Invasive Early Breast CancerNCT01121549
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
An observational study of Invasive Early Breast Cancer, run by Pfizer at 40 sites in Romania.
Trial summary
The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Invasive Early Breast Cancer
- What is being tested?
- Aromasin
- How many people
- 378 participants
- Where
- 40 sitesRomania
- Study dates
- Feb 2010to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy
Who may be able to join
- Postmenopausal females, defined as one from the next :
- Natural menopause >/=1 year,
- Surgical ovariectomy,
- Chemotherapy-induced amenorrhoea >/=2 years.
- Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
- Patients whose tumour was estrogen receptor positive (ER+).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Who cannot join
- Patients for whom Aromasin® treatment is contraindicated (see SmPC).
- Presence of metastasis or a contra lateral tumour.
- Other adjuvant endocrine therapy.
- Another concomitant antineoplastic treatment
- Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
- The patients are not supposed to participate to any other trial during all the study period.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
Romania40 sites
Spitalul Judetean de Urgenta Bacau
Bacau, Bacău, 600114
Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala
Bistriţa, Jud. Nasaud, 420178
Spitalul Judeţean Brasov
Brasov, Jud. Brasov, 505200
CMDT MAPN Washington Ambulator oncologie
Bucharest, Bucharest, 011794
Centru D.T. Titan Cabinet oncologie
Bucharest, Bucharest, 030442
Ambulator Spital Colentina, cabinet oncologie
Bucharest, 020142
Cabinet Oncologie Medicala
Bucharest, 020947
Ambulator Spital Sf. Pantelimon, cabinet oncolgie
Bucharest, 021659
Institutul Oncologic "Prof. Dr. Al. Trestioreanu"
Bucharest, 022328
Ambulator Spital Clinic Colţea, cabinet oncologie
Bucharest, 030171
Policlinica Sf. Ioan Bucuresti, cabinet oncologie
Bucharest, 042121
Policlinica Theodor Burghele, cabinet oncologie
Bucharest, 50659
Ambulator Specialitate Cotroceni, cabinet oncolgie
Bucharest, 7000
Str. Povernei 42, Sector 1
Bucharest, 7000
Spitalul Municipal Campina Sectia oncologie
Câmpina, Prahova, 107425
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
Cluj-Napoca, Cluj, 400015
Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Oncologie Medicala si Radioterapie
Cluj-Napoca, Cluj, 40006
Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie
Drobeta-Turnu Severin, Mehedinți County, 220064
Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei
Galati, Jud. Galati, 800367
Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala
Hunedoara, Hunedoara County, 331021
Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o
Iași, Iaşi, 700106
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala
Iași, Iaşi, 700111
Spitalul Municipal Medias Compartimentul Oncologie medicala
Mediaş, Sibiu County, 551026
Spital Clinic Judetean de Urgenta Oradea
Oradea, Jud. Bihor, 410167
Spitalul Clinic de Urgenta
Oradea, 410032
Policlinica Judeteana 1 Pitesti - Cabinet oncologie
Piteşti, Argeş, 110084
Spitalul Municipal Ploiesti Sectia oncologie
Ploieşti, Prahova, 100337
Spitalul Judetean de Urgenta Resita Sectia oncologie medicala
Reşiţa, Caraș-Severin County, 320076
Spitalulul Municipal de Urgenta Roman
Roman, Neamț County, 617385
Spitalul Judetean Covasna, Sectia Oncologie medicala
Sfantu Gheorghe, Covasna, 520064
Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala
Sibiu, Jud. Sibiu, 550245
Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala
Sibiu, Sibiu County, 550245
Spitalul Judetean de Urgenta Slatina, Sectie oncologie
Slatina, Olt, 230008
Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou
Suceava, Suceava, 720131
Spitalul Judetean de Urgenta Targoviste
Targoviste, Dâmbovița County, 130095
Spitalul Judetean de Urgenta Targu Jiu, Ambulator Spital - Oncologie medicala
Târgu Jiu, 210140
Spitalul Judetean Targu Mures
Târgu Mureş, Mureș County, 540140
Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala
Timișoara, Timiș County, 300223
Spitalul Clinic Municipal Timisoara Sectia oncologie medicala
Timișoara, Timiș County, 300223
Oncomed Srl
Timișoara, Timiș County, 300239
About this study
Official title: A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy
The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.
Read the detailed description
This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.
- Conditions
- Invasive Early Breast Cancer
- Being tested
- Aromasin
- Keywords
- Prospective, non-comparative, NIS, 600, postmenopausal, hormone-receptor, positive, EBC, tamoxifen, current medical practice.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromasinDrug
Also called exemestane
25 mg daily continuously
| Study group | Role | What they receive |
|---|---|---|
| Aromasin | All patients included in the study Receives: Drug: Aromasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).
Measured: Baseline up to 28 days after last dose
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Measured: Baseline up to 28 days after last dose
Secondary outcomes (6)
Number of Missed Exemestane Doses
Measured: Week 25, 49, 73, 97, 121, 145
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Measured: Baseline up to Year 3
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
Measured: Baseline up to Year 3
Percentage of Participants Who Discontinued the Exemestane Therapy
Measured: Baseline up to Year 3
Recurrence-free Survival (RFS)
Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.
Measured: Baseline up to Year 3
Time to Disease Progression (TTP)
Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.
Measured: Baseline up to Year 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Invasive Early Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121549
- Sponsor's protocol ID
- A5991091
- Status last verified
- Dec 2013
- First submitted
- 30 Mar 2010
- Last updated
- 22 Jan 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer In Postmenopausal Hormone Receptors Positive Patients Following Of 2-3 Years of Initial Adjuvant Tamoxifen Therapy
- ClinicalTrials.gov ID
- NCT01121549
- Acronym / sponsor ID
- A5991091
- Conditions
- Invasive Early Breast Cancer
- Keywords
- Prospective, non-comparative, NIS, 600, postmenopausal, hormone-receptor, positive, EBC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 378 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 May 2010 (estimated)
- Results
- Posted 22 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The IES study (A5991012) investigated 4742 patients treated for 2 to 3 years with tamoxifen, who either continued the same treatment or switched to Aromasin® for a total treatment period of 5 years. Only 65 Romanian patients were enrolled in the IES study. It would therefore appear to be essential to evaluate and confirm the tolerability of Aromasin® and the ways in which it is used on a broader sample of patients and under the standard conditions of use as stipulated in the MA. This Non-Interventional study was designed to address these issues.
Detailed description
This is a prospective, non-comparative, non interventional study (NIS) in four hundred (400) postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy conducted in 60 sites from Romania according to protocol A5991091.The selection of patients based on diagnosis, the attribution of medicinal products and the follow-up of the subjects fall within the current medical practice. A Non-Interventional study is primarily observational in nature. The present Non-interventional Study is performed by medical oncologist and medical oncologist /radiation oncologist who agree to take part in this project. n/a The study was prematurely terminated on August 31th 2012 due to unexpected high rate of patient withdrawal caused by Aromasin reimbursement policy change in Romania; There were no safety issues related to study termination.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aromasin | – | Drug: AromasinAll patients included in the study |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy
Key inclusion criteria (8 listed)
- Postmenopausal females, defined as one from the next :
- Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
- Patients whose tumour was estrogen receptor positive (ER+).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Key exclusion criteria (6 listed)
- Patients for whom Aromasin® treatment is contraindicated (see SmPC).
- Presence of metastasis or a contra lateral tumour.
- Other adjuvant endocrine therapy.
- Another concomitant antineoplastic treatment
- Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AromasinAlso: exemestane25 mg daily continuously | Drug | Aromasin |
Primary outcome
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Time frame: Baseline up to 28 days after last dose
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living [ADL]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
Time frame: Baseline up to 28 days after last dose
An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
6 secondary outcomes
Number of Missed Exemestane Doses
Time frame: Week 25, 49, 73, 97, 121, 145
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Time frame: Baseline up to Year 3
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
Time frame: Baseline up to Year 3
Percentage of Participants Who Discontinued the Exemestane Therapy
Time frame: Baseline up to Year 3
Recurrence-free Survival (RFS)
Time frame: Baseline up to Year 3
Time to Disease Progression (TTP)
Time frame: Baseline up to Year 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Early Breast Cancer, run by Pfizer at 40 sites in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity (time frame: Baseline up to 28 days after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.