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Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China

Last updated on May 18, 2018

FOR MORE INFORMATION
Study Location
The First Affiliated Hospital of Bengbu Medical College/Medical Oncology Department
Bengbu, Anhui, 233004 China
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

- Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.

- ER positive.

- The patient must be postmenopausal woman.

- The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will
switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will
necessarily precede and will be independent of the decision to enroll patients in the
study).

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

- Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving
Aromasin® treatment, there is evidence of a local relapse or distant metastasis of
breast cancer, or a second primary cancer.

- Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase
inhibitors (not Aromasin®).

NCT01176916
Pfizer
Recruiting
Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China

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Aromasin® Non-Interventional Study Of Early Invasive Breast Cancer Patients In China
A Prospective Pragmatic Clinical Trial Of China Early Invasive Breast Cancer Patients Receiving Adjuvant Therapy With Aromasin
Aromasin® (Exemestane) was approved in China for adjuvant treatment of postmenopausal women with estrogen receptor (ER) positive early invasive breast cancer who have received 2-3 years of tamoxifen & are switched to Aromasin® for completion of a total of 5 consecutive years of adjuvant hormonal therapy by State Food and Drug Administration (SFDA) with clinical trial waive. While Aromasin® has been used in China for adjuvant therapy of breast cancer since then, there is currently lack of systematic collection and analysis for the efficacy and safety data of Aromasin® adjuvant setting in Chinese population. The Aromasin® Non-Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.
This is non-interventional study and single arm study. N/A
Interventional
Phase 4
Masking: None (Open Label)
Breast Neoplasms
Drug: Aromasin (exemestane)
This is a NIS, the dosage, frequency and duration base on the LPD approved by SFDA.
A
This is a single arm NIS.
Intervention: Drug: Aromasin (exemestane)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
550
December 2018
December 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Early invasive breast cancer (T1-4N1-3M0) confirmed by histology or cytology.
  • ER positive.
  • The patient must be postmenopausal woman.
  • The patient has received adjuvant Tamoxifen therapy for up to 2-3 years and will switch to receive Aromasin® treatment (The decision to prescribe Aromasin® will necessarily precede and will be independent of the decision to enroll patients in the study).

Exclusion Criteria:

  • Following the adjuvant Tamoxifen therapy for 2-3 years and prior to receiving Aromasin® treatment, there is evidence of a local relapse or distant metastasis of breast cancer, or a second primary cancer.
  • Following the adjuvant Tamoxifen therapy for 2-3 years and received other aromatase inhibitors (not Aromasin®).
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Child, Adult, Senior
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
China
 
 
NCT01176916
A5991093
NRA5990043 ( Other Identifier: Alias Study Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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