Ignite Creation Date:
2024-05-06 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05306041
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2022-03-09
Brief Title:
Neoadjuvant Endocrine Therapy - the PI3K Inhibitor Inavolisib in HER2 HR PIK3CA Mutant Early Breast Cancer
Sponsor:
German Breast Group
Organization:
German Breast Group
Study Overview
Official Title:
A Randomized Open-label Phase II Trial Comparing Neoadjuvant Endocrine Therapy in Combination With Trastuzumab Pertuzumab - the PI3K Inhibitor Inavolisib in Patients With HER2-positive HR-positive PIK3CA Mutant Early Breast Cancer-GeparPiPPa
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GeparPiPPa
Brief Summary:
Evaluation of the potential incremental efficacy and safety of inavolisib in the neoadjuvant endocrine treatment of early-stage HER2-positive HR-positive PIK3CA mutant breast cancer
Detailed Description:
This is a multicenter prospective randomized open-label parallel-group phase II study to evaluate the potential incremental efficacy and safety of inavolisib in the neoadjuvant treatment of early-stage HER2-positive HR-positive PIK3CA mutant breast cancer
170 patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 11 ratio to receive Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous PH-FDC SC formulation q3w for 6 cycles 18 weeks with 6cycles or without inavolisib Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor - GnRH analogue for premenopausal women and men
In both study arms treatment will be given until surgerycore-biopsy disease progression unacceptable toxicity or withdrawal of consent of the patient
All patients will undergo surgery or biopsy after completing study therapy to assess pCR rate
170 patients with confirmed eligibility criteria and PIK3CA mutant breast cancer will be randomized in a 11 ratio to receive Neoadjuvant endocrine therapy in combination with dual anti-HER2 blockade consisting of ready-to-use fixed-dose combination of pertuzumab and trastuzumab as subcutaneous PH-FDC SC formulation q3w for 6 cycles 18 weeks with 6cycles or without inavolisib Endocrine therapy consists of either tamoxifen 20mg or an aromatase inhibitor - GnRH analogue for premenopausal women and men
In both study arms treatment will be given until surgerycore-biopsy disease progression unacceptable toxicity or withdrawal of consent of the patient
All patients will undergo surgery or biopsy after completing study therapy to assess pCR rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None