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Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

Last updated on November 11, 2019

FOR MORE INFORMATION
Study Location
General Hospital Karlovac
Karlovac, , 47000 Croatia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01239745
Pfizer
Terminated
Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

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Descriptive Information
Brief TitleAromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
Official TitleA 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
Brief SummaryThis 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 DescriptionThe 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 TypeObservational
Study DesignObservational Model: Case Control
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationEstrogen receptor positive early breast cancer patients
ConditionBreast Neoplasms
InterventionDrug: Aromasin
Aromasin® one 25 mg tablet to be taken once daily
Other Name: Exemestane
Study Groups/Cohorts1
Intervention: Drug: Aromasin
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusTerminated
Actual Enrollment
 (submitted: October 11, 2012)
46
Original Estimated Enrollment
 (submitted: November 10, 2010)
350
Actual Study Completion DateOctober 2011
Actual Primary Completion DateOctober 2011   (Final data collection date for primary outcome measure)
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 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.

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study:Female
AgesChild, Adult, Older Adult
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesCroatia,   Estonia,   Serbia
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01239745
Other Study ID NumbersA5991094
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2012

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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