Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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13 December 2021 |
Main ID: |
EUCTR2011-000621-80-FR |
Date of registration:
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16/06/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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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
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Scientific title:
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Randomized, Open-Label Study of Abiraterone Acetate (JNJ-212082) Plus Prednisone With or Without Exemestane in Postmenopausal Women With ER+ Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy |
Date of first enrolment:
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23/01/2014 |
Target sample size:
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300 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-000621-80 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 3
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Ireland
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Italy
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Korea, Republic of
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Netherlands
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Poland
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Russian Federation
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Spain
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Janssen Biologics BV-Clinical Registry Group Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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3171524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Janssen Biologics BV-Clinical Registry Group Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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3171524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: 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. ER+, Her2 - metastatic breast cancer, confirmed within 7 days before randomization with FFPE tissue from either primary or metastatic breast cancer site, that recurred during or within 6 months of discontinuing anastrozole or letrozole therapy in adjuvant or metastatic setting; subjects with disease confined only to bone may be included.
3. 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.
4. 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.]
5. Eastern Cooperative Oncology Group (ECOG) performance status score of <=1
6. Clinical laboratory values during Screening:
•hemoglobin >=10.0 g/dL
•neutrophils >=1.5 x 10^9/L
•platelets >=100 x 10^9/L
•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
•prothrombin time (PT) and partial thromboplastin time (PTT) within normal limits [Exception: PT and international normalized ratio (INR) will be abnormally prolonged in subjects taking warfarin.]
7. Systolic blood pressure <160 mm Hg and diastolic blood pressure <95 mm Hg [Note: Hypertension controlled by antihypertensive therapy is permitted].
8. Cardiac ejection fraction >=50% measured by MUGA or ECHO done within 4 weeks before randomization
9. If receiving a bisphosphonate or denosumab, dose must have been stable for at least 2 doses before randomization.
10. Willing and able to adhere to prohibitions and restrictions specified in this protocol
11. 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
12. 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
Exclusion criteria: 1. Prior treatment with exemestane, ketoconazole, aminoglutethimide, or a CYP17 inhibitor
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 study entry.]
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 autoimmune disease that may require 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
Age minimum:
Age maximum:
Gender:
Female: yes Male: no
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Metastatic Breast Cancer MedDRA version: 14.0
Level: LLT
Classification code 10027475
Term: Metastatic breast cancer
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Product Name: Abiraterone acetate Product Code: JNJ-212082 Pharmaceutical Form: Tablet INN or Proposed INN: Abiraterone acetate CAS Number: 154229-18-2 Current Sponsor code: CB7630 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250-
Product Name: Prednisolone Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 50-24-8 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5-
Product Name: exemestane Pharmaceutical Form: Coated tablet INN or Proposed INN: EXEMESTANE CAS Number: 107868-30-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Up to approximately 1.5 years
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Main Objective: The primary objective is to assess safety and efficacy of abiraterone acetate plus prednisone and abiraterone acetate plus prednisone plus exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer progressing after letrozole or anastrozole therapy.
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Primary end point(s): Progression free survival
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Secondary Objective: Secondary objectives are to assess abiraterone acetate plus prednisone and abiraterone acetate plus prednisone combined with exemestane, each compared with exemestane alone, in postmenopausal women with ER+ metastatic breast cancer progressing after letrozole or anastrozole therapy, with respect to the following: •Overall survival •Overall response rate •Patient-reported outcomes (PROs) EORTC-C30, EQ-5D-5L, and BPI-SF pain intensity scale •Endocrine markers estradiol, testosterone, estrone, and other biomarkers •PK characterization of abiraterone and exemestane
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: 1. Up to approximately 3.5 years
2. Up to 1.5 years
3. Up to approximately 3.5 years
4. Up to approximately 1.5 years
5. Approximately 4 months
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Secondary end point(s): 1. Overall survival
2. Overall response rate to treatment
3. Patient-reported outcomes
4. Pharmacodynamics
5. Pharmacokinetics
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Secondary ID(s)
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2011-000621-80-BE
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212082BCA2001
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Source(s) of Monetary Support
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Janssen Research & Development
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Ethics review
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Status: Approved
Approval date: 23/01/2014
Contact:
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