• Je něco špatně v tomto záznamu ?

A randomized, placebo-controlled phase 2 study of paclitaxel in combination with reparixin compared to paclitaxel alone as front-line therapy for metastatic triple-negative breast cancer (fRida)

LJ. Goldstein, M. Mansutti, C. Levy, JC. Chang, S. Henry, I. Fernandez-Perez, J. Prausovà, E. Staroslawska, G. Viale, B. Butler, S. McCanna, PA. Ruffini, MS. Wicha, AF. Schott, fRida Trial Investigators

. 2021 ; 190 (2) : 265-275. [pub] 20210903

Jazyk angličtina Země Nizozemsko

Typ dokumentu klinické zkoušky, fáze II, časopisecké články, randomizované kontrolované studie

Perzistentní odkaz   https://www.medvik.cz/link/bmc22003275

Grantová podpora
P30 CA006927 NCI NIH HHS - United States

E-zdroje Online Plný text

NLK ProQuest Central od 1997-01-01 do Před 1 rokem
Medline Complete (EBSCOhost) od 2005-01-01 do Před 1 rokem
Health & Medicine (ProQuest) od 1997-01-01 do Před 1 rokem
Family Health Database (ProQuest) od 1997-01-01 do Před 1 rokem
Public Health Database (ProQuest) od 1997-01-01 do Před 1 rokem

Odkazy

PubMed 34476645
DOI 10.1007/s10549-021-06367-5
Knihovny.cz E-zdroje

PURPOSE: CXCR1, one of the receptors for CXCL8, has been identified as a druggable target on breast cancer cancer stem cells (CSC). Reparixin (R), an investigational oral inhibitor of CXCR1, was safely administered to metastatic breast cancer patients in combination with paclitaxel (P) and appeared to reduce CSC in a window-of-opportunity trial in operable breast cancer. The fRida trial (NCT02370238) evaluated the addition of R to weekly as first-line therapy for metastatic (m) TNBC. SUBJECTS AND METHODS: Subjects with untreated mTNBC were randomized 1:1 to R or placebo days 1-21 in combination with weekly P 80 mg/m2 on days 1, 8, 15 of 28-day cycles. The primary endpoint was PFS by central review. RESULTS: 123 subjects were randomized (62 to R + P and 61 to placebo + P). PFS was not different between the 2 groups (median 5.5 and 5.6 months for R + P and placebo + P, respectively; HR 1.13, p = 0.5996). ALDH+ and CD24-/CD44+ CSC centrally evaluated by IHC were found in 16 and 34 of the 54 subjects who provided a metastatic tissue biopsy at study entry. Serious adverse events (21.3 and 20% of subjects) and grade ≥ 3 adverse reactions (ADR) (9.1 and 6.3% of all ADRs) occurred at similar frequency in both groups. CONCLUSION: fRida is the first randomized, double-blind clinical trial of a CSC-targeting agent in combination with chemotherapy in breast cancer. The primary endpoint of prolonged PFS was not met. CLINICAL TRIAL REGISTRATION/DATE OF REGISTRATION: NCT01861054/February 24, 2015.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc22003275
003      
CZ-PrNML
005      
20220127150510.0
007      
ta
008      
220113s2021 ne f 000 0|eng||
009      
AR
024    7_
$a 10.1007/s10549-021-06367-5 $2 doi
035    __
$a (PubMed)34476645
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a ne
100    1_
$a Goldstein, Lori J $u Department of Medical Oncology, Fox Chase Cancer Center, 333 Cottman Ave, Philadelphia, PA, 19111, USA. Lori.Goldstein@fccc.edu
245    12
$a A randomized, placebo-controlled phase 2 study of paclitaxel in combination with reparixin compared to paclitaxel alone as front-line therapy for metastatic triple-negative breast cancer (fRida) / $c LJ. Goldstein, M. Mansutti, C. Levy, JC. Chang, S. Henry, I. Fernandez-Perez, J. Prausovà, E. Staroslawska, G. Viale, B. Butler, S. McCanna, PA. Ruffini, MS. Wicha, AF. Schott, fRida Trial Investigators
520    9_
$a PURPOSE: CXCR1, one of the receptors for CXCL8, has been identified as a druggable target on breast cancer cancer stem cells (CSC). Reparixin (R), an investigational oral inhibitor of CXCR1, was safely administered to metastatic breast cancer patients in combination with paclitaxel (P) and appeared to reduce CSC in a window-of-opportunity trial in operable breast cancer. The fRida trial (NCT02370238) evaluated the addition of R to weekly as first-line therapy for metastatic (m) TNBC. SUBJECTS AND METHODS: Subjects with untreated mTNBC were randomized 1:1 to R or placebo days 1-21 in combination with weekly P 80 mg/m2 on days 1, 8, 15 of 28-day cycles. The primary endpoint was PFS by central review. RESULTS: 123 subjects were randomized (62 to R + P and 61 to placebo + P). PFS was not different between the 2 groups (median 5.5 and 5.6 months for R + P and placebo + P, respectively; HR 1.13, p = 0.5996). ALDH+ and CD24-/CD44+ CSC centrally evaluated by IHC were found in 16 and 34 of the 54 subjects who provided a metastatic tissue biopsy at study entry. Serious adverse events (21.3 and 20% of subjects) and grade ≥ 3 adverse reactions (ADR) (9.1 and 6.3% of all ADRs) occurred at similar frequency in both groups. CONCLUSION: fRida is the first randomized, double-blind clinical trial of a CSC-targeting agent in combination with chemotherapy in breast cancer. The primary endpoint of prolonged PFS was not met. CLINICAL TRIAL REGISTRATION/DATE OF REGISTRATION: NCT01861054/February 24, 2015.
650    _2
$a protokoly protinádorové kombinované chemoterapie $x škodlivé účinky $7 D000971
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a lidé $7 D006801
650    _2
$a paclitaxel $x škodlivé účinky $7 D017239
650    _2
$a sulfonamidy $7 D013449
650    12
$a triple-negativní karcinom prsu $x farmakoterapie $7 D064726
655    _2
$a klinické zkoušky, fáze II $7 D017427
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
700    1_
$a Mansutti, Mauro $u Azienda Ospedaliero Universitaria Santa Maria della Misericordia, 33100, Udine, Italy
700    1_
$a Levy, Christelle $u CLCC Francois Baclesse, Caen, France
700    1_
$a Chang, Jenny C $u The Methodist Hospital Research Institute, Houston, Tx, 77030, USA
700    1_
$a Henry, Stephanie $u CHU UCL Namur, site Ste Elisabeth, Namur, Belgium
700    1_
$a Fernandez-Perez, Isaura $u Hospital Alvaro Cunqueiro, 36204, Vigo, Spain
700    1_
$a Prausovà, Jana $u Fakultni nemocnice v Motole, Onkologická klinika 2, LF UK a FN Motol, Praha, Czech Republic
700    1_
$a Staroslawska, Elzbieta $u Centrum Onkologii Ziemi Lubelskiej św. Jana z Dukli, Lublin, Poland
700    1_
$a Viale, Giuseppe $u IEO Istituto Europeo di Oncologia IRCCS, 20141, Milano, Italy $u University of Milan, Milano, Italy
700    1_
$a Butler, Beth $u Research and Development, Dompé farmaceutici s.p.a., 20122, Milano, Italy
700    1_
$a McCanna, Susan $u Research and Development, Dompé farmaceutici s.p.a., 20122, Milano, Italy
700    1_
$a Ruffini, Pier Adelchi $u Research and Development, Dompé farmaceutici s.p.a., 20122, Milano, Italy
700    1_
$a Wicha, Max S $u Rogel Cancer Center, University of Michigan, Ann Arbor, MI, 48109, USA
700    1_
$a Schott, Anne F $u Rogel Cancer Center, University of Michigan, Ann Arbor, MI, 48109, USA
710    2_
$a fRida Trial Investigators
773    0_
$w MED00009361 $t Breast cancer research and treatment $x 1573-7217 $g Roč. 190, č. 2 (2021), s. 265-275
856    41
$u https://pubmed.ncbi.nlm.nih.gov/34476645 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20220113 $b ABA008
991    __
$a 20220127150507 $b ABA008
999    __
$a ok $b bmc $g 1750899 $s 1154424
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2021 $b 190 $c 2 $d 265-275 $e 20210903 $i 1573-7217 $m Breast cancer research and treatment $n Breast Cancer Res Treat $x MED00009361
GRA    __
$a P30 CA006927 $p NCI NIH HHS $2 United States
LZP    __
$a Pubmed-20220113

Najít záznam

Citační ukazatele

    Možnosti archivace