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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01176916
Recruitment Status : Completed
First Posted : August 6, 2010
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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® Interventional Study is being proposed to collect data systematically and to assess the efficacy and safety of Aromasin® adjuvant setting in Chinese population.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: Aromasin (exemestane) Phase 4

Detailed Description:
This is interventional study and single arm study. N/A

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 564 participants
Masking: None (Open Label)
Official Title: A PROSPECTIVE PRAGMATIC CLINICAL TRIAL OF CHINA EARLY INVASIVE BREAST CANCER PATIENTS RECEIVING ADJUVANT THERAPY WITH AROMASIN
Actual Study Start Date : February 9, 2011
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane

Arm Intervention/treatment
Experimental: A Drug: Aromasin (exemestane)
the dosage, frequency and duration base on the LPD approved by SFDA.




Primary Outcome Measures :
  1. Time-to-event, where event is defined as the earliest occurrence any of the following: Locoregional/distant recurrence of the primary breast cancer; Appearance of 2nd primary or contralateral breast cancer; Death [ Time Frame: 7 years ]

Secondary Outcome Measures :
  1. The proportion of subjects experiencing the event [ Time Frame: 7 years ]
  2. The incidence rate (per annum) defined as a ratio of the number of events and the total exposure times (in years) to Aromasin® therapy [ Time Frame: 7 years ]
  3. The relationship between Her2 overexpression level and time-to-event [ Time Frame: 7 years ]
  4. The incidence of adverse events and discontinuation of Aromasin® due to adverse event [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   The patient must be postmenopausal woman.
Accepts Healthy Volunteers:   No
Criteria

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®).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176916


Locations
Show Show 53 study locations
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01176916    
Other Study ID Numbers: A5991093
NRA5990043 ( Other Identifier: Alias Study Number )
First Posted: August 6, 2010    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Keywords provided by Pfizer:
breast cancer
Aromasin
adjuvant chemotherapy
endocrine therapy
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs