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To study side effects and benefits of tablet Palbociclib in metastatic breast cancer patients within period of January 2016 till December 2018.

Analysis of clinical characteristics, toxicities and outcomes of hormone receptor positive, her 2 negative metastatic breast cancer patients treated with CDK4/6 inhibitors palbociclib from January 2016 till December 2018

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/05/025231
Enrollment
200
Registered
2020-05-18
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: C50- Malignant neoplasm of breast

Interventions

Intervention1: Not applicable: Not applicable

Sponsors

Tata Memorial Centre
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i.Patients with histopathologically confirmed ER/PR positive and HER- 2 negative metastatic breast cancer. ii.Patients who have been started on palbociclib with atleast one record of treatment with palbociclib from the year January 2016 till December 2018 will be included in study. Data will be obtained from the electronic medical records from our hospital

Exclusion criteria

Exclusion criteria: i.Patients having HER- 2 positive metastatic breast cancer. ii.Patients receiving Palbacoclib or Ribocliclib under any industry sponsored trials iii.Patientâ??s on palbociclib but not having details on EMR

Design outcomes

Primary

MeasureTime frame
The primary objectives of the study includes study of efficacy of palbociclib including progression free survival and overall survival.Timepoint: January 2016 till December 2018.—

Secondary

MeasureTime frame
The secondary objectives include the analysis of toxicities including incidence of grade 3 or 4 neutropenia, anemia and diarrheaTimepoint: January 2016 till December 2018.—

Countries

India

Contacts

Public ContactYogesh Kembhavi

Tata Memorial Centre

sushmitarath73@gmail.com02224177201

Outcome results

None listed

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