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NCT Number: NCT04874025

Observational Analysis of Palbociclib Treatment in Patients With First Line Therapy for Locally Advanced and/or Metastatic Breast Cancer

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 after exposure to one or more treatment lines.

The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer.

These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant.

In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Reina Sofía, Córdoba, Andalusia, Spain

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Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Ibrance

Drug

Observational study of Ibrance 75 mg, 100 mg and 125 mg.

Primary outcomes

  1. Real-world progression free survival (rwPFS)

    Time frame: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 52 months

    Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months

Secondary outcomes

  1. Overall Survival

    Time frame: Time Frame: From date of index treatment until date of death from any accuse or date of end of study, whichever came first, assessed up to 52 months

    Median time (months) from date of index treatment to date of death. Patients who did not die in the study period are censored at their last date in the study.

  2. Real-world tumor response (rwTR)

    Time frame: From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months

    Real-world tumor response is defined as complete response or partial response, based on treating clinician's assessment of radiological evidence for change in burden of disease over the course of treatment

  3. Time to next line of therapy

    Time frame: From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months

    Median time (months) from date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months

  4. Time to first use of chemotherapy

    Time frame: From date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months

    Median time (months) from date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months

Sponsors and collaborators

Lead sponsor

Hospital San Carlos, Madrid

Other

Registry information

Official study title

Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and / or Metastatic RH + / HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice.

Acronym: PALBOSPAIN

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 5, 2021
Registry last updated
Aug 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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