Phase 4
N=564
Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT01176916 ↗Enrolled (actual)
564
Serious AEs
6.8%
Results posted
Oct 2020
Primary outcome: Primary: Time-to-Event — NA months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Aromasin (exemestane) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time-to-Event |
NA | — |
| SECONDARY Percentage of Participants Experiencing Each Event |
3.0; 0.4; 0.7 | — |
| SECONDARY Incidence Rate of Each Event |
0.02995; 0.00352; 0.00321 | — |
| SECONDARY Hazard Ratio: the Relationship Between (Human Epidermal Growth Factor Receptor 2) HER2 Status and Time-to-Event |
0.835 | — |
| SECONDARY Harzard Ratio: the Relationship Between Multiple Disease Variables and Time-to-Event |
2.079; 1.532 | — |
| SECONDARY Number of Participants With Discontinuation Due to Adverse Events (AEs) |
62; 47 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
345; 222 | — |
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.
Eligibility 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®).
Data sourced from ClinicalTrials.gov (NCT01176916). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.