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Gene-Tailored therapy shows promise for aggressive breast cancer

NCT ID NCT02624973

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether giving breast cancer treatment based on each tumor's unique genetic makeup works better than standard therapy. About 200 people with large or aggressive breast tumors will receive a personalized drug plan before surgery. Researchers will track how well the tumors shrink and look for genetic changes to guide future treatments.

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

200 people

The number who actually took part.

Started

Apr 2016

Expected to finish

Jun 2030

An estimate. End dates often move.

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 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: * Previously untreated, histologically confirmed non-inflammatory breast cancer, \>4 cm in diameter and /or metastatic ipsilateral axillary deposits for which the smallest diameter of the largest node \>2 cm by CT or ultrasound scan. * WHO performance status 0-1 * Known tumor ER, PGR, HER2 and TP53 status. * Known tumor Ki67 percentage (if ER/PGR\>50% and TP53 wt status). * Distant metastasis not suspected. Patients will undergo radiology exams during screening phase, after signing the informed consent. * Age \>18 years * Patients must have clinically and/or radiographically documented measurable breast cancer according to RECIST. * Radiology studies (CT thorax/abdomen and bone scintigraphy/bone scan) must be performed within 28 days prior to registration. * Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial * Before patient registration/randomization, written informed consent must be given according to national and local regulations. * For arms B-H: * Neutrophils \> 1.5 x 109/L * Platelets \> 100 x 109/L * Bilirubin \< 2 x upper limit normal (ULN). For patients with Gilbert´s syndrome bilirubin \>2 x ULN is accepted if there is no evidence of biliary obstruction. * Serum creatinine \< 1.5 x ULN * ALT and Alk Phos (ALP) \<2.5 x ULN * INR \< 1.5 Exclusion Criteria: * Unstable angina pectoris or heart failure * Other co-morbidity that, based on the assessment of the treating physician, may preclude the use of chemotherapy at actual doses. * Pregnant or lactating patients can not be included. * Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist. * Patient not able to give an informed consent or comply with study regulations as deemed by study investigator. * Active cystitis (to be treated upfront) * Active bacterial infections * Urinary obstruction

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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

  • Akershus University Hospital

    Lørenskog, Akershus, Norway

  • Haukeland University Hospital

    Bergen, Hordaland, 5021, Norway

  • Helse Fonna

    Haugesund, Rogaland, Norway

  • Helse Førde

    Førde, Sogn Og Fjordande, Norway

  • Helse Nord/UNN

    Tromsø, Troms, Norway

  • Helse Stavanger

    Stavanger, Rogaland, Norway

  • St. Olavs Hospital

    Trondheim, Sør Trøndelag, Norway

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