Breast Cancer Clinical Trial
Official title:
Fulvestrant Versus Everolimus Plus Exemestane for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitors: the Clinical Experience From Real -World
| NCT number | NCT03695341 |
| Other study ID # | YOUNGBC-3 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 14, 2018 |
| Est. completion date | May 15, 2019 |
| Verified date | June 2019 |
| Source | Fudan University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI
| Status | Completed |
| Enrollment | 130 |
| Est. completion date | May 15, 2019 |
| Est. primary completion date | March 10, 2019 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: 1. Patients diagnosed with ER/PR+,HER2- Metastatic Breast Cancer 2. Patients who were refractory to previous Aromatase Inhibitors 3. Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center,starting from 2013.06.01-2016.06.01 4. Available medical history Exclusion Criteria: 1.Incomplete medical history |
| Country | Name | City | State |
|---|---|---|---|
| China | Fudan University Shanghai Cancer Center | Shanghai | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Fudan University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | PFS | Progression free survival | 6 weeks | |
| Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | 6 weeks |
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