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临床试验/NL-OMON47438
NL-OMON47438招募中3 期

PALbociclib CoLlaborative Adjuvant Study: A randomized phase III trial of Palbociclib with standard adjuvant endocrine therapy versus standard adjuvant endocrine therapy alone for hormone receptor positive (HR+) / human epidermal growth factor receptor 2 (HER2)-negative early breast cancer - PALLAS

Alliance Foundation Trials (AFT) and Austrian Breast and Colorectal Cancer Study Group (ABCSG)0 个研究点目标入组 30 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
30
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • •(1) Signed informed consent obtained prior to any study specific assessments
  • •and procedures.
  • •(2) Age >=18 years (or per national guidelines).
  • •(3) Premenopausal and postmenopausal women or men with Stage II (Stage IIA
  • •limited to a max. of 1000 patients) or Stage III early invasive breast cancer
  • •per AJCC Breast Cancer Staging version 7 /UICC . Baseline staging to document
  • •absence of metastatic disease is not required, however is recommended as
  • •determined by institutional practice.
  • •(4) Patients with multicentric and/or multifocal and/or bilateral early
  • •invasive breast cancer whose histopathologically examined tumors all meet
  • •pathologic criteria for ER+ and/or PR+ and HER2-.
  • •(5) Patients must have histologically confirmed hormone receptor positive (ER+
  • •and/or PR+), HER2-, early invasive breast cancer. ER, PR and HER2 measurements
  • •should be performed acc. to institutional guidelines, in a CLIA-approved
  • •setting in the US or certified laboratories for Non-US regions. Cut-off values
  • •for positive/negative staining should be in accordance with current ASCO/CAP
  • •guidelines. Patients with equivocal HER2 in situ hybridization results
  • •according to current ASCO/CAP guidelines are eligible, as long as they have not
  • •received and are not scheduled to receive anti-HER2 treatment. Testing may
  • •occur on diagnostic core or surgical tumor tissue.
  • •(6) Patients must have undergone adequate (definitive) breast surgery for the
  • •current malignancy.
  • •(7) A formalin-fixed paraffin-embedded (FFPE) tumor tissue block must be
  • •transmitted to a central sample repository and confirmation of receipt must be
  • •available prior to randomization.
  • •(8) ECOG performance status 0-1.
  • •(9) Patients must be able and willing to swallow and retain oral medication
  • •without a condition that would interfere with enteric absorption.
  • •(10) Serum or urine pregnancy test must be negative within 7 days of
  • •randomization in women of childbearing potential. Pregnancy testing does not
  • •need to be pursued in patients who are judged as postmenopausal before
  • •randomization, as determined by local practice, or who have undergone bilateral
  • •oophorectomy, total hysterectomy, or bilateral tubal ligation. Women of
  • •childbearing potential and male patients randomized into treatment Arm A or B
  • •must use adequate contraception for the duration of protocol treatment and for
  • •6 months after the last treatment with palbociclib if they are in arm A. In
  • •addition, patients receiving standard adjuvant endocrine therapy (Arm A and Arm
  • •B) should use adequate contraception in accordance with the specific medication
  • •requirements (e.g. SmPC).Prior Treatment Specifics
  • •(11) Patients may or may not have received neo/adjuvant therapy, but must be
  • •after last dose of chemotherapy and/or biologic therapy and must have
  • •sufficient resolution of side effects per physician assessment at the time of
  • •randomization.
  • •(12) Patients may or may not have received breast/axilla/post-mastectomy chest
  • •wall radiotherapy, but must be after last dose of radiotherapy and must have
  • •sufficient resolution of side effects per physician assessment at the time of
  • •randomization.
  • •(13) 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.

排除标准

  • •(1) Concurrent therapy with other Investigational Products.
  • •(2) Prior therapy with any CDK inhibitor.
  • •(3) Patients with Stage I or IV breast cancer are not eligible. Baseline
  • •staging to document absence of metastatic disease is not required, however is
  • •recommended as determined by institutional practice.
  • •(4) History of allergic reactions attributed to compounds of chemical or
  • •biologic composition similar to palbociclib.
  • •(5) Patients receiving any medications or substances that are potent inhibitors
  • •or inducers of CYP3A isoenzymes within 7 days of randomization.
  • •(6) Uncontrolled intercurrent illness including, but not limited to, ongoing or
  • •active infection, symptomatic congestive heart failure, unstable angina
  • •pectoris, cardiac arrhythmia, diabetes, or psychiatric illness/social
  • •situations that would limit compliance with study requirements. Ability to
  • •comply with study requirements is to be assessed by each investigator at the
  • •time of screening for study participation.
  • •(7) Pregnant women, or women of childbearing potential without a negative
  • •pregnancy test (serum or urine) within 7 days prior to randomization,
  • •irrespective of the method of contraception used, are excluded from this study
  • •because the effect of palbociclib on a developing fetus is unknown.
  • •Breastfeeding must be discontinued prior to study entry.
  • •(8) Patients with a history of any malignancy are ineligible except for the
  • •following circumstances:
  • •Patients with a malignancy history other than invasive breast cancer are
  • •eligible if they have been disease-free for at least 5 years and are deemed by
  • •the investigator to be at low risk for recurrence of that malignancy.
  • •Patients with the following cancers are eligible, even if diagnosed and
  • •treated within the past 5 years: ductal carcinoma in situ of the breast,
  • •cervical cancer in situ, and non-metastatic non-melanomatous skin cancer.
  • •(9) Patients are not eligible if they have previously received endocrine
  • •therapy within 5 years prior to diagnosis of the current malignancy. This
  • •includes use for prophylactic reasons, including treatment of osteoporosis or
  • •cancer prevention with tamoxifen, raloxifene or AI. Patients may concurrently
  • •receive bisphosphonates or rank ligand inhibitors while on this study if
  • •necessary for treatment or prevention of osteopenia or osteoporosis.
  • •(10) Patients on combination antiretroviral therapy, i.e. those who are
  • •HIV-positive, are ineligible because of the potential for pharmacokinetic
  • •interactions or increased immunosuppression with palbociclib.
  • •(11) Patients with clinically significant history of chronic liver disease,
  • •including chronic / active viral or other known hepatitis, current alcohol
  • •abuse, or cirrhosis, etc.
  • •(12) Patients receiving concurrent exogenous hormone therapy (hormone
  • •replacement therapy, oral or any other hormonal contraceptives such as hormonal
  • •contraceptive coil, etc.) are not eligible but topical vaginal estrogen therapy
  • •is allowable.

研究者

发起方
Alliance Foundation Trials (AFT) and Austrian Breast and Colorectal Cancer Study Group (ABCSG)

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