Gene-Tailored therapy shows promise for aggressive breast cancer
NCT ID NCT02624973
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a faster radiation course match the standard one after breast reconstruction?
- Can High-Risk breast cancer patients skip an extra radiation boost?
- Radioactive probe lights up CD73 on breast tumors in PET scans
- Can time with horses help cancer patients feel better?
- Can an oral drug replace injections for advanced breast cancer?
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?