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

• ClinicalTrials.gov Identifier: NCT04874025
• Recruitment Status: Not yet recruiting
• First Posted: May 5, 2021
• Last Update Posted: July 28, 2021
• Sponsor: Hospital San Carlos, Madrid
• Information provided by (Responsible Party): Fernando Moreno Antón, Hospital San Carlos, Madrid

Study Description

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 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.

Condition or disease	Intervention/treatment
Breast Cancer	Drug: Ibrance

Study Design

• Study Type: Observational
• Estimated Enrollment: 700 participants
• Observational Model: Cohort
• Time Perspective: Other
• Official 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.
• Estimated Study Start Date: July 31, 2021
• Estimated Primary Completion Date: June 1, 2022
• Estimated Study Completion Date: December 1, 2022

Groups and Cohorts

Intervention Details:

• Drug: Ibrance
  Observational study of Ibrance 75 mg, 100 mg and 125 mg.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

1. Overall Survival [ Time Frame: Time Frame: From date of index treatment until date of death from any acuse 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 treatemnt 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Sampling Method: Non-Probability Sample

Study Population

Patients with advanced or metastatic breast cancer receiving palbociclib in first line in 35 Hospitals from Spain.

Criteria

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-

  1. HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
  2. 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 avaliable.
• 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

Contacts and Locations

Contacts

Contact: Fernando Moreno; +0034-91330300 ext 7546; fmorenoa@salud.madrid.org

Sponsors and Collaborators

Hospital San Carlos, Madrid

More Information

• Responsible Party: Fernando Moreno Antón, Principal Investigator, Hospital San Carlos, Madrid
• ClinicalTrials.gov Identifier: NCT04874025
• Other Study ID Numbers: PALBOSPAIN
• First Posted: May 5, 2021
• Last Update Posted: July 28, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fernando Moreno Antón, Hospital San Carlos, Madrid:

Breast Cancer.; Real-world data.; Palbociclib

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Palbociclib; Antineoplastic Agents; Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action