A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
- Conditions
- Metastatic Breast CancerMedDRA version: 14.1Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2011-000621-80-PL
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 300
1. Woman >=18 years of age and postmenopausal determined by one of the following:
•bilateral, surgical oophorectomy
•age >=60 years
•age <60 years, with amenorrhea >=24 months and follicle-stimulating hormone and luteinizing hormone concentrations within postmenopausal range
2. Subjects with ER+, Her2- metastatic breast cancer, confirmed within 7 days before randomization with FFPE tissue from either primary or metastatic breast cancer site. In a subject with multiple biopsies of metastatic sites, the most recent biopsy prior to study entry should be submitted for evaluation of hormone receptor status.
3. Subjects with disease confined only to bone may be included but subjects with purely sclerotic lesions may not participate in the study.
4. Disease must have been sensitive to anastrozole or letrozole therapy prior to disease progression. Sensitivity to anastrozole or letrozole is defined as either stable disease or better for >=6 months in the metastatic setting or relapse free for >=2 years in the adjuvant setting.
5. No more than two prior lines of therapy in the metastatic setting, of which no more than one was chemotherapy [Note: Simultaneous combination treatment is considered one line of therapy.]
6. Eastern Cooperative Oncology Group (ECOG) performance status score of <=1
7. Clinical laboratory values during Screening:
•hemoglobin >=10.0 g/dL
•neutrophils >=1.5 x 10^9/L
•platelets >=100 x 10^9/L
Note: Subjects need to meet the above 3 criteria independent of growth factors and transfusions
•total bilirubin <=1.5 x upper limit of normal (ULN)
•alanine (ALT) and aspartate (AST) aminotransferase <=2.5xULN
•alkaline phosphatase <=6xULN unless bone metastases with no liver disorder
•serum creatinine <1.5xULN or creatinine clearance >=50 mL/min
•serum potassium >=3.5 mM
•serum albumin >=3.0 g/dL
•clinically normal prothrombin time (PT) or international normalized ratio (INR) and partial thromboplastin time (PTT) per investigator assessment
8. Systolic blood pressure <160 mm Hg and diastolic blood pressure <95 mm Hg [Note: Hypertension controlled by antihypertensive therapy is permitted].
9. Cardiac ejection fraction >=50% measured by MUGA or ECHO done within 4 weeks before randomization
10. A bisphosphonate or denosumab may be initiated on the same day as the assigned study.
11 Willing and able to adhere to prohibitions and restrictions specified in this protocol
12 Signs an informed consent document within 4 weeks before randomization indicating she understands the purpose of and procedures required for the study and is willing to participate in the study
13 Signs the informed consent document within 4 weeks before randomization for pharmacogenomics research indicating willingness to participate in the pharmacogenomic component of the study, where local regulations permit. [Note: Refusal to give consent for this component does not exclude a subject from participation in this clinical study.]
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 250
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50
1. Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor [Note: Prior treatment with ketoconazole for <= 7 days is permitted and topical formulations of ketoconazole are permitted]
2. Anticancer immunotherapy or investigational agent within 4 weeks before randomization, or anticancer radiotherapy (except palliative) or anticancer endocrine therapy within 2 weeks before randomization [Note: Potential subjects must not have taken anastrozole, letrozole, fulvestrant, or any chemotherapy for at least 2 weeks (bevacizumab for at least 3 weeks) before randomization.]
3. Serious or uncontrolled nonmalignant disease, including active or uncontrolled infection
4. Clinical or biochemical evidence of hyperaldosteronism or hypopituitarism
5. Any condition that, in the opinion of the investigator, would compromise the well-being of the patient or that could prevent, limit, or confound the protocol-specified assessments
6. Major thoracic or abdominal surgery or significant traumatic injury with 4 weeks before randomization or plans surgery during study participation or within 4 weeks after the last dose of study drug [Note: Patients with planned surgical procedures to be conducted under local anesthesia are not excluded from the study.]
7. Persistent >=Grade 2 toxicity from any cause [Note: Chemotherapy-induced alopecia and Grade 2 peripheral neuropathy are allowed.]
8. Symptomatic central nervous system disease or leptomeningeal disease
9. Gastrointestinal disorder interfering with study drug absorption
10. Active or uncontrolled disease that may require oral corticosteroid therapy
11. Active or symptomatic viral hepatitis or chronic liver disease
12. History of clinically significant heart disease, ie, myocardial infarction or arterial thrombotic event within 6 months, severe or unstable angina, or New York Heart Association Class III or IV heart disease
13. Known allergies, hypersensitivity, or intolerance to abiraterone acetate, exemestane, prednisone, or their excipients
14. Contraindications to the use of exemestane or prednisone per local prescribing information
15. Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 4 weeks before the planned first dose of study drug or is currently enrolled in an investigational study
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