A Phase 2 interventional study of Trastuzumab and Pertuzumab in Breast Neoplasms, sponsored by Fondazione Michelangelo. Completed at 7 sites in Italy. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.
Sponsored by Fondazione Michelangelo · Phase 2, Interventional, and Other
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.
This is a multicenter neoadjuvant trial conducted under the sponsorship and overall trial management of the Fondazione Michelangelo in Italy.
Three cohorts of patients are planned
Patients with ER positive tumors (> 10%) and HER2 3+ or neu amplified Cohort A Trastuzumab+Pertuzumab+Palbociclib+Fulvestrant (HPPF)
Cohort B Trastuzumab+Pertuzumab+Palbociclib (HPP) Allocation to Cohort B will be started after recruitment to Cohort A has been completed
Patients with ER positive tumors (> 10%), PgR positive, HER2 1+/2+ (without amplification) and Ki67 > 20% Cohort C Trastuzumab+Pertuzumab+Palbociclib+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.
Primary objectives:
Secondary objectives:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 102 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fondazione Michelangelo is the lead sponsor of 9 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive an association of drugs (trastuzumab, pertuzumab, palbociclib plus or minus fulvestrant) as neoadjuvant chemotherapy. 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. After completion of surgical treatment patients will receive irradiation as locally acceptable.
Drug: Trastuzumab · Drug: Pertuzumab · Drug: Palbociclib · Drug: Fulvestrant
Trastuzumab (8 mg/kg loading dose IV, then 6 mg/kg IV) will be given on day 1 q. 3 weeks for a total of 6 administrations
Also known as: Herceptin
Pertuzumab (840 mg as an i.v. infusion) will be given on day 1 q. 3 weeks for a total of 6 administration
Also known as: Perjeta
Palbociclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks (i.e. 1 week rest period for a total of 5 cycles
Also known as: Ibrabce
Fulvestrant will be administered according to local prescription guidelines and 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
Also known as: Faslodex
Serial measures of Ki67
Changes in Ki67 scores from baseline before therapy, 2 weeks after and then at surgery
Time frame: Participants will be followed for the duration of protocol therapy, an expected average of 26 weeks
Serial measures of apoptosis
Changes in apoptosis biomarker scores from baseline before therapy and at surgery
Time frame: Participants will be followed for the duration of protocol therapy, an expected average of 26 weeks
pathological complete response (pCR)
Assess the rate of pathological complete response (pCR) defined as ypT0-ypTis ypN0 at surgery
Time frame: at surgery
clinical objective response
Assess the clinical objective response rate after medical therapy
Time frame: Participants will be followed for the duration of medical therapy, an expected average of 24 weeks
Number of participants with adverse events as a Measure of Safety and Tolerability
Number of participants with Adverse Events and related grade
Time frame: Participants will be followed for up to 7 months
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Fondazione Michelangelo