Phase III study evaluating palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone-receptor-positive, HER2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy?PENELOPEB? - PENELOPE-B

German Breast GBG Forschungsgesellschaft mbH0 sites1,250 target enrollmentApril 25, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Patients with Hormone-receptor-positive / HER2 negative breast cancer and residual disease after neo-adjuvant treatment and adequate surgery.
Sponsor: German Breast GBG Forschungsgesellschaft mbH
Enrollment: 1250
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 25, 2014

End Date

December 21, 2020

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

German Breast GBG Forschungsgesellschaft mbH

Eligibility Criteria

Inclusion Criteria

•1\. Written informed consent prior to beginning specific protocol
•procedures, including expected cooperation of the patients for the
•treatment and follow\-up, must be obtained and documented according to the local regulatory requirements.
•2\. Willingness and ability to provide archived formalin fixed paraffin
•embedded tissue block or a partial block from surgery after neoadjuvant chemotherapy and from core\-biopsy before start of neoadjuvant chemotherapy, which will be used for centralized retrospective confirmation of hormone\- and HER2\-status and to evaluate correlation between genes, proteins, and mRNAs relevant to the endocrine and cell cycle pathways and sensitivity/resistance to the investigational agents.
•3\. Histologically confirmed unilateral or bilateral primary invasive
•carcinoma of the breast.
•4\. Residual invasive disease post\-neoadjuvant either in the breast or as residual nodal invasion.
•5\. Centrally confirmed hormone\-receptor\-positive (\>\=1% positive
•stained cells) and HER2\-normal (IHC score 0\-1 or FISH negative (in\-situ hybridization (ISH) ratio \<2\.0 status assessed preferably on tissue from post\-neoadjuvant residual invasive disease of the breast, or if not possible, of residual nodal invasion. In case of bilateral breast cancer status has to be confirmed for both sides.

Exclusion Criteria

•1\. Known severe hypersensitivity reactions to compounds similar to palbociclib or palbociclib/placebo excipients or to endocrine treatments.
•2\. Inadequate organ function immediate prior to randomization including: Hemoglobin \<10g/dL (100g/L) ANC \< 2,000/mm³ (\< 2\.0 x 109/L); Platelets \<100,000/mm³ (\< 100 x 109/L); AST and/or ALT \>1\.5 x upper normal limits (ULN); alkaline phosphatase \> 2\.5 x ULN, total serum bilirubin \> 1\.25 x ULN; serum creatinine \>1\.25 x ULN or estimated creatinine clearance \< 60 mL/min as calculated using the method standard for the institution; severe and
•relevant co\-morbidity that would interact with the participation in the study
•3\. Current severe or uncontrolled systemic disease
•4\. Evidence for infection including wound infections, HIV, Hepatitis
•5\. QTc \>480 msec or a family or personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
•6\. Uncontrolled electrolyte disorders that can compound the effects of a QTc prolonging drug (eg, hypocalcemia, hypokalemia, hypomagnesemia).
•7\. Any of the following within 6 months of randomization: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 4\.0 Grade ?2, atrial fibrillation of any grade, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.
•8\. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastric resection.
•9\. Prior malignancy (including invasive or ductal in\-situ breast cancer) within 5 years prior to randomization, except curatively treated basal cell carcinoma of the skin and carcinoma in situ of the cervix.