Pre-operative chemotherapy associated or not with zoledronate and atorvastatin in patients with triple negative breast cancer - YAPPETIZER Study
- Conditions
- Triple Negative Breast CancerMedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-005112-17-IT
- Lead Sponsor
- IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 154
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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method