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A prevalence of PIK3CA mutations in patients with advanced breast cancer (ABC)

?A descriptive study of PIK3CA mutations in patients with HR+/Her2-advanced breast cancer ? (PIK3CA Registry Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/09/027638
Enrollment
2050
Registered
2020-09-07
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: R978- Other abnormal tumor markers

Interventions

Intervention1: NA: NA Control Intervention1: NA: NA

Sponsors

Novartis Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: Non applicable

Design outcomes

Primary

MeasureTime frame
To describe the frequency of PIK3CA mutations in men and women with HR+ HER2- advanced breast cancer.Timepoint: 1 year

Secondary

MeasureTime frame
To explore the relationship between PIK3CA status and clinical outcomes in the advanced setting.Timepoint: 1 year;To characterize treatment patterns in the advanced setting among ABC patients,by PIK3CA mutation status.Timepoint: 1 year

Countries

Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Egypt, France, Greece, Hong Kong, Hungary, India, Italy, Jordan, Kuwait, Latvia, Lebanon, Malaysia, Mexico, Netherlands, Qatar, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom

Contacts

Public ContactMurugananthan K

Novartis Healthcare PVT LTD

murugananthan.k@novartis.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026