Adjuvant Palbociclib in Elderly Patients With Breast Cancer
NCT03609047
ABOUT THIS STUDY
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- 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.
- 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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Descriptive Information | |||||||
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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:
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 |
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Intervention ICMJE |
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Study Arms ICMJE |
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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 | 366 | ||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||
Estimated Study Completion Date ICMJE | June 13, 2032 | ||||||
Estimated Primary Completion Date | June 13, 2025 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 70 Years and older (Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Belgium, France, Germany, Italy, Jordan, Poland, Portugal, 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 |
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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 |
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Investigators ICMJE |
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PRS Account | European Organisation for Research and Treatment of Cancer - EORTC | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |