Clinical trial NCT01121549: A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Invasive Early Breast Cancer
Keywords: Prospective
non-comparative
NIS
600
postmenopausal
hormone-receptor
positive
EBC
tamoxifen
current medical practice.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 378
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal females, defined as one from the next :

  1. Natural menopause \>/=1 year,
  2. Surgical ovariectomy,
  3. 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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
timeFrame: Baseline up to 28 days after last dose
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
timeFrame: Baseline up to 28 days after last dose
Secondary outcomes:
measure: Number of Missed Exemestane Doses
timeFrame: Week 25, 49, 73, 97, 121, 145
measure: Number of Participants With Reasons for Discontinuing Exemestane Therapy
timeFrame: Baseline up to Year 3
measure: Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
timeFrame: Baseline up to Year 3
measure: Percentage of Participants Who Discontinued the Exemestane Therapy
timeFrame: Baseline up to Year 3
measure: Recurrence-free Survival (RFS)
timeFrame: Baseline up to Year 3
measure: Time to Disease Progression (TTP)
timeFrame: Baseline up to Year 3
Other outcomes:
Locations:
city: Pitesti
country: Romania
facility: Policlinica Judeteana 1 Pitesti - Cabinet oncologie
state: Arges
city: Resita
country: Romania
facility: Spitalul Judetean de Urgenta Resita Sectia oncologie medicala
state: Caras Severin
city: Cluj Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj, Clinica de Oncologie Medicala si Radioterapie
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj Napoca
state: Cluj
city: Sfantu Gheorghe
country: Romania
facility: Spitalul Judetean Covasna, Sectia Oncologie medicala
state: Covasna
city: Targoviste
country: Romania
facility: Spitalul Judetean de Urgenta Targoviste
state: Dambovita
city: Oradea
country: Romania
facility: Spital Clinic Judetean de Urgenta Oradea
state: Jud. Bihor
city: Brasov
country: Romania
facility: Spitalul Judeţean Brasov
state: Jud. Brasov
city: Galati
country: Romania
facility: Spitalulul Judetean Clinic de Urgenta, Sf. Apostol Andrei
state: Jud. Galati
city: Bistrita
country: Romania
facility: Spitalul Judetean Bistrita Nasaud - Sectia Oncologie Medicala
state: Jud. Nasaud
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu - Sectia Oncologie Medicala
state: Jud. Sibiu
city: Drobeta Turnu Severin
country: Romania
facility: Spitalul Judetean Drobeta Turnu Severin - Sectie oncologie
state: Mehedinti
city: Targu Mures
country: Romania
facility: Spitalul Judetean Targu Mures
state: Mures
city: Roman
country: Romania
facility: Spitalulul Municipal de Urgenta Roman
state: Neamt
city: Slatina
country: Romania
facility: Spitalul Judetean de Urgenta Slatina, Sectie oncologie
state: Olt
city: Campina
country: Romania
facility: Spitalul Municipal Campina Sectia oncologie
state: Prahova
city: Ploiesti
country: Romania
facility: Spitalul Municipal Ploiesti Sectia oncologie
state: Prahova
city: Medias
country: Romania
facility: Spitalul Municipal Medias Compartimentul Oncologie medicala
state: Sibiu
city: Timisoara
country: Romania
facility: Spitalul Clinic Municipal de Urgenta Timisoara Clinica Oncologie Medicala
state: Timis
city: Timisoara
country: Romania
facility: Spitalul Clinic Municipal Timisoara Sectia oncologie medicala
state: Timis
city: Timisoara
country: Romania
facility: Oncomed Srl
state: Timis
city: Bacau
country: Romania
facility: Spitalul Judetean de Urgenta Bacau
city: Bucharest
country: Romania
facility: Policlinica Theodor Burghele, cabinet oncologie
city: Bucharest
country: Romania
facility: Str. Povernei 42, Sector 1
city: Bucuresti
country: Romania
facility: CMDT MAPN Washington Ambulator oncologie
city: Bucuresti
country: Romania
facility: Ambulator Spital Colentina, cabinet oncologie
city: Bucuresti
country: Romania
facility: Cabinet Oncologie Medicala
city: Bucuresti
country: Romania
facility: Ambulator Spital Sf. Pantelimon, cabinet oncolgie
city: Bucuresti
country: Romania
facility: Institutul Oncologic "Prof. Dr. Al. Trestioreanu"
city: Bucuresti
country: Romania
facility: Ambulator Spital Clinic Colţea, cabinet oncologie
city: Bucuresti
country: Romania
facility: Centru D.T. Titan Cabinet oncologie
city: Bucuresti
country: Romania
facility: Policlinica Sf. Ioan Bucuresti, cabinet oncologie
city: Bucuresti
country: Romania
facility: Ambulator Specialitate Cotroceni, cabinet oncolgie
city: Hunedoara
country: Romania
facility: Spitalulul Judetean de Urgenta Deva, Ambulator oncologie medicala
city: Iasi
country: Romania
facility: Spitalulul Clinic Judetean de Urgenta Sf. Spiridon, Ambulatoriu de specialitate adulti - Stationar o
city: Iasi
country: Romania
facility: Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi Clinica Oncologie Medicala
city: Oradea
country: Romania
facility: Spitalul Clinic de Urgenta
city: Sibiu
country: Romania
facility: Spitalulul Clinic Judetean de Urgenta Sibiu- Sectia Oncologie medicala
city: Suceava
country: Romania
facility: Spitalulul Judetean de Urgenta, Sf. Ioan cel Nou
city: Targu Jiu
country: Romania
facility: Spitalul Judetean de Urgenta Targu Jiu, Ambulator Spital - Oncologie medicala
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: