SYF5bbbad3161c74b1e84624360c1c44067Registry ID: 2024-519364-40-00|Active Not RecruitingPhase 2
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interventional
N/A
1 country
7
Identify molecular markers of therapy response/resistance and survival outcome.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2024
Actual (reported)The primary objective of this trial is to prospectively evaluate the predictive and prognostic value of pre-treatment assessment of a panel of 300 known potential driver mutations in breast cancer by next generation sequencing of tumor DNA.
To assess how genetic/epigenetic disturbances in tumor tissue change during therapy
The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison.
Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A.
To estimate recurrence-free and overall survival when patients are treated with the optimal personalized treatment available as of 2016, using historical data for comparison.
To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
IBRANCE 125 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
IBRANCE 75 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Lynparza 150 mg film-coated tablets
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordFormulated product
IBRANCE 100 mg hard capsules
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CAPSULE, HARD
View registry recordFormulated product
Perjeta 420 mg concentrate for solution for infusion
The registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
IBRANCE 125 mg hard capsules
Named ingredient: palbociclib
View registry recordIBRANCE 75 mg hard capsules
Named ingredient: palbociclib
View registry recordLynparza 150 mg film-coated tablets
Named ingredient: olaparib
View registry recordIBRANCE 100 mg hard capsules
Named ingredient: palbociclib
View registry recordPerjeta 420 mg concentrate for solution for infusion
Named ingredient: pertuzumab
View registry recordHelse Forde HF
Foerde, 6812, Norway
St. Olavs Hospital HF
Trondheim, 7030, Norway
Helse Fonna HF
Haugesund, 5528, Norway
Hanna Elisabet Dillekås
First Submitted
November 1, 2024
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Source retrieved:
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INFUSION
Contact the study team to confirm eligibility.
Universitetssykehuset Nord-Norge HF
Tromsoe, 9019, Norway
Akershus University Hospital
Lorenskog, 1478, Norway
Helse Bergen HF
Bergen, 5021, Norway
Helse Stavanger HF
Stavanger, 4011, Norway