Breast NeoplasmsNCT01239745
Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
An observational study of Breast Neoplasms, run by Pfizer at 11 sites in 3 countries.
Trial summary
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Aromasin
- Type of treatment
- Pill or oral medicine
- How many people
- 46 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Apr 2011to Oct 2011
- 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: Estrogen receptor positive early breast cancer patients
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 histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- Patients who are disease-free after 2 to 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).
- Metastatic breast cancer or a contra lateral tumour.
- Other concomitant adjuvant endocrine therapy.
- Other concomitant antineoplastic treatment.
- Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Croatia8 sites
General Hospital Karlovac
Karlovac, 47000
University Hospital Center Osijek
Osijek, 31000
General Hospital Pula
Pula, 52000
University Hospital Center Rijeka
Rijeka, 51000
University Hospital Center Split
Split, 21000
General Hospital Varazdin
Varaždin, 42000
Clinic for Tumors
Zagreb, 10000
University Hospital Center "Sestre milosrdnice"
Zagreb, 10000
Serbia2 sites
Institute for Oncology and Radiology of Serbia
Belgrade, 11000
Oncology Clinic, Medical center, Bezanijska Kosa
Belgrade, 11080
About this study
Official title: A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.
Read the detailed description
The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
- Conditions
- Breast Neoplasms
- Being tested
- Aromasin
- Keywords
- Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AromasinDrug
Also called Exemestane
Aromasin® one 25 mg tablet to be taken once daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Drug: Aromasin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) 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 Month 36
Secondary outcomes (7)
Number of Participants With Concomitant Morbidities
Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
Measured: Baseline up to Month 36
Number of Participants With Concomitant Medications
Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.
Measured: Baseline up to Month 36
Percentage of Participants Who Discontinued the Study Medication
Measured: Baseline up to Month 36
Number of Participants With Reasons for Discontinuation From Study Medication
Measured: Baseline up to Month 36
Time to Discontinuation
Measured: Baseline up to Month 36
Recurrence-free Survival
Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.
Measured: Baseline up to Month 36
Overall Survival
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Measured: Baseline until death (up to Month 36)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startApr 2011
- Primary completionOct 2011
- Study completionOct 2011
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 Breast NeoplasmsStudies 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 46 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
- NCT01239745
- Sponsor's protocol ID
- A5991094
- Status last verified
- Oct 2012
- First submitted
- 3 Nov 2010
- Last updated
- 31 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
- ClinicalTrials.gov ID
- NCT01239745
- Acronym / sponsor ID
- A5991094
- Conditions
- Breast Neoplasms
- Keywords
- Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Posted 31 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.
Detailed description
The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Drug: Aromasin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Estrogen receptor positive early breast cancer patients
Key inclusion criteria (8 listed)
- Postmenopausal females, defined as one from the next :
- Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- Patients who are disease-free after 2 to 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 (5 listed)
- Patients for whom Aromasin® treatment is contraindicated (see SmPC).
- Metastatic breast cancer or a contra lateral tumour.
- Other concomitant adjuvant endocrine therapy.
- Other 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: ExemestaneAromasin® one 25 mg tablet to be taken once daily | Drug | 1 |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Baseline up to Month 36
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
7 secondary outcomes
Number of Participants With Concomitant Morbidities
Time frame: Baseline up to Month 36
Number of Participants With Concomitant Medications
Time frame: Baseline up to Month 36
Percentage of Participants Who Discontinued the Study Medication
Time frame: Baseline up to Month 36
Number of Participants With Reasons for Discontinuation From Study Medication
Time frame: Baseline up to Month 36
Time to Discontinuation
Time frame: Baseline up to Month 36
Recurrence-free Survival
Time frame: Baseline up to Month 36
Overall Survival
Time frame: Baseline until death (up to Month 36)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2012.
- 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.
Related trials for Breast Neoplasms
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Pfizer at 11 sites in 3 countries.
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 5 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 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Croatia, Serbia, Estonia. 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 31 Oct 2012). 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 Adverse Events (AEs) (time frame: Baseline up to Month 36). 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 31 Oct 2012.