Molecular apocrine locally advanced or metastatic breast cancer MedDRA version: 14.1 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
UNICANCER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Women aged = 18 years, 2) Histologically confirmed locally advanced or metastatic breast cancer, 3) Triple negative breast cancer: Estrogen receptor (ER)-negative and Progesteron receptor (PR)-negative, as defined by a 10 g/dl, 10) Normal hepatic function: total bilirubin = 1.5 upper normal limit (UNL); ASAT and ALAT = 2.5 UNL (= 5 UNL in the presence of liver metastases), 11) Creatinine clearance (MDRD formula) = 50 mL/min OR creatinine = 1.5 times ULN, 12) Normal kalemia (serum potassium = 3.5mM), natremia and magnesaemia, 13) Systolic blood pressure (BP) =65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: 1) Male breast cancer, 2) HER2-positive status (positivity defined as IHC3+ and/or FISH amplification >2.2), 3) Other concurrent malignancies, except adequately treated cone-biopsied in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin; patients who have undergone potentially curative therapy for a prior malignancy are eligible provided there is no evidence of disease for = 5 years and patient is deemed to be at low risk for recurrence, 4) Active brain metastases or leptomeningeal disease; History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain, 5) Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk, 6) Significant cardiovascular disease, including any of the following: a) NYHA class III-IV congestive heart failure b) Unstable angina pectoris or myocardial infarction within the past 6 months c) Severe valvular heart disease d) Ventricular arrhythmia requiring treatment, 7) Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included, 8) Persistent toxicities = grade 2 from any cause, except chemotherapy-induced alopecia and Grade 2 peripheral neuropathy, 9) Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy, 10) Any gastrointestinal disorder interfering with absorption of the study drug, 11) Difficulties with swallowing study capsules, 12) Prior anticancer therapy, including radiotherapy, endocrine therapy, immunotherapy, chemotherapy (CT) within the last 3 weeks (2 weeks for oral or weekly CT ; 6 weeks for nitrosoureas and mitomycin C), or other investigational agents ; Concurrent palliative radiotherapy allowed, 13) Concurrent enrolment in another clinical trial in which investigational therapies are administered, 14) Pregnant women, women who are likely to become pregnant or are breast-feeding, 15) Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial, 16) Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol, 17) Individual deprived of liberty or placed under the authority of a tutor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate antitumor activity of abiraterone acetate, as measured by the 6 months clinical benefit rate (CBR) in molecular apocrine HER2-negative locally advanced or metastatic breast cancer.;Secondary Objective: - Objective response rate (ORR) - Duration of overall response (DoR). - Overall survival (OS) - Progression-free survival (PFS) - Tolerance and safety of abiraterone acetate. ;Primary end point(s): Clinical benefit rate (CBR) : The 6-months CBR is the measurement of all patients who have a complete response (CR), partial response (PR) or stable disease (SD), according to RECIST criteria v1.1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: - Objective response rate (ORR) The Objective response is defined as complete response (CR) or partial response (PR) according to RECIST criteria v1.1. - Duration of overall response (DoR) The DoR is defined as the time from documentation of tumour response (CR/PR) to disease progression, according to RECIST criteria v1.1. - Overall Survival (OS) The OS is defined as the time from the first administration of abiraterone acetate to death from any cause. - Progression-free survival (PFS) The PFS is defined as the time from the first administration of abiraterone acetate to progression (or death of any cause, whichever occurs first Safety: - Evaluation of Toxicity Safety will be evaluated by type, frequency and severity of adverse drug reactions according to NCI-CTC (v4.0): In order to be considered evaluable for toxicity, patients should have received at least one dose of treatment. | — |
Countries
France
Contacts
Public ContactChristine ORSINI
UNICANCER
Outcome results
None listed