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JOURNAL ONKOLOGIE – STUDIE
Appalaches

Adjuvant Palbociclib in Elderly Patients With Breast Cancer

Rekrutierend

NCT-Nummer:
NCT03609047

Studienbeginn:
Juni 2019

Letztes Update:
23.12.2020

Wirkstoff:
Palbociclib, Docetaxel / cyclophosphamide, doxorubicin/cyclophosphamide, epirubicin/cyclophosphamide, Paclitaxel

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Alle

Altersgruppe:
Senioren (66+)

Phase:
Phase 2

Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC

Collaborator:
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,

Studienleiter

Hans Wildiers, MD, PhD
Study Chair
KU Leuven

Kontakt

Studienlocations
(3 von 58)

Azienda Ospedaliera Citta della Salute e della Scienza di Torino - Azienda Ospedaliera Città della Salute e della Scienza di Torino - Ospedale Sant'Anna
Torino
ItalyRekrutierend» Google-Maps
Ansprechpartner:
Maria Grazia Bau» Ansprechpartner anzeigen
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska - Curie's National Institute of Oncology - National Research Institute
Warsaw
PolandRekrutierend» Google-Maps
Ansprechpartner:
Zbigniew Nowecki» Ansprechpartner anzeigen
Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. distant recurrence-free interval (D-RFI) rate (Time Frame - 5 years after first patient inclusion)



Secondary outcome:

1. Breast cancer specific survival (Time Frame - 5 years after first patient inclusion)

2. Overall survival (Time Frame - 5 years after first patient inclusion)

3. Incidence of permanent treatment discontinuation (Time Frame - 5 years after first patient inclusion)

Studien-Arme

  • 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.
  • 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.

Geprüfte Regime

  • Palbociclib:
    CDK4/6 inhibitor
  • Docetaxel / cyclophosphamide:
    Adjuvant Chemotherapy
  • doxorubicin/cyclophosphamide:
    Adjuvant Chemotherapy
  • epirubicin/cyclophosphamide:
    Adjuvant Chemotherapy
  • paclitaxel:
    Adjuvant Chemotherapy

Quelle: ClinicalTrials.gov


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