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Study to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer

NCT02491983

Description:

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

URL:

https://clinicaltrials.gov/show/NCT02491983

Trial Eligibility

Document

Title

  • Brief Title: Study to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Locally Advanced or Metastatic Breast Cancer
  • Official Title: A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: MedOPP067
  • SECONDARY ID: 2014-004698-17
  • NCT ID: NCT02491983

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
PalbociclibPD-0332991Arm A
FulvestrantFaslodexArm B
LetrozoleFemaraArm A

Purpose

This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.

Detailed Description

      Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of
      metastatic disease diagnose (patients metastatic de novo versus non de novo).

Trial Arms

NameTypeDescriptionInterventions
Arm AActive ComparatorCombination of Palbociclib and Letrozole
  • Palbociclib
  • Letrozole
Arm BExperimentalCombination of Palbociclib and Fulvestrant
  • Palbociclib
  • Fulvestrant

Eligibility Criteria

        Inclusion Criteria:

          1. Women 18 years or older with metastatic or locally advanced disease, not amenable to
             curative therapy

          2. Confirmed diagnosis of HR+/HER2- breast cancer

          3. Post-menopausal status

          4. No prior chemotherapy line in the metastatic setting

          5. Measurable disease defined by RECIST version 1.1, or non-measurable disease

          6. Eastern Cooperative Oncology Group (ECOG) PS 0-1

          7. Adequate organ and marrow function, resolution of all toxic effects of prior therapy
             or surgical procedures

          8. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical
             procedures to NCICTCAE version 4.0 Grade equal or minor than 1

        Exclusion Criteria:

          1. ER or HER2 unknown disease

          2. HER2 positive disease based on local laboratory results

          3. Locally advanced breast cancer candidate for a radical treatment

          4. Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of
             treatment.

          5. Patients with rapidly progressive visceral disease or visceral crisis.

          6. Major surgery within 4 weeks of start of study drug

          7. Patients with an active, bleeding diathesis

          8. Serious concomitant systemic disorder incompatible with the study

          9. Are unable to swallow tablets

         10. Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day
             methylprednisolone equivalent

         11. Known active uncontrolled or symptomatic CNS metastases

         12. Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any
             PD-0332991 excipients

         13. QTc > 480 msec on basal assessments, personal history of long or short QT syndrome,
             Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes

         14. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging
             drug
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:1-year Progression Free Survival
Time Frame:Baseline up to 52 weeks after last patient entry
Safety Issue:
Description:Percentage of patients who are alive and without evidence of tumor progression at 52 weeks of study entry.

Secondary Outcome Measures

Measure:Grade 3/4 adverse events, SAEs, deaths and discontinuations •
Time Frame:Baseline up to 52 weeks after last patient entry
Safety Issue:
Description:
Measure:Time To Progression (TTP)
Time Frame:Baseline up to 52 weeks after last patient entry
Safety Issue:
Description:Time from randomization to disease progression
Measure:Overall Survival (OS)
Time Frame:Baseline up to 52 weeks after last patient entry
Safety Issue:
Description:Time from date of randomization to date of death due to any cause
Measure:Clinical Benefit Rate
Time Frame:Baseline up to 52 weeks after last patient entry
Safety Issue:
Description:Percentage of patients who experience a CR, PR or stable disease (for at least 24 weeks) and assessed by modified Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria.
Measure:Overall Response Rate
Time Frame:Baseline up to 52 weeks after last patient entry
Safety Issue:
Description:proportion of patients with best overall response of confirmed complete response (CR) or partial response (PR) based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:MedSIR

Trial Keywords

  • metastatic breast cancer
  • Endocrine receptors positive
  • HER-2 negative

Last Updated

November 27, 2020