RWF_B-54-I Penelope

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 'PENELOPE-B'

The PENELOPE-B 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.

Key Eligibility:

* Histologically confirmed unilateral or bilateral primary invasive carcinoma of the breast.

* Residual invasive disease post-neoadjuvant either in the breast or as residual nodal invasion.

* Centrally confirmed hormone-receptor-positive ( greater than or equal to 1% ER and/or PR 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 or core biopsy 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.

* Patients must have received neoadjuvant chemotherapy of at least 16 weeks.
Phase III
NCT01864746
Oncology
Breast
Alison Conlin, M.D.
GBG Forschungs GmbH
Nikki Moxon
  • Oncology and Hematology Care Eastside
  • Oncology and Hematology Care Newberg
  • Oncology and Hematology Care Southeast
  • Oncology and Hematology Care Westside