A Phase II study of olaparib in breast cancer patients: biological evaluation from a 'window of opportunity' trial.
The OLTRE trial (ClinicalTrials.gov number: NCT02681562) is an open-label, 'window of opportunity' Phase II controlled trial to evaluate the biological activity of olaparib in locally advanced triple-negative breast cancer compared with other subtypes of locally advanced breast cancer patients carrying germinal BRCA mutation receiving olaparib with the same treatment approach. The primary end point is to investigate the correlation between baseline gene and protein expression profile in order to identify possible predictive markers of response to olaparib. The OLTRE trial is expected to identify the surrogate markers of the biological activity of olaparib in the treatment of patients with triple-negative breast cancer.
Section of Pharmacology & University Center DIFF-Drug Innovation Forward Future, Department of Molecular & Translational Medicine, University of Brescia, Viale Europa 11, 25124 Brescia, Italy.|US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Giandomenico
G
Roviello
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Manuela
M
Milani
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Angela
A
Gobbi
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Martina
M
Dester
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Maria Rosa
MR
Cappelletti
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Giovanni
G
Allevi
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Sergio
S
Aguggini
Section of Experimental Oncology, Department of Clinical & Experimental Medicine, University of Parma, Via Università, 12, 43121 Parma, Italy.
Andrea
A
Ravelli
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Francesca
F
Gussago
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Alessandra
A
Cocconi
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Laura
L
Zanotti
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Chiara
C
Senti
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Carla
C
Strina
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.
Alberto
A
Bottini
US Terapia Molecolare e Farmacogenomica, ASST Cremona, Cremona, Italy.|Department of Medical, Surgery & Health Sciences, University of Trieste, Piazza Ospitale 1, 34129 Trieste, Italy.
Daniele
D
Generali
D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D058990:Molecular Targeted Therapy; D009367:Neoplasm Staging; D010793:Phthalazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010879:Piperazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000067856:Poly(ADP-ribose) Polymerase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D064726:Triple Negative Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy / Q000401:mortality
D000970:Antineoplastic Agents; D010793:Phthalazines; D010879:Piperazines; D000067856:Poly(ADP-ribose) Polymerase Inhibitors; C531550:olaparib
BRCA; olaparib; triple-negative breast cancer