Multicenter, randomized, phase II study of neoadjuvant chemotherapy associated or not with zoledronate and atorvastatin in triple negative breast cancers - YAPPETIZER Study - YAPPETIZER

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 sites154 target enrollmentJune 8, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 8, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

•1\.Histologically confirmed diagnosis of non\-metastatic operable TNBC subjected to diagnostic core biopsy
•2\.TNBC defined as HER2/ER/PgR negative receptors
•3\.Female, aged \= 18 years
•4\.ECOG (Eastern Cooperative Oncology Group) performance status \= 1
•5\.Clinical indication for a neoadjuvant approach according to the investigator‘s judgment. The standard chemotherapy will consist of a complete pre\-operative treatment with anthracyclines and taxanes (in sequence or combination), including platinum derivatives and dose\-dense schedules, according to the best physician choice (BPC)
•6\.Availability of paraffin\-embedded tumor block (FFPE) taken at diagnostic biopsy for IHC
•7\.Patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to study entry. They must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months after discontinuation of treatment
•8\.Written informed consent signed prior to enrolment according to ICH/GCP.
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•1\.Presence of metastatic disease
•2\.Previous investigational treatment for any condition within four weeks prior to study registration
•3\.Treatment with bisphosphonates, denosumab or other drug that, in the investigator’s judgment, affects bone metabolism
•4\.Treatment with statins or other drugs that, in the investigator’s judgment, potentially affect the mevalonate pathway
•5\.Any previous treatment for the currently diagnosed breast cancer, including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy
•6\.Inadequate bone marrow, hepatic or renal function including the following:
•a.Hb\< 9\.0 g/dL, absolute neutrophil count \< 1\.5 x 109/L, platelets \<100 x 109/L
•b.Total bilirubin \> 1\.5 x ULN, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
•c.AST (SGOT), ALT (SGPT) \> 2\.5 x ULN
•d.Creatinine \> 1\.2 x ULN, calcium \< 8\.6 mg/dL