A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01121549
First received: March 30, 2010
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Invasive Early Breast Cancer |
Drug: Aromasin |
Phase 4 |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Overall Safety profile characterized by type, frequency and severity, as graded is using the NCI/CTEP Common Technology Criteria for Adverse Events version 4.0 (CTCAE, v4.0) and its relationship with study therapy [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Safety profile characterized by type, frequency and severity, as graded is using the NCI/CTEP Common Technology Criteria for Adverse Events version 4.0 (CTCAE, v4.0) and its relationship with study therapy. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Safety profile characterized by type, frequency and severity, as graded is using the NCI/CTEP Common Technology Criteria for Adverse Events version 4.0 (CTCAE, v4.0) and its relationship with study therapy. [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- Safety profile characterized by type, frequency and severity, as graded is using the NCI/CTEP Common Technology Criteria for Adverse Events version 4.0 (CTCAE, v4.0) and its relationship with study therapy. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- Safety profile characterized by type, frequency and severity, as graded is using the NCI/CTEP Common Technology Criteria for Adverse Events version 4.0 (CTCAE, v4.0) and its relationship with study therapy. [ Time Frame: 30 and 36 months (if applicable) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the profile of patients treated with Aromasin® (age, type of tumour, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To determine the profile of patients treated with Aromasin® (age, type of tumour, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To determine the profile of patients treated with Aromasin® (age, type of tumour, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To determine the profile of patients treated with Aromasin® (age, type of tumour, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy) [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- To determine the profile of patients treated with Aromasin® (age, type of tumour, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy) [ Time Frame: 30 months (if applicable) ] [ Designated as safety issue: No ]
- To determine the profile of patients treated with Aromasin® (age, type of tumour, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy) [ Time Frame: 36 months (if applicable) ] [ Designated as safety issue: No ]
- To evaluate compliance and the reasons for any discontinuation of Aromasin® therapy and the type of treatment administered afterwards (hormonal therapy or chemotherapy) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To evaluate compliance and the reasons for any discontinuation of Aromasin® therapy and the type of treatment administered afterwards (hormonal therapy or chemotherapy) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To evaluate compliance and the reasons for any discontinuation of Aromasin® therapy and the type of treatment administered afterwards (hormonal therapy or chemotherapy) [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- To evaluate compliance and the reasons for any discontinuation of Aromasin® therapy and the type of treatment administered afterwards (hormonal therapy or chemotherapy) [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- To evaluate compliance and the reasons for any discontinuation of Aromasin® therapy and the type of treatment administered afterwards (hormonal therapy or chemotherapy) [ Time Frame: 30 months (if applicable) ] [ Designated as safety issue: Yes ]
- To evaluate compliance and the reasons for any discontinuation of Aromasin® therapy and the type of treatment administered afterwards (hormonal therapy or chemotherapy) [ Time Frame: 36 months (if applicable) ] [ Designated as safety issue: Yes ]
- To evaluate the rate of treatment discontinuation [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- To evaluate the rate of treatment discontinuation [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- To evaluate the rate of treatment discontinuation [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]
- To evaluate the rate of treatment discontinuation [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- To evaluate the rate of treatment discontinuation [ Time Frame: 30 months (if applicable) ] [ Designated as safety issue: Yes ]
- To evaluate the rate of treatment discontinuation [ Time Frame: 36 months (if applicable) ] [ Designated as safety issue: Yes ]
- To evaluate recurrence-free survival (time from the inclusion to date of confirmation of any recurrence - as local or distant recurrence; new primary ipsilateral or controlateral breast cancer, death) and time to disease progression. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- To evaluate recurrence-free survival (time from the inclusion to date of confirmation of any recurrence - as local or distant recurrence; new primary ipsilateral or controlateral breast cancer, death) and time to disease progression. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To evaluate recurrence-free survival (time from the inclusion to date of confirmation of any recurrence - as local or distant recurrence; new primary ipsilateral or controlateral breast cancer, death) and time to disease progression. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- To evaluate recurrence-free survival (time from the inclusion to date of confirmation of any recurrence - as local or distant recurrence; new primary ipsilateral or controlateral breast cancer, death) and time to disease progression. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
- To evaluate recurrence-free survival (time from the inclusion to date of confirmation of any recurrence - as local or distant recurrence; new primary ipsilateral or controlateral breast cancer, death) and time to disease progression. [ Time Frame: 30 months (if applicable) ] [ Designated as safety issue: No ]
- To evaluate recurrence-free survival (time from the inclusion to date of confirmation of any recurrence - as local or distant recurrence; new primary ipsilateral or controlateral breast cancer, death) and time to disease progression. [ Time Frame: 36 months (if applicable) ] [ Designated as safety issue: No ]
| Enrollment: | 378 |
| Study Start Date: | February 2010 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Aromasin
All patients included in the study
|
Drug: Aromasin
25 mg daily continuously
Other Name: exemestane
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Postmenopausal women hormone-receptor positive invasive with early breast cancer, following 2-3 years of initial adjuvant tamoxifen therapy
Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01121549
Locations
| Romania | |
| Policlinica Judeteana 1 Pitesti - Cabinet oncologie | |
| Pitesti, Arges, Romania, 110084 | |
| Spitalul Judetean de Urgenta Resita Sectia oncologie medicala | |
| Resita, Caras Severin, Romania, 320076 | |
| Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Oncologie Medicala si Radioterapie | |
| Cluj Napoca, Cluj, Romania, 40006 | |
| Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca | |
| Cluj-Napoca, Cluj, Romania, 400015 | |
| Spitalul Judetean Covasna, Sectia Oncologie medicala | |
| Sfantu Gheorghe, Covasna, Romania, 520064 | |
| Spitalul Judetean de Urgenta Targoviste | |
| Targoviste, Dambovita, Romania, 130095 | |
| Spital Clinic Judetean de Urgenta Oradea | |
| Oradea, Jud. Bihor, Romania, 410167 | |
| Spitalul Judeţean Brasov | |
| Brasov, Jud. Brasov, Romania, 505200 | |
| Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei | |
| Galati, Jud. Galati, Romania, 800367 | |
| Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala | |
| Bistrita, Jud. Nasaud, Romania, 420178 | |
| Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala | |
| Sibiu, Jud. Sibiu, Romania, 550245 | |
| Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie | |
| Drobeta Turnu Severin, Mehedinti, Romania, 220064 | |
| Spitalul Judetean Targu Mures | |
| Targu Mures, Mures, Romania, 540140 | |
| Spitalulul Municipal de Urgenta Roman | |
| Roman, Neamt, Romania, 617385 | |
| Spitalul Judetean de Urgenta Slatina, Sectie oncologie | |
| Slatina, Olt, Romania, 230008 | |
| Spitalul Municipal Campina Sectia oncologie | |
| Campina, Prahova, Romania, 107425 | |
| Spitalul Municipal Ploiesti Sectia oncologie | |
| Ploiesti, Prahova, Romania, 100337 | |
| Spitalul Municipal Medias Compartimentul Oncologie medicala | |
| Medias, Sibiu, Romania, 551026 | |
| Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala | |
| Timisoara, Timis, Romania, 300223 | |
| Spitalul Clinic Municipal Timisoara Sectia oncologie medicala | |
| Timisoara, Timis, Romania, 300223 | |
| Oncomed Srl | |
| Timisoara, Timis, Romania, 300239 | |
| Spitalul Judetean de Urgenta Bacau | |
| Bacau, Romania, 600114 | |
| Policlinica Theodor Burghele, cabinet oncologie | |
| Bucharest, Romania, 50659 | |
| Str. Povernei 42, Sector 1 | |
| Bucharest, Romania, 7000 | |
| Ambulator Spital Clinic Colţea, cabinet oncologie | |
| Bucuresti, Romania, 030171 | |
| Centru D.T. Titan Cabinet oncologie | |
| Bucuresti, Romania, 030442 | |
| Institutul Oncologic "Prof. Dr. Al. Trestioreanu" | |
| Bucuresti, Romania, 022328 | |
| Ambulator Spital Colentina, cabinet oncologie | |
| Bucuresti, Romania, 020142 | |
| Cabinet Oncologie Medicala | |
| Bucuresti, Romania, 020947 | |
| Policlinica Sf. Ioan Bucuresti, cabinet oncologie | |
| Bucuresti, Romania, 042121 | |
| CMDT MAPN Washington Ambulator oncologie | |
| Bucuresti, Romania, 011794 | |
| Ambulator Spital Sf. Pantelimon, cabinet oncolgie | |
| Bucuresti, Romania, 021659 | |
| Ambulator Specialitate Cotroceni, cabinet oncolgie | |
| Bucuresti, Romania, 7000 | |
| Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala | |
| Hunedoara, Romania, 331021 | |
| Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o | |
| Iasi, Romania, 700106 | |
| Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala | |
| Iasi, Romania, 700111 | |
| Spitalul Clinic de Urgenta | |
| Oradea, Romania, 410032 | |
| Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala | |
| Sibiu, Romania, 550245 | |
| Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou | |
| Suceava, Romania, 720131 | |
| Spitalul Judetean de Urgenta Targu Jiu, Ambulator Spital - Oncologie medicala | |
| Targu Jiu, Romania, 210140 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01121549 History of Changes |
| Other Study ID Numbers: | A5991091 |
| Study First Received: | March 30, 2010 |
| Last Updated: | May 20, 2013 |
| Health Authority: | Romania: Romanian National Medicine Agency |
Keywords provided by Pfizer:
|
Prospective non-comparative NIS 600 postmenopausal |
hormone-receptor positive EBC tamoxifen current medical practice. |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Adjuvants, Immunologic Exemestane Immunologic Factors |
Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013