PENELOPE-B : 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.

Female<br/>OnlyGender Female
Only

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18-75Age 18-75

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy | BreastBreast,

Trial Overview Read MoreRead more

This phase III trial is trying to demonstrate the effect of using palbociclib (a prescribed drug) in combination with anti-hormonal therapy for patients with hormone receptor positive / HER2 normal breast cancer.
 

This trial is treating patients with hormone receptor positive / HER2 normal breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have had a certain type of treatment or surgical procedure.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

  • NCT01864746
  • GBG78/BIG 1-13/NSABP-B-54-I, 2013-001040-62, ANZ 1402, NC100

Scientific Title

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.

Cooperative Group

German Breast Group

Summary

About one third of patients with hormone-receptor (HR)-positive, HER2-normal breast cancer and residual disease after neoadjuvant chemotherapy have a substantial risk of relapse. The clinical-pathologic stage - estrogen/grade (CPS-EG) combining clinical stage before neoadjuvant treatment, pathological stage after neoadjuvant treatment, grading and estrogen-receptor status can be used to identify these high-risk patients. The CPS-EG score was additionally validated in 2453 patients with HR-positive/HER2-normal tumors from the German neoadjuvant studies' meta-database. 24% of these patients had a score of 3 or higher and showed a 3-years DFS of 74% despite adequate local therapy and adjuvant endocrine treatment. Cyclin dependent kinases (CDK), a group of serine/threonine kinases, play a key role in regulating cell cycle progression by interacting with specific cyclin proteins in luminal-type tumors. , PD-0332991 (palbociclib) is an oral, highly selective inhibitor of CDK4/6 kinase activity that prevents cellular DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase through blocking retinoblastoma (Rb) phosphorylation. Preclinical studies identified luminal ER subtype, elevated expression of cyclin D1 and Rb protein, and reduced p16 expression as being associated with sensitivity to palbociclib. The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

Recruiting Hospitals Read MoreRead more

Ballarat Oncology & Haematology
Ballarat
Ms Rosemary Cotton
rosemaryc@ballaratoncology.com.au
03 5339 8000

Cabrini Education and Research Precinct
Malvern
Dr Emma Baker
ebaker@cabrini.com.au
(03) 9508 3493

Barwon Health, University Hospital Geelong
Geelong
Dr Lea-Anne Harrison
leaanne.harrison@barwonhealth.org.au
03 42 15 2758

Maroondah Hospital, Maroondah Breast Clinic
Ringwood East
Ms Krystine Walsh
krystine.walsh@easternhealth.org.au
03 9871 3585

Victorian Breast and Oncology Care
East Melbourne
Ms Kayte Robinson
kayte@vboc.com.au
03 9417 4666

Monash Medical Centre, Medical Oncology
Clayton
Ms Irina Arzhintar
Irina.Arzhintar@monashhealth.org
03 8572 2018

Not Recruiting Hospitals Read MoreRead more

Closed

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167