Abiraterone Acetate in Molecular Apocrine Breast Cancer

• Status: Completed
• Trial end date: 2018-07-04
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to estimate antitumour activity of abiraterone acetate in Patients with a Molecular Apocrine HER2-negative locally advanced or metastatic Breast Cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNICANCER
• Treatments: Abiraterone Acetate; Prednisone

Criteria

Inclusion Criteria:

• Women aged ≥18 years;

• Histologically confirmed locally advanced or metastatic breast cancer;

• Triple negative breast cancer:

Estrogen receptor (ER)-negative and Progesterone receptor (PR)-negative, as defined by a <10 % tumour stained cells by immunohistochemistry (IHC); HER2 negative status (i.e. IHC score 0 or 1+, or IHC score 2+ and FISH/SISH/CISH negative), confirmed centrally before inclusion with FFPE tissue from either primary or metastatic breast cancer site*;

• Androgen receptor (AR)-positive, as defined centrally by a ≥10% tumour stained cells by IHC (AR assessment by local pathologist before inclusion is not mandatory);

• Patients could be chemotherapy naïve (provided they are not presenting with life-threatening metastasis) or have received any number of previous lines of chemotherapy (providing their life expectancy is ≥3 months);

• Pre and post menopausal patients are eligible.

• Measurable or non measurable disease according to RECIST v1.1 criteria;

• PS (ECOG) ≤2;

• Normal haematological function: ANC ≥1,500/mm3; platelets count ≥100,000/mm3; haemoglobin >10 g/dl;

• 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);

• Creatinine clearance (MDRD formula) ≥50 mL/min OR creatinine ≤1.5 times ULN;

• Normal kalemia (serum potassium ≥3.5 mM), natremia and magnesemia;

• Systolic blood pressure (BP) <160 mm Hg and diastolic BP <95 mm Hg, as documented on inclusion day (Hypertension at baseline assessment allowed provided it is currently controlled under anti-hypertensive drugs);

• Cardiac ejection fraction ≥50% measured by MUGA or ECHO done within 4 weeks before inclusion;

• If receiving a bisphosphonate or denosumab, dose must have been stable for at least 2 doses before inclusion;

• Patient agreeing to use effective contraception during and for ≥ 6 months after completion of study treatment;

• Patient able to comply with the protocol;

• Patient must have signed a written informed consent form prior to any study specific procedures;

• Patient must be affiliated to a Social Health Insurance.

Exclusion Criteria:

• Male breast cancer;

• HER2-positive status (positivity defined as IHC3+ and/or FISH amplification >2.2);

• 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;

• 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;

• Non-malignant systemic disease, including active infection or concurrent serious illness that would make the patient a high medical risk;

• Significant cardiovascular disease, including any of the following:

1. NYHA class III-IV congestive heart failure;

2. Unstable angina pectoris or myocardial infarction within the past 6 months;

3. Severe valvular heart disease;

4. Ventricular arrhythmia requiring treatment.

• Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not be included;

• Patients with known allergies, hypersensitivity or intolerance to abiraterone acetate, prednisone, or their excipients;

• Persistent toxicities ≥ grade 2 from any cause, except chemotherapy-induced alopecia and Grade 2 peripheral neuropathy;

• Active or uncontrolled autoimmune disease requiring concurrent corticosteroid therapy;

• Any gastrointestinal disorder interfering with absorption of the study drug;

• Difficulties with swallowing study capsules;

• 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;

• Concurrent enrolment in another clinical trial in which investigational therapies are administered;

• Pregnant women, women who are likely to become pregnant or are breast-feeding;

• 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;

• Patients with history of non compliance to medical regimens or unwilling or unable to comply with the protocol;

• Individual deprived of liberty or placed under the authority of a tutor.