Status:
COMPLETED
Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer
Lead Sponsor:
Hospital San Carlos, Madrid
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance aft...
Eligibility Criteria
Inclusion
- 1\. Documented histologically confirmed breast cancer with ER and/or PgR positive and HER2 negative status.
- 2\. Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
- 3\. HR+/HER2-
- HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
- HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
- 4\. Female or male patients \> 18 years
- 5\. Have received at least one dose of palbociclib
- 6\. At least 2 document clinical visits
- 7\. Treatment with palbociclib should have started from November 2017 to November 2019
- 8\. Data from the clinical records should be available.
- 9\. Patients must be able to understand and sign informed consent if alive.
Exclusion
- 1\. Previous treatment with hormonal therapy, targeted therapy or chemotherapy for metastatic disease. Previous anticancer treatment for early breast cancer are allowed.
- 2\. Treatment with palbociclib in clinical trial or compassionate use programs
- 3\. HER2 + (IHC 3+ or FISH +) tumors in the most recent or previous biopsies
- 4\. HR negative tumors in the most recent biopsy
Key Trial Info
Start Date :
July 31 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 8 2022
Estimated Enrollment :
815 Patients enrolled
Trial Details
Trial ID
NCT04874025
Start Date
July 31 2021
End Date
June 8 2022
Last Update
August 8 2022
Active Locations (36)
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1
Hospital Universitario Reina Sofía
Córdoba, Andalusia, Spain, 14004
2
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain, 18014
3
Hospital Universitario Virgen Macarena
Seville, Andalusia, Spain, 41009
4
Hospital Univesitario Virgen del Rocío
Seville, Andalusia, Spain, 41013