Adjuvant Palbociclib in Elderly Patients With Breast Cancer

NCT03609047

Last updated date
Study Location
Centre Henri Becquerel
Rouen, , , France
Contact
+3227741611

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer Stage II, Breast Cancer Stage III
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
70 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Women or men with stage II or stage III, early invasive breast cancer according to the UICC 8th edition for TNM classification

- Histologically confirmed Estrogen Receptor ER+ (at least 10 % of cells staining positive for ER), Human Epidermal Growth Factor Receptor 2 (HER-2) negative, early invasive breast cancer based on results of local pathology. Testing may be performed on diagnostic core biopsy or resection specimen.

- In patients with multicentric, multifocal and/or bilateral breast cancer, all histopathologically examined invasive tumors must meet pathologic criteria regarding ER and HER2-status described above.

- Adjuvant chemotherapy indicated and feasible according to treating physician and patient, based on standard clinicopathological parameters (tumor size, lymph node involvement, general health status, proliferation marker, patient wish) and gene expression profile if available.

- Adjuvant chemotherapy combining both anthracycline and taxanes considered not indicated or not feasible according to treating physician.

- No evidence of macroscopic distant metastases, investigated according to local institutional guidelines.

- Age ≥70 years

- Eastern Cooperative Oncology Group (ECOG) Performance status 0-2

- Patient must have undergone breast +/- axillary surgery with curative intent for the current malignancy ≤8 weeks before randomization.

- The maximum duration from last surgery to the start of the first adjuvant treatment is 9 weeks.

- Patients must have sufficient resolution of any surgical side effects from the last surgery per physician assessment, with no active wound healing complications at the time of randomization.

- Incentive to undergo adjuvant radiation therapy when indicated per local institutional guidelines.

- Note: For patients in the palbociclib arm, radiation therapy when indicated has to start ≤9 weeks after last surgery. The endocrine therapy can be initiated during or after the radiation therapy but not later than 3 weeks after the last radiotherapy. Palbociclib has to start ≤3 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy and palbociclib have to be initiated ≤9 weeks after last surgery.

- Note: For patients in the chemotherapy arm, chemotherapy has to be the first adjuvant treatment and has to start ≤9 weeks after the last surgery. When radiation therapy is indicated, this treatment has to start ≤6 weeks after the last chemotherapy administration. Adjuvant endocrine therapy can be initiated during or after the radiation therapy but not later than 3 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy has to be initiated ≤6 weeks after last chemotherapy administration.

- Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to inclusion:

- Hemoglobin ≥ 9 g/dL

- Absolute neutrophil count (ANC) ≥ 1500/mm3

- Platelet count ≥ 100,000/mm3

- Total bilirubin ≤ 1.5 upper limit of normal (ULN), or total bilirubin ≤ 3.0 × ULN in patients with documented Gilbert's Syndrome.

- Glomerular Filtration Rate (GFR) ≥ 30 ml/min according to Modification of Diet in Renal Disease (MDRD) formula or Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula or Cockcroft and Gault formula

- Serum Glutamic Oxaloacetic Transaminase (Aspartate Transaminase), Serum Glutamic Pyruvic Transaminase (Alanine Transaminase) and alkaline phosphatase ≤ 2.5 × ULN

- Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.

- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial

- Before patient registration/randomization, written informed consent must be obtained according to ICH/GCP, and national/local regulations.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Previous history of invasive breast cancer


- Systemic anticancer therapy prior to the breast cancer surgery


- Prior therapy with any Cyclin-Dependent Kinase (CDK)4/6 inhibitor


- Concurrent investigational agent within 28 days of randomization


- Concomitant anticancer treatment with the exception of bone antiresorptive agents or
Luteinizing Hormone-Releasing Hormone agonists in male patients treated with an
aromatase-inhibitor


- History of allergic reactions attributed to compounds of chemical or biological
composition similar to palbociclib or to chemotherapy components


- Medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes
within 7 days of randomization (see Chapter 5.6.3 for list of CYP3A inhibitors and
inducers)


- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection (including known HIV, active hepatitis B and/or hepatitis C infection),
symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac
arrhythmia, or uncontrolled diabetes.


- Other malignancy within the last 5 years except: adequately treated non-metastatic
non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal
carcinoma in situ of the breast.

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Breast Cancer Stage II, Breast Cancer Stage IIIAdjuvant Palbociclib in Elderly Patients With Breast Cancer
NCT03609047
  1. Rouen,
  2. Toulouse,
  3. Carpi,
  4. Legnago,
  5. Brussels,
  6. Brussels,
  7. Gent,
  8. Leuven,
  9. Lier,
  10. Liège,
  11. Sint-Niklaas,
  12. Turnhout,
  13. Bordeaux,
  14. Brou,
  15. Caen,
  16. La Roche-sur-Yon,
  17. Lille,
  18. Limoges,
  19. Lyon,
  20. Pierre-Bénite,
  21. Saint-Cloud,
  22. Essen,
  23. Homburg / Saar,
  24. Ravensburg,
  25. Schwerte,
  26. Stuttgart,
  27. Torgau,
  28. Witten,
  29. Biella,
  30. Bolzano,
  31. Cattolica,
  32. Faenza,
  33. Lugo,
  34. Novafeltria,
  35. Ravenna,
  36. Rimini,
  37. Torino,
  38. Amman,
  39. Gdansk,
  40. Warsaw,
  41. Barcelona,
  42. Barcelona,
  43. Barcelona,
  44. Lleida,
  45. Madrid,
  46. Madrid,
  47. Madrid,
  48. Reus,
  49. Sevilla,
  50. Sevilla,
  51. Blackpool,
  52. Edinburgh,
  53. London,
ALL GENDERS
70 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Adjuvant Palbociclib in Elderly Patients With Breast Cancer
Official Title  ICMJE A Phase II Study of Adjuvant PALbociclib as an Alternative to CHemotherapy in Elderly patientS With High-risk ER+/HER2- Early Breast Cancer
Brief Summary Phase II study to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.
Detailed Description

The primary objective of this trial is to assess the efficacy of the combination of at least 5 year endocrine therapy and 2 year-palbociclib as adjuvant systemic treatment instead of adjuvant chemotherapy followed by endocrine therapy in older patients with stage II-III ER+/HER2- early breast cancer.

This is a two-arm open-label multi-center randomized (2:1) non-comparative phase II study in elderly patients with stage II/III, ER+, HER2- early breast cancer for whom treatment with chemotherapy is indicated.

Patients will be randomized with a 2:1 allocation rate to the following treatment arm:

  • experimental palbociclib arm: Standard adjuvant endocrine therapy for a duration of at least 5 years + palbociclib for a total duration of up to 2 years.
  • control chemotherapy arm: adjuvant chemotherapy (4 cycles of docetaxel/doxorubicin/epirubicin-cyclophosphamide; or of weekly paclitaxel D1, D8, and D15 q3w if a 3 weekly schedule is not desired), followed by standard adjuvant endocrine therapy for a duration of at least 5 years.

The primary endpoint of the study is the 3-year D-RFI rate in the experimental arm.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized 2:1
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer Stage II
  • Breast Cancer Stage III
Intervention  ICMJE
  • Drug: Palbociclib
    CDK4/6 inhibitor
  • Drug: Docetaxel / cyclophosphamide
    Adjuvant Chemotherapy
  • Drug: doxorubicin/cyclophosphamide
    Adjuvant Chemotherapy
  • Drug: epirubicin/cyclophosphamide
    Adjuvant Chemotherapy
  • Drug: paclitaxel
    Adjuvant Chemotherapy
Study Arms  ICMJE
  • Experimental: experimental palbociclib arm
    Standard adjuvant endocrine therapy for a duration of at least 5 years + palbociclib (one capsule 125mg QD, orally, for 21 days followed by 7 days off treatment) for a total duration of up to 2 years.
    Intervention: Drug: Palbociclib
  • Active Comparator: control chemotherapy arm

    Adjuvant chemotherapy:

    4 cycles docetaxel 75 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles doxorubicin 60 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles epirubicin 90 mg/m2 / cyclophosphamide 600 mg/m2 q3w OR 4 cycles weekly paclitaxel 80 mg/m2 D1, D8, and D15 q3w

    Followed by standard adjuvant endocrine therapy for a duration of at least 5 years.

    Interventions:
    • Drug: Docetaxel / cyclophosphamide
    • Drug: doxorubicin/cyclophosphamide
    • Drug: epirubicin/cyclophosphamide
    • Drug: paclitaxel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 31, 2018)
366
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 13, 2031
Estimated Primary Completion Date June 13, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women or men with stage II or stage III, early invasive breast cancer according to the UICC 8th edition for TNM classification
  • Histologically confirmed Estrogen Receptor ER+ (at least 10 % of cells staining positive for ER), Human Epidermal Growth Factor Receptor 2 (HER-2) negative, early invasive breast cancer based on results of local pathology. Testing may be performed on diagnostic core biopsy or resection specimen.
  • In patients with multicentric, multifocal and/or bilateral breast cancer, all histopathologically examined invasive tumors must meet pathologic criteria regarding ER and HER2-status described above.
  • Adjuvant chemotherapy indicated and feasible according to treating physician and patient, based on standard clinicopathological parameters (tumor size, lymph node involvement, general health status, proliferation marker, patient wish) and gene expression profile if available.
  • Adjuvant chemotherapy combining both anthracycline and taxanes considered not indicated or not feasible according to treating physician.
  • No evidence of macroscopic distant metastases, investigated according to local institutional guidelines.
  • Age ?70 years
  • Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
  • Patient must have undergone breast +/- axillary surgery with curative intent for the current malignancy ?8 weeks before randomization.
  • The maximum duration from last surgery to the start of the first adjuvant treatment is 9 weeks.
  • Patients must have sufficient resolution of any surgical side effects from the last surgery per physician assessment, with no active wound healing complications at the time of randomization.
  • Incentive to undergo adjuvant radiation therapy when indicated per local institutional guidelines.
  • Note: For patients in the palbociclib arm, radiation therapy when indicated has to start ?9 weeks after last surgery. The endocrine therapy can be initiated during or after the radiation therapy but not later than 3 weeks after the last radiotherapy. Palbociclib has to start ?3 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy and palbociclib have to be initiated ?9 weeks after last surgery.
  • Note: For patients in the chemotherapy arm, chemotherapy has to be the first adjuvant treatment and has to start ?9 weeks after the last surgery. When radiation therapy is indicated, this treatment has to start ?6 weeks after the last chemotherapy administration. Adjuvant endocrine therapy can be initiated during or after the radiation therapy but not later than 3 weeks after the last radiotherapy. When radiation therapy is not indicated, endocrine therapy has to be initiated ?6 weeks after last chemotherapy administration.
  • Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to inclusion:
  • Hemoglobin ? 9 g/dL
  • Absolute neutrophil count (ANC) ? 1500/mm3
  • Platelet count ? 100,000/mm3
  • Total bilirubin ? 1.5 upper limit of normal (ULN), or total bilirubin ? 3.0 × ULN in patients with documented Gilbert's Syndrome.
  • Glomerular Filtration Rate (GFR) ? 30 ml/min according to Modification of Diet in Renal Disease (MDRD) formula or Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) formula or Cockcroft and Gault formula
  • Serum Glutamic Oxaloacetic Transaminase (Aspartate Transaminase), Serum Glutamic Pyruvic Transaminase (Alanine Transaminase) and alkaline phosphatase ? 2.5 × ULN
  • Patients must be able and willing to swallow and retain oral medication without a condition that would interfere with enteric absorption.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be obtained according to ICH/GCP, and national/local regulations.

Exclusion Criteria:

  • Previous history of invasive breast cancer
  • Systemic anticancer therapy prior to the breast cancer surgery
  • Prior therapy with any Cyclin-Dependent Kinase (CDK)4/6 inhibitor
  • Concurrent investigational agent within 28 days of randomization
  • Concomitant anticancer treatment with the exception of bone antiresorptive agents or Luteinizing Hormone-Releasing Hormone agonists in male patients treated with an aromatase-inhibitor
  • History of allergic reactions attributed to compounds of chemical or biological composition similar to palbociclib or to chemotherapy components
  • Medications or substances that are potent inhibitors or inducers of CYP3A isoenzymes within 7 days of randomization (see Chapter 5.6.3 for list of CYP3A inhibitors and inducers)
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including known HIV, active hepatitis B and/or hepatitis C infection), symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or uncontrolled diabetes.
  • Other malignancy within the last 5 years except: adequately treated non-metastatic non-melanoma skin cancer, curatively treated in situ cancer of the cervix, ductal carcinoma in situ of the breast.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 70 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: EORTC HQ+3227741611[email protected]
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Italy,   Jordan,   Poland,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03609047
Other Study ID Numbers  ICMJE EORTC 1745-ETF-BCG
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE
  • Pfizer
  • Swedish Association of Breast Oncologists
  • International Breast Cancer Study Group
  • German Adjuvant Breast Cancer Group
  • SOLTI Breast Cancer Research Group
  • UNICANCER
  • Gruppo Oncologico Italiano di Ricerca Clinica
Investigators  ICMJE
Study Chair:Hans Wildiers, MD, PhDKU Leuven
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP