NL-OMON47438
Recruiting
Phase 3
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 sites30 target enrollmentStarted: TBDLast updated:
Overview
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Alliance Foundation Trials (AFT) and Austrian Breast and Colorectal Cancer Study Group (ABCSG)
- Enrollment
- 30
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •(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
Exclusion Criteria
- •(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
Investigators
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