A Phase II Trial Evaluating the Activity of Abiraterone Acetate Plus Prednisone in Patients With a Molecular Apocrine HER2-negative Locally Advanced or Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Abiraterone Acetate
- Conditions
- Breast Cancer
- Sponsor
- UNICANCER
- Enrollment
- 34
- Locations
- 36
- Primary Endpoint
- Clinical benefit rate (CBR)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Detailed Description
Screening : All women 18+, with a confirmed locally advanced or metastatic Triple Negative Breast Cancer (TNBC), will be screened and invited to participate (300-500 patients). Only patients with a centralized confirmation of ER-/PR-/HER2- and evaluation of AR+ will be included and treated with abiraterone acetate plus prednisone (31 patients). The Treatment phase comprises a series of 4 weeks-cycles with continuous study treatment. Study drug treatment will continue until the earliest of the following events: disease progression, unacceptable toxicity, or death. At disease progression, patients must be discontinued from study drug and should be evaluated within 30 days during the Post treatment visit and then entered into the Follow-Up phase.Patients should enter the Follow-Up Period regardless of reason for study drug discontinuation and should be monitored every 3 months (± 7 days) during 2 years.
Investigators
Eligibility 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;
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:
- •NYHA class III-IV congestive heart failure;
- •Unstable angina pectoris or myocardial infarction within the past 6 months;
- •Severe valvular heart disease;
- •Ventricular arrhythmia requiring treatment.
Arms & Interventions
Abiraterone Acetate
Intervention: Abiraterone Acetate
Outcomes
Primary Outcomes
Clinical benefit rate (CBR)
Time Frame: at 6 months
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. At six months, patients will be classified as success (Alive at 6 months AND CR/PR/ SD) or failure (dead OR alive with progression).
Secondary Outcomes
- Overall Survival (OS)(median follow-up = 2 years)
- Progression-free survival (PFS)(median follow-up = 2 years)
- Objective response rate (ORR)(at 6 months)
- Duration of overall response (DoR)(at 6 months)
- Overall safety profile(during the on-treatment period (defined as the period from the time of first dose of study medications up to 30 days of the last dose))