FrancophonIA/ELRC3.0 huggingface dataset:
English: 6.6 Special precautions for disposal and other handling Appropriate aseptic technique should be used for reconstitution and dilution procedures.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Za postopek rekonstitucije in redčenja je treba uporabiti ustrezno aseptično tehniko.
English: This condition may be harmful to your baby in the womb and has been associated with the lungs not developing fully resulting in foetal death.
Slovenian: Tako stanje lahko škodi otroku v maternici in je povezano z nedozorelostjo pljuč ter lahko privede do plodove smrti.
English: Trastuzumab has been investigated in one randomised, open-label phase III trial ToGA (BO18255) in combination with chemotherapy versus chemotherapy alone.
Slovenian: Trastuzumab so proučevali v randomiziranem, odprtem preskušanju faze III ToGA (BO18255) v kombinaciji s kemoterapijo v primerjavi s samo kemoterapijo.
English: Study JP19959 was a substudy of BO18255 (ToGA) performed in male and female Japanese patients with advanced gastric cancer to study the pharmacokinetics of capecitabine and cisplatin when used with or without trastuzumab.
Slovenian: Študija JP19959 je bila podštudija BO18255 (ToGA) pri japonskih bolnikih in bolnicah z napredovalim rakom želodca, v kateri so proučevali farmakokinetiko kapecitabina in cisplatina s trastuzumabom ali brez njega.
English: Trastuzumab may persist in the circulation for up to 7 months after stopping KANJINTI treatment based on population pharmacokinetic analysis of all available data (see section 5.2).
Slovenian: Trastuzumab je lahko po prenehanju zdravljenja z zdravilom KANJINTI v krvnem obtoku prisoten do 7 mesecev glede na populacijsko farmakokinetično analizo vseh razpoložljivih podatkov (glejte poglavje 5.2).
English: Positive
Slovenian: pozitivno
English: + Denotes adverse reactions that have been reported in association with a fatal outcome.
Slovenian: + Označuje neželene učinke, o katerih so poročali v povezavi s smrtnim izidom.
English: In rare cases, a reduction in the amount of (amniotic) fluid that surrounds the developing baby within the womb has been observed in pregnant women receiving trastuzumab.
Slovenian: V redkih primerih so pri nosečnicah, ki so prejemale trastuzumab, opazili zmanjšanje količine (amnijske) tekočine, ki obdaja razvijajočega se otroka v maternici.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo.
English: For early breast cancer, metastatic breast cancer and metastatic gastric cancer, KANJINTI is given every 3 weeks.
Slovenian: Pri zgodnji obliki raka dojk, metastatskem raku dojk in metastatskem raku želodca se zdravilo KANJINTI daje vsake 3 tedne.
English: After aseptic dilution in polyvinylchloride, polyethylene or polypropylene bags containing sodium chloride 9 mg/mL (0.9%) solution for injection, chemical and physical stability of KANJINTI has been demonstrated for up to 30 days at 2°C - 8°C, and subsequently for 24 hours at temperatures not exceeding 30°C.
Slovenian: Po aseptičnem redčenju v polivinilkloridnih, polietilenskih ali polipropilenskih vrečkah, ki vsebujejo raztopino 9 mg/ml (0,9 %) natrijevega klorida za injiciranje, je kemijska in fizikalna stabilnost zdravila KANJINTI dokazana do 30 dni pri temperaturi 2 °C-8 °C in kasneje 24 ur pri temperaturah, ki ne presežejo 30 °C.
English: The frequency of progression in the liver was significantly reduced in patients treated with the combination of trastuzumab and paclitaxel, compared to paclitaxel alone (21.8% versus 45.7%; p = 0.004).
Slovenian: Pogostnost napredovanja v jetrih je bila signifikantno zmanjšana pri bolnikih, zdravljenih s kombinacijo trastuzumaba in paklitaksela, v primerjavi s samim paklitakselom (21,8 % v primerjavi s 45,7 %; p = 0,004).
English: Most of the patients (79%) who developed cardiac dysfunction in these trials experienced an improvement after receiving standard treatment for CHF.
Slovenian: Pri večini bolnikov (79 %), pri katerih so se pojavile motnje v delovanju srca v teh preskušanjih, je prišlo do izboljšanja po standardnem zdravljenju za kongestivno srčno popuščanje.
English: The rate of asymptomatic cardiac dysfunction was increased in the 2-year treatment arm (8.1% versus 4.6% in the 1-year treatment arm).
Slovenian: Delež asimptomatskih motenj v delovanju srca je bil večji v skupini z dvoletnim zdravljenjem (8,1 % v primerjavi s 4,6 % v skupini z enoletnim zdravljenjem).
English: In patients receiving trastuzumab after completion of adjuvant chemotherapy the risk of cardiac dysfunction was associated with a higher cumulative dose of anthracycline given prior to initiation of trastuzumab and a body mass index (BMI) > 25 kg/m2.
Slovenian: Pri bolnikih, ki so prejemali trastuzumab po zaključku adjuvantne kemoterapije, je bilo tveganje za pojav motnje v delovanju srca povezano z višjim kumulativnim odmerkom antraciklina, ki so ga dajali pred uvedbo trastuzumaba in visokim indeksom telesne mase (body mass index - BMI) > 25 kg/m2.
English: In the ToGA (BO18255) trial, patients whose tumours were either IHC3+ or FISH positive were defined as HER2 positive and thus included in the trial.
Slovenian: V preskušanju ToGA (BO18255) so bolnike, katerih tumorji so bili IHC3+ ali FISH pozitivni, definirali kot HER2 pozitivne in jih vključili v preskušanje.
English: The highest rate of cardiac dysfunction was seen in patients receiving trastuzumab concurrently with anthracycline/cyclophosphamide (27%), and was significantly higher than for anthracycline/cyclophosphamide alone (7%-10%).
Slovenian: Najvišji delež motenj v delovanju srca je bil pri bolnikih, ki so trastuzumab prejemali sočasno z antraciklinom/ciklofosfamidom (27 %), bil je signifikantno višji kot pri jemanju samega antraciklina/ciklofosfamida (7 do 10 %).
English: Negative
Slovenian: negativno
English: If you have metastatic or early breast cancer You will be given KANJINTI on either a three-weekly or once weekly cycle.
Slovenian: Če imate metastatsko ali zgodnjo obliko raka dojk Zdravilo KANJINTI boste prejeli vsake tri tedne ali enkrat na teden.
English: If anthracyclines are used, the patient's cardiac function should be monitored carefully.
Slovenian: Če bolnika zdravimo z antraciklini, je treba skrbno spremljati delovanje njegovega srca.
English: Observation N = 1697***
Slovenian: opazovanje n = 1.697***
English: Trastuzumab 1 Year N = 1,702***
Slovenian: 1 leto n = 1.702***
English: Long term follow-up efficacy analysis**
Slovenian: Dolgoročno spremljanje**
English: The addition of trastuzumab to paclitaxel chemotherapy also resulted in a 37% decrease in the risk of death.
Slovenian: Dodatek trastuzumaba kemoterapiji s paklitakselom je hkrati zmanjšal tudi tveganje za smrt za 37 %.
English: A: doxorubicin; C: cyclophosphamide; P: paclitaxel; H: trastuzumab * At median duration of follow-up of 1.8 years for the patients in the AC→P arm and 2.0 years for patients in the AC→PH arm ** p value for OS did not cross the pre-specified statistical boundary for comparison of AC→PH vs AC→P
Slovenian: A: doksorubicin; C: ciklofosfamid; P: paklitaksel; H: trastuzumab; IZ: interval zaupanja * Po mediani spremljanja 1,8 leta za bolnike v skupini AC → P in 2,0 leta za bolnike v skupini AC → PH. ** Vrednost p za celokupno preživetje ni presegla vnaprej določene statistične meje za primerjavo AC → PH z AC → P.
English: For any other method that may be used for the assessment of HER2 protein or gene expression, the analyses should only be performed by laboratories that provide adequate state-of-the-art performance of validated methods.
Slovenian: Analize za katero koli drugo metodo, ki se lahko uporablja za oceno ekspresije beljakovine ali gena HER2, lahko izvajajo le laboratoriji, ki uporabljajo ustrezne sodobne validirane metode.
English: After aseptic reconstitution with sterile water for injections, chemical and physical stability of the reconstituted solution has been demonstrated for 48 hours at 2°C - 8°C.
Slovenian: Po aseptični rekonstituciji s sterilno vodo za injekcije je kemijska in fizikalna stabilnost rekonstituirane raztopine dokazana za 48 ur pri temperaturi od 2 °C - 8 °C.
English: There is no fertility data available.
Slovenian: Podatkov o vplivu na plodnost ni.
English: Total CL range from Cmax,ss to Cmin,ss
Slovenian: Obseg celokupnega očistka od Cmax, ss do Cmin, ss
English: - in combination with neoadjuvant chemotherapy followed by adjuvant KANJINTI therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter (see sections 4.4 and 5.1).
Slovenian: - v kombinaciji z neoadjuvantno kemoterapijo, čemur sledi adjuvantno zdravljenje z zdravilom KANJINTI, za lokalno napredovalo (tudi vnetno) bolezen ali tumorje > 2 cm v premeru (glejte poglavji 4.4 in 5.1).
English: Like all medicines, KANJINTI can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi zdravilo KANJINTI neželene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Patients who had previously received anthracycline-based adjuvant chemotherapy were treated with paclitaxel (175 mg/m2 infused over 3 hours) with or without trastuzumab.
Slovenian: Bolnike, ki so predhodno prejemali adjuvantno kemoterapijo na osnovi antraciklinov, so zdravili s paklitakselom (175 mg/m2, infundirano v 3 urah) samim ali skupaj s trastuzumabom.
English: Congestive heart failure (NYHA class II - IV) is a common adverse reaction associated with the use of trastuzumab and has been associated with a fatal outcome (see section 4.4).
Slovenian: Kongestivno srčno popuščanje, NYHA razred II-IV, je pogost neželeni učinek, povezan z uporabo trastuzumaba; povezan je bil tudi s smrtnim izidom (glejte poglavje 4.4).
English: No incompatibilities between KANJINTI and polyvinylchloride, polyethylene or polypropylene bags have been observed.
Slovenian: Med zdravilom KANJINTI in polivinilkloridnimi, polietilenskimi ali polipropilenskimi vrečkami inkompatibilnosti niso opazili.
English: Detection of HER2 overexpression or HER2 gene amplification
Slovenian: Ugotavljanje čezmernega izražanja HER2 ali amplifikacije gena HER2
English: In a method comparison study (study D008548) a high degree of concordance (> 95%) was observed for SISH and FISH techniques for the detection of HER2 gene amplification in gastric cancer patients.
Slovenian: V študiji za primerjavo metod (študija D008548) so med tehnikama SISH in FISH za ugotavljanje amplifikacije gena HER2 pri bolnikih z rakom želodca ugotovili visoko stopnjo ujemanja (> 95 %).
English: There is no experience with overdose in human clinical trials.
Slovenian: Izkušenj s prevelikim odmerjanjem v kliničnih preskušanjih pri ljudeh nimamo.
English: • you are allergic to trastuzumab, to murine (mouse) proteins, or to any of the other ingredients of this medicine (listed in section 6).
Slovenian: • ste alergični na trastuzumab, murine (mišje) beljakovine ali katero koli sestavino tega zdravila
English: Malignant neoplasm progression Not known Neoplasm progression
Slovenian: napredovanje maligne neoplazme neznano napredovanje neoplazme neznano
English: • shock
Slovenian: • šok
English: Time to disease progression, Median months
Slovenian: Čas do napredovanja bolezni, mediana (meseci)
English: * Observed with combination therapy following anthracyclines and combined with taxanes.
Slovenian: * Opaženo pri kombinirani uporabi po antraciklinih in sočasno s taksani.
English: • intravenous 5-fluorouracil - 800 mg/m2/day as a continuous intravenous infusion over 5 days,
Slovenian: ali - 5-fluorouracil intravensko - 800 mg/m2/dan v obliki kontinuirane intravenske infuzije 5 dni,
English: If LVEF percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks.
Slovenian: Če odstotek LVEF pade za ≥ 10 točk od začetne vrednosti IN pod 50 %, zdravljenje prekinemo in ponovno opravimo meritev LVEF v približno treh tednih.
English: Each carton contains 1 vial of powder.
Slovenian: Ena škatla vsebuje 1 vialo s praškom.
English: Docetaxel3 N = 94
Slovenian: docetaksel3 n = 94
English: EBC is defined as non-metastatic primary invasive carcinoma of the breast.
Slovenian: Zgodnji rak dojk je definiran kot nemetastatski, primarni, invazivni karcinom dojk.
English: Trastuzumab binds with high affinity and specificity to sub-domain IV, a juxta-membrane region of HER2's extracellular domain.
Slovenian: Trastuzumab se z visoko afiniteto in specifičnostjo veže na poddomeno IV, jukstamembransko regijo zunajcelične domene HER2.
English: What KANJINTI is and what it is used for What you need to know before you are given KANJINTI How KANJINTI is given
Slovenian: Kaj je zdravilo KANJINTI in za kaj ga uporabljamo Kaj morate vedeti, preden boste prejeli zdravilo KANJINTI Kako uporabljati zdravilo KANJINTI Možni neželeni učinki
English: • acute accumulation of fluid in the lungs
Slovenian: • akutno nabiranje tekočine v pljučih
English: Neoadjuvant-adjuvant treatment
Slovenian: Neoadjuvantno-adjuvantno zdravljenje
English: These are very common (may affect more than 1 in 10 people).
Slovenian: Ti so zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov).
English: There are no immunogenicity data available for trastuzumab in gastric cancer.
Slovenian: Za uporabo trastuzumaba pri raku želodca ni na voljo podatkov o imunogenosti.
English: Studies of HER2-positivity rates in gastric cancer (GC) using immunohistochemistry (IHC) and fluorescence in situ hybridisation (FISH) or chromogenic in situ hybridisation (CISH) have shown that there is a broad variation of HER2-positivity ranging from 6.8% to 34.0% for IHC and 7.1% to 42.6% for FISH.
Slovenian: Študije stopnje HER2-pozitivnosti pri raku želodca s pomočjo imunohistokemije (IHC) in fluorescenčne hibridizacije in situ (FISH) ali kromogene hibridizacije in situ (CISH) so pokazale veliko variabilnost HER2-pozitivnosti - od 6,8 % do 34,0 % za metodo IHC in 7,1 % do 42,6 % za metodo FISH.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after reconstitution and dilution.
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA Za intravensko uporabo po rekonstituciji in razredčitvi.
English: No long-term animal studies have been performed to establish the carcinogenic potential of trastuzumab, or to determine its effects on fertility in males.
Slovenian: Za ugotovitev kancerogenega potenciala trastuzumaba ali učinkov na plodnost pri moških niso opravili nobenih dolgotrajnih študij na živalih.
English: Occasionally, symptoms start later than six hours after the infusion begins.
Slovenian: Občasno se lahko simptomi pojavijo po več kot šestih urah po pričetku infuzije.
English: IHC is recommended as the first testing modality and in cases where HER2 gene amplification status is also required, either a silver-enhanced in situ hybridisation (SISH) or a FISH technique must be applied.
Slovenian: Kot prva metoda je priporočena imunohistokemijska metoda, v primerih, ko pa je potreben tudi status amplifikacije gena HER2, pa je treba uporabiti tehniko hibridizacije in situ s srebrom (SISH) ali FISH.
English: If the patient has missed a dose of KANJINTI by more than one week, a re-loading dose of KANJINTI should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible.
Slovenian: Če je bolnik izpustil odmerek zdravila KANJINTI za več kot en teden, mu je treba čim prej ponovno dati polnitveni odmerek zdravila KANJINTI v približno 90 minutah (tedenski režim: 4 mg/kg; 3-tedenski režim: 8 mg/kg).
English: This translates into an absolute benefit in terms of an 8 year disease-free survival rate of 6.4 percentage points in favour of 1 year trastuzumab treatment.
Slovenian: To se izraža kot absolutna korist enoletnega zdravljenja s trastuzumabom v smislu 8-letnega preživetja brez bolezni za 6,4 odstotne točke.
English: Trastuzumab is designed to bind selectively to an antigen called human epidermal growth factor receptor 2 (HER2).
Slovenian: Trastuzumab je oblikovan tako, da se selektivno veže na antigen, ki se imenuje humani receptor za epidermalni rastni dejavnik 2 (HER2).
English: It is also used in combination with medicines called aromatase inhibitors with patients with high levels of HER2 and hormone-receptor positive metastatic breast cancer (cancer that is sensitive to the presence of female sex hormones).
Slovenian: Uporablja se tudi v kombinaciji z zdravili, imenovanimi zaviralci aromataze, za zdravljenje bolnikov z metastatsko obliko raka dojk z velikimi količinami HER2 in pozitivnimi hormonskimi receptorji (to pomeni, da je tumor občutljiv na prisotnost ženskih spolnih hormonov);
English: Do not use this medicine after the expiry date which is stated on the outer carton and on the vial label after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in na nalepki na viali poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: If you experience any of the above symptoms when your treatment with KANJINTI has finished, you should see your doctor and tell them that you have previously been treated with KANJINTI.
Slovenian: Če se kateri koli izmed zgornjih simptomov pojavi po končanem zdravljenju z zdravilom KANJINTI, obiščite zdravnika in ga obvestite o tem, da ste se zdravili z zdravilom KANJINTI.
English: Some of the side effects you experience may be due to your underlying cancer.
Slovenian: Vzrok nekaterim neželenim učinkom, ki jih opazite, je lahko vaša bolezen - rak.
English: • you have ever had any other treatment for cancer.
Slovenian: • ste se že zdravili zaradi raka.
English: MBC and EBC patients had similar PK parameters (e.g. clearance (CL), the central compartment volume (Vc)) and population-predicted steady-state exposures (Cmin, Cmax and AUC).
Slovenian: Bolniki z MBC in EBC so imeli podobne farmakokinetične parametre (npr. očistek, volumen centralnega prostora (Vc)) in izpostavljenosti v stanju dinamičnega ravnovesja (Cmin, Cmax in AUC), predvidene za populacijo.
English: Pharmacokinetic data from Study H4613g/GO01305 suggested that carboplatin had no impact on the PK of trastuzumab.
Slovenian: Farmakokinetični podatki iz študije H4613g/GO01305 so nakazali, da karboplatin ni imel vpliva na farmakokinetiko trastuzumaba.
English: As animal reproduction studies are not always predictive of human response, KANJINTI should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus.
Slovenian: Izsledki študij o vplivu na sposobnost za razmnoževanje pri živalih ne veljajo vedno tudi za ljudi, zato se moramo uporabi zdravila KANJINTI med nosečnostjo izogibati, razen v primerih, ko pričakovana korist za mater upravičuje tveganje za plod.
English: Trastuzumab was administered weekly with chemotherapy and 3-weekly thereafter for a total of 52 weeks.
Slovenian: Trastuzumab so dajali tedensko s kemoterapijo, nato pa vsake 3 tedne, skupaj 52 tednov.
English: In 3 pivotal clinical trials of adjuvant trastuzumab given in combination with chemotherapy, the incidence of grade 3/4 cardiac dysfunction (specifically symptomatic congestive heart failure) was similar in patients who were administered chemotherapy alone (i.e. did not receive trastuzumab) and in patients who were administered trastuzumab sequentially to a taxane (0.3-0.4%).
Slovenian: V treh ključnih kliničnih preskušanjih pri adjuvantnem zdravljenju s trastuzumabom v kombinaciji s kemoterapijo je bila incidenca motenj v delovanju srca stopnje 3/4 (še posebno simptomatskega kongestivnega srčnega popuščanja) podobna pri bolnikih, ki so prejeli le kemoterapijo (to je, da niso prejeli trastuzumaba), in pri bolnikih, ki so prejeli trastuzumab zaporedno po taksanu (0,3 do 0,4 %).
English: Use of other reconstitution solvents should be avoided.
Slovenian: Uporaba drugih topil za rekonstitucijo ni dovoljena.
English: From a microbiological point of view, the reconstituted solution and KANJINTI infusion solution should be used immediately.
Slovenian: Z mikrobiološkega stališča je rekonstituirano raztopino in zdravilo KANJINTI raztopino za infundiranje treba uporabiti takoj.
English: Heart checks
Slovenian: Pregledi srca
English: If you have metastatic gastric cancer
Slovenian: Če imate metastatski rak želodca
English: In study BCIRG 006, 213/1075 patients in the DCarbH (TCH) arm, 221/1074 patients in the AC→DH (AC→TH) arm, and 217/1073 in the AC→D (AC→T) arm had a Karnofsky performance status ≤ 90 (either 80 or 90).
Slovenian: V študiji BCIRG 006 je 213/1075 bolnikov v skupini DCarbH (TCH), 221/1074 bolnikov v skupini AC → DH (AC → TH) in 217/1073 bolnikov v skupini AC → D (AC → T) imelo stanje zmogljivosti po Karnofskem ≤ 90 (ali 80 ali 90).
English: Do not freeze the reconstituted solution.
Slovenian: Rekonstituirane raztopine ne zamrzujte.
English: Aseptic handling must be ensured when preparing the infusion.
Slovenian: Pri pripravi infuzije je treba zagotoviti aseptično ravnanje:
English: The administration of concomitant anastrozole did not appear to influence the pharmacokinetics of trastuzumab.
Slovenian: Sočasno dajanje anastrazola ni imelo vpliva na farmakokinetiko trastuzumaba.
English: • abnormal development of the kidneys of the baby in the womb
Slovenian: • nenormalen razvoj ledvic otroka v maternici
English: KANJINTI may be prescribed in combination with the chemotherapy medicine paclitaxel or docetaxel as first treatment for metastatic breast cancer or it may be prescribed alone if other treatments have proved unsuccessful.
Slovenian: Zdravilo KANJINTI se lahko predpiše v kombinaciji s citostatikoma paklitakselom ali docetakselom kot prvo zdravljenje metastatskega raka dojk ali pa se uporablja samostojno, če so bile ostale oblike zdravljenja neuspešne.
English: As a result, trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumour cells that overexpress HER2.
Slovenian: Posledično je trastuzumab tako v in vitro študijah kot tudi pri živalih zaviral delitev človeških tumorskih celic, ki čezmerno izražajo HER2.
English: Patients who receive anthracyclines after stopping KANJINTI may possibly be at increased risk of cardiac dysfunction.
Slovenian: Pri bolnikih, ki prejemajo antracikline po prenehanju zdravljenja z zdravilom KANJINTI, lahko obstaja večje tveganje za motnje v delovanju srca.
English: In general, FISH is considered positive if the ratio of the HER2 gene copy number per tumour cell to the chromosome 17 copy number is greater than or equal to 2, or if there are more than 4 copies of the HER2 gene per tumour cell if no chromosome 17 control is used.
Slovenian: V splošnem velja, da je rezultat metode FISH pozitiven, če je razmerje med številom kopij gena HER2 na tumorsko celico in številom kopij kromosoma 17 večje ali enako 2, ali če je število kopij gena HER2 na tumorsko celico večje od 4, če ne uporabimo preverjanja s kromosomom 17.
English: This investigative clinical trial assay performed in a central laboratory utilised a 0 to 3+ scale.
Slovenian: Preiskovalno metodo so zaradi kliničnega preskušanja izvajali v centralnem laboratoriju in za vrednotenje rezultatov uporabili lestvico od 0 do 3+.
English: The study recruited patients with newly diagnosed locally advanced (Stage III) or inflammatory EBC.
Slovenian: V študijo so vključili bolnike z novo diagnosticiranim lokalno napredovalim rakom dojk (stadij III) ali z zgodnjo obliko vnetnega raka dojk.
English: Binding of trastuzumab to HER2 inhibits ligand-independent HER2 signalling and prevents the proteolytic cleavage of its extracellular domain, an activation mechanism of HER2.
Slovenian: Vezava trastuzumaba na HER2 zavira od liganda neodvisno signalno pot HER2 in preprečuje proteolitično cepitev zunajcelične domene, ki predstavlja aktivacijski mehanizem HER2.