Clinical study aimed to assess in patients with triple-negative operable breast cancer the activity of the drug zoledronate administered before surgery, according to the the tumor aggressiveness (determined by the level of expression of the p53 protein)
- Conditions
- ewly diagnosed, untreated, operable triple negative breast cancerMedDRA version: 18.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-004194-16-IT
- Lead Sponsor
- IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 21
Patients with newly diagnosed, untreated, operable triple negative breast cancer (TNBC), intended to definitive breast surgery and suitable for pre-operative therapy with zol.
Patients must meet all the following criteria for study entry:
- Histologically confirmed diagnosis of non-metastatic operable TNBC subjected to diagnostic core biopsy
- TNBC defined as HER2/ER/PgR negative receptors
- Age = 18 years old
- ECOG (Eastern Cooperative Oncology Group) performance status = 1
- Ki67 and p53 expression determined by IHC
- Availability of paraffin-embedded tumor block (FFPE) taken at diagnostic biopsy for IHC and RT-PCR molecular determinations
- Female patients with reproductive potential must have a negative serum pregnancy test within 7 days prior to start of trial. Both women and men must agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months (female patients) and 6 months (male patients) after discontinuation of treatment.
- 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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 18
Patients who meet any of the following criteria will be excluded from study entry:
- Presence of metastatic disease
- Clinical indication of debulking neo-adjuvant treatment
- Previous investigational treatment for any condition within four weeks prior to study registration
-Treatment with bisphosphonates, denosumab or other drug that, in the Investigator’s judgment, affects bone metabolism
-Treatment with statins or other drugs that, in the Investigator’s judgment, potentially affect the mevalonate pathway
- Any previous treatment for the currently diagnosed breast cancer, including radiation therapy, chemotherapy, biotherapy and/or hormonal therapy
- Inadequate bone marrow, hepatic or renal function including the following:
•Hb< 9.0 g/dL, absolute neutrophil count < 1.5 x 109/L, platelets <100 x 109/L
•Total bilirubin > 1.5 x ULN, excluding cases where elevated bilirubin can be attributed to Gilberts Syndrome
•AST (SGOT), ALT (SGPT) > 2.5 x ULN
•Creatinine > 1.2 x ULN, calcium < 8.6 mg/dL
- Co-existing active infection or concurrent illness that, at the judgment of the investigator, contra-indicate the inclusion of the patient in the study
- Co-existing dental diseases that form a contraindication to the use of zol
- Any medical or other condition that in the Investigator’s opinion renders the patient unsuitable for this study due to unacceptable risk
- Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary study assessment and procedures
- Known hypersensitivity to any excipients of zoledronate
- Anticipation of need for major surgical procedure during the course of the trial
- 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