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Multicenter, Randomized, Phase II Study of Neoadjuvant Chemotherapy Associated or Not With Zoledronate and Atorvastatin in Triple Negative Breast Cancers - YAPPETIZER Study

Studio Clinico

Patologia: Neoplasie della mammella

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: 

Fase di studio: II Randomizzato

Linee di trattamento: Adiuvante/neoadiuvante

Criteri di inclusione: 

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 and RNA-Seq molecular determinations
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

Criteri di esclusione: 

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
7. Co-existing active infection or concurrent illness that, at the judgment of the investigator, contra-indicate the inclusion of the patient in the study
8. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal
9. Co-existing dental diseases that form a contraindication to the use of zol
10. Any medical or other condition that in the Investigator's opinion renders the patient unsuitable for this study due to unacceptable risk
11. Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures
12. Known hypersensitivity to the active substance, to other bisphosphonates or to any excipients of zoledronate
13. Known hypersensitivity to the active substance or to any excipients of atorvastatin. Conditions of rare hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
14. Anticipation of need for major surgical procedure during the course of the trial
15. Pregnant or breast feeding women.

Trattamento sperimentale: 

standard NACT + Zol + atorvastatin

Trattamento di controllo: 

standard NACT

Obiettivi primari dello studio: 

1. Proof of concept primary activity endpoint - Efficacy endpoint [ Time Frame: At surgery, after 6 months of study treatment ]
Relative reductions of YAP and TAZ IHC-expression at surgery with respect to core-biopsy analysis.

2. The proportion of responded patients [ Time Frame: After 6 months of study treatment ]
The clinical primary activity endpoint of the second phase of study is the proportion of responder patients, defined as those obtaining a pCR, defined as ypT0ypN0 or as the absence of any residual tumor burden at surgery.

Centri partecipanti

Nord Italia

Ospedale Papa Giovanni XXIII Bergamo
Piazza OMS 1 - 24127 Bergamo - BG

Riferimento: Dr. Alberto Zambelli
Telefono: 0352673694
Email: alberto.zambelli@asst-pg23.it

 

A.O. S. Anna di Como
Via Ravona 8 - 22040 San Fermo della Battaglia - CO

Riferimento: Dr.ssa Monica Giordano
Email: monica.giordano@asst-lariana.it

 

A.O. San Gerardo
Via Pergolesi 33 - 20900 Monza - MB

Riferimento: Dr.ssa Marina Cazzaniga
Email: marina.cazzaniga@asst-monza.it

 

Centro Italia

Istituto Nazionale Tumori “Regina Elena”
Via Elio Chianesi 53 - 00144 Roma - RM

Riferimento: Dr.ssa Alessandra Fabi
Email: alessandra.fabi@ifo.gov.it

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2016-005112-17

Data di inserimento: 04.06.2019

Promotore

IRCCS Istituto di Ricerche Farmacologiche Mario Negri, Milano

CRO

NA

Principal Investigator ITALIA

ASST Papa Giovanni XXIII, Bergamo

Riferimento: Dr. Alberto Zambelli

Telefono: 0352673694

Email: alberto.zambelli@asst-pg23.it

Localita: Bergamo

 

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