A prevalence of PIK3CA mutations in patients with advanced breast cancer (ABC)
Not Applicable
- Conditions
- Health Condition 1: R978- Other abnormal tumor markers
- Registration Number
- CTRI/2020/09/027638
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Written patient informed consent must be obtained prior to any data collection and
sample shipment to a local designated laboratory.
2. Patient is an adult male or female (>= 18 years of age).
3. Confirmed advanced (locoregionally recurrent not amenable to curative therapy or
metastatic) breast cancer.
4. Patient has a histologically and/or cytologically confirmed diagnosis of ER+ and/or
PgR+ , as well as Her2- breast cancer by local laboratory.
5. Patient has available a tumor tissue (archival or fresh) to be sent to a local lab for
PIK3CA testing.
6. Any lines of treatment for metastatic setting will be allowed.
Exclusion Criteria
Non applicable
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the frequency of PIK3CA mutations in men and women with HR+ HER2- advanced breast cancer.Timepoint: 1 year
- Secondary Outcome Measures
Name Time Method To characterize treatment patterns in the advanced setting among ABC patients,by PIK3CA mutation status.Timepoint: 1 year;To explore the relationship between PIK3CA status and clinical outcomes in the advanced <br/ ><br>setting.Timepoint: 1 year