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A double-blind, placebo-controlled, randomized phase III study of ipatasertib in combination with paclitaxel as a treatment for patients with pik3ca/akt1/pten-altered, locally advanced or metastatic, triple-negative breast cancer or hormone receptor–positive, HER2-negative breast cancer - CO40016

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: III

Richiesta mandatoria di tessuto: 

Linee di trattamento: Prima linea

Criteri di inclusione: 

• Women or men aged =>18 years with histologically documented triple-negative breast cancer (TNBC) or HR+/HER2- adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to resection with curative intent
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
• Adequate hematologic and organ function within 14 days prior to treatment initiation
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
• Consent to submit a formalin-fixed, paraffin-embedded tumor (FFPE) tissue block or freshly cut unstained, serial tumor slides from the most recently collected tumor tissue for central molecular analysis:
• Valid results from central molecular analysis confirming PIK3CA/AKT1/PTEN-altered status in tumor tissue by next-generation sequencing (NGS)

Criteri di esclusione: 

• Treatment with approved or investigational cancer therapy within 14 days prior to treatment initiation
• Any previous chemotherapy for inoperable locally advanced or metastatic TNBC or HR+/HER2- adenocarcinoma of the breast
• Participants with HR+/HER2- breast cancer for whom endocrine-based therapy is considered an appropriate option per local clinical guidelines (i.e. participants should not be considered eligible for endocrine-based treatment)
• History of or known presence of brain or spinal cord metastases
• Malignancies other than breast cancer within 5 years prior to treatment initiation (except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer)
• Prior treatment with an Akt inhibitor (prior PI3K or mTOR inhibitors are allowed)
• History of malabsorption syndrome or other condition that would interfere with enteral absorption or results in the inability or unwillingness to swallow pills
• Active infection requiring antibiotics
• Known human immunodeficiency virus (HIV) infection
• Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, including active viral or other hepatitis, current drug or alcohol abuse, or cirrhosis
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to initiation of treatment (or anticipated need during study)
• Pregnant or breastfeeding, or intending to become pregnant during the study
• Clinically significant cardiac dysfunction (including NYHA Class II/III/IV heart failure, left ventricular ejection fraction [LVEF] <50%, active ventricular arrhythmia requiring medication, history of myocardial infarction within 6 months of treatment initiation, clinically significant electrocardiogram [ECG] abnormalities).
• Need for chronic corticosteroid therapy of >=10 mg of prednisone per day or an equivalent dose of other anti-inflammatory corticosteroids or immunosuppressants for a chronic disease
• Unresolved, clinically significant toxicity from prior therapy
• Uncontrolled clinical symptoms including pleural effusion, pericardial effusion, or ascites, tumor-related pain, hypercalcemia (or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy)
• History of Type I or Type II diabetes mellitus requiring insulin
• Grade >=2 uncontrolled or untreated hypercholesterolemia or hypertriglyceridemia
• History of or active inflammatory bowel disease or active bowel inflammation
• Clinically significant lung disease (including pneumonitis, interstitial lung disease, idiopathic pulmonary fibrosis, cystic fibrosis, active infection/ history of opportunistic infections)
• Treatment with strong CYP3A inhibitors or strong CYP3A inducers within 2 weeks or 5 drug-elimination half-lives, whichever is longer, prior to initiation of treatment
• Grade >=2 peripheral neuropathy

 

Trattamento sperimentale: 

ipatasertib + paclitaxel

Trattamento di controllo: 

placebo + paclitaxel

Obiettivi primari dello studio: 

To evaluate the efficacy of ipatasertib + paclitaxel compared with placebo + paclitaxel

Obiettivi secondari dello studio: 

- To evaluate the efficacy of ipatasertib + paclitaxel compared with placebo + paclitaxel

- To evaluate PROs of GHS/HRQoL associated with ipatasertib + paclitaxel compared with placebo + paclitaxel

Centri partecipanti

Nord Italia

Ospedale S.Orsola Malpighi, Università di Bologna
Via Pietro Albertoni 15 - 40138 Bologna - BO
UO Oncologia Medica

Riferimento: Dr. Claudio Zamagni
Telefono: 0512144548
Email: claudio.zamagni@aosp.bo.it

 

Istituto Oncologico Veneto IRCCS
Via Gattamelata 64 - 35128 Padova - PD
Oncologia Medica II

Riferimento: Prof. Pierfranco Conte
Telefono: 0498215290
Email: pierfranco.conte@unipd.it

 

Centro di Riferimento Oncologico
Via Franco Gallini 2 - 33081 Aviano - PN
Dipartimento di Oncologia Medica

Riferimento: Dr. Simon Spazzapan
Telefono: 0434659725
Email: spazzapan@cro.it

 

Centro Italia

Ospedale Santa Maria Annunziata AUSL 10
Via dell'Antella 58 - 50012 Bagno a Ripoli - FI
Oncologia

Riferimento: Dr.ssa Francesca Martella
Telefono: 0556936697
Email: francesca.martella@uslcentro.toscana.it

 

Sud Italia e isole

Istituto Nazionale Tumori IRCCS Fondazione Pascale
Via Mariano Semmola - 80131 Napoli - NA
UOC Oncologia Medica Senologica

Riferimento: Dr. Michelino De Laurentiis
Telefono: 0815903559
Email: m.delaurentiis@istitutotumori.mi.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2017-001548-36

Data di inserimento: 28.03.2018

Data di aggiornamento: 27.06.2019

Promotore

F. Hoffmann-La Roche Ltd

CRO

NA

Principal Investigator ITALIA

Istituto Nazionale dei Tumori - IRCCS Fondazione Pascale, Napoli

Riferimento: Dr. Michelino De Laurentiis

Telefono: 0815903559

Email: m.delaurentiis@istitutotumori.mi.it

Localita: Napoli

 

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