Gasthuis

    Hoofddorp, Netherlands

  • Stichting ziekenhuizen West-Friesland en Waterland

    Purmerend, Netherlands

  • Tergooi

    Hilversum, Netherlands

  • Tjongerschans

    Heerenveen, Netherlands

  • Universitair Medisch Centrum Utrecht

    Utrecht, Netherlands

  • VieCurie Medisch Centrum voor Noord-Limburg

    Venlo, Netherlands

  • Zaans Medisch Centrum

    Zaandam, Netherlands

  • Ziekenhuis Amstelland

    Amstelveen, Netherlands

  • Ziekenhuis St. Jansdal

    Harderwijk, Netherlands

  • Ziekenhuisgroep Twente

    Almelo, Netherlands

  • Ziekenhuisvoorziening Gelderse Vallei

    Ede, Netherlands

  • ZorgSaam

    Terneuzen, Netherlands

  • Zuyderland Medisch Centrum

    Heerlen, Netherlands

  • van Weel Bethesda

    Dirksland, Netherlands

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