"Neo-Adjuvant Treatment With Palbociclib: Effect on Ki67 and Apoptosis Before, During and After Treatment "
Status:
Completed
Trial end date:
2019-11-01
Target enrollment:
Participant gender:
Summary
This is a multicenter neoadjuvant trial conducted under the sponsorship and overall trial
management of the Fondazione Michelangelo in Italy.
Women with a diagnosis of invasive unilateral non metastatic ER-positive breast cancer
expressing HER2 and suitable for neoadjuvant therapy Patients in this study will receive:
Trastuzumab+Pertuzumab+Palbociclib with or without Fulvestrant (HPPF)
Trastuzumab 8 mg/kg loading dose IV, then 6 mg/kg IV q.3 wks (repeat for a total of 6
administrations) Pertuzumab 840 mg loading dose IV, then 420 mg IV q. 3 wks (repeat for a
total of 6 administrations) Palbociclib 125 mg po q.d. x 21 q. 4 wks (= 1 cycle; repeat for a
total of 5 cycles) Fulvestrant will be given intra-muscle at the dose of 500 mg every 4 weeks
(repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose
(total administrations including the additional one = 6)
The total duration of neoadjuvant palbociclib (5 cycles every 4 weeks) and fulvestrant (5
administrations every 4 weeks plus the additional dose given two weeks after the initial
dose) was selected to match as closely as possible the total duration of the six planned
3-weekly administrations of trastuzumab and pertuzumab
Definitive surgery will be performed not earlier than 14 days and not later than 28 days
after the last dose of any of the drugs in the combination reported above
After completion of the neoadjuvant and surgical treatment patients will receive irradiation
as locally acceptable.
Patients will also continue to receive systemic drug therapy including chemotherapy (plus
standard anti-HER2 treatment until completion of full 1 year if HER2 3+ or neu amplified,
i.e. cohorts A and B) and endocrine therapy according to local guidelines at the
Investigator's discretion.