Ignite Creation Date:
2024-05-06 @ 2:13 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04253561
Status:
RECRUITING
Last Update Posted:
2023-04-18
First Post:
2020-01-17
Brief Title:
Ipatasertib Pertuzumab Trastuzumab in Advanced HER2 PI3KCA-mutant Breast Cancer Patients
Sponsor:
SOLTI Breast Cancer Research Group
Organization:
SOLTI Breast Cancer Research Group
Study Overview
Official Title:
A Phase Ib Study of Ipatasertib an AKT Inhibitor in Combination With Pertuzumab Plus Trastuzumab in Patients With PI3KCA-mutant HER2-positive Locally Advanced or Metastatic Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-04
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:
IPATHER
Brief Summary:
This is an open label single arm multicenter phase Ib study to evaluate the safety and clinical activity of the combination of ipatasertib trastuzumab and pertuzumab in patients with unresectable locally advanced or metastatic HER2-positive breast cancer with tumors harboring PIK3CA mutations candidates to receive maintenance HP after first line treatment for metastatic disease with a taxane plus HP
Detailed Description:
The main objective of the study is to assess whether the combination of ipatasertib and HP - ET is tolerable especially in terms of the incidence and severity of diarrhea For this purpose up to a total of 25 patients will be enrolled in a staggered manner and evaluated
A 3-cohort descending doses 400 300 200 mg design will serve to establish the Maximun Toleraded Dose MTD and Recommended Phase 2 Dose RP2D of ipatasertib in combination with HP
The study will initially include 6 patients that will receive ipatasertib plus HP at Dose Level 1
If 1 DLTs are observed this dose will be deemed safe and the trial will enroll at least additional 19 patients to further assess safety and preliminary efficacy of the combination
If 2 DLT occurs in the first 6 patients a decision will be made of whether expand Dose Level 1 to 10 additional patients or to de-escalate ipatasertib to the next lower dose level In the case of de-escalation the same rules will apply for enrollment and expansion of Dose level -1 The minimum ipatasertib dose explored will be Dose level -2
Dose reductions of pertuzumab and trastuzumab will not be allowed
If all inclusion criteria and no exclusion criteria are met patients will be enrolled in the trial and will start treatment with oral PO ipatasertib once a day QD D1-21 in 28-days cycles together with pertuzumab 420 mg intravenous IV every 21 days Q21d and trastuzumab 600 mg subcutaneous SC Q21d
Patients with hormone receptor positive HR tumors defined as ER andor PgR expression in 1 of tumor cells will also receive endocrine therapy either an Aromatase Inhibitor AI tamoxifen or fulvestrant - Luteinizing Hormone-Releasing Hormone LHRH analogues according to Investigators decision
Patients will also start loperamide 2 mg twice a day BID or 4 mg QD as prophylaxis for diarrhea in the first cycle
A 3-cohort descending doses 400 300 200 mg design will serve to establish the Maximun Toleraded Dose MTD and Recommended Phase 2 Dose RP2D of ipatasertib in combination with HP
The study will initially include 6 patients that will receive ipatasertib plus HP at Dose Level 1
If 1 DLTs are observed this dose will be deemed safe and the trial will enroll at least additional 19 patients to further assess safety and preliminary efficacy of the combination
If 2 DLT occurs in the first 6 patients a decision will be made of whether expand Dose Level 1 to 10 additional patients or to de-escalate ipatasertib to the next lower dose level In the case of de-escalation the same rules will apply for enrollment and expansion of Dose level -1 The minimum ipatasertib dose explored will be Dose level -2
Dose reductions of pertuzumab and trastuzumab will not be allowed
If all inclusion criteria and no exclusion criteria are met patients will be enrolled in the trial and will start treatment with oral PO ipatasertib once a day QD D1-21 in 28-days cycles together with pertuzumab 420 mg intravenous IV every 21 days Q21d and trastuzumab 600 mg subcutaneous SC Q21d
Patients with hormone receptor positive HR tumors defined as ER andor PgR expression in 1 of tumor cells will also receive endocrine therapy either an Aromatase Inhibitor AI tamoxifen or fulvestrant - Luteinizing Hormone-Releasing Hormone LHRH analogues according to Investigators decision
Patients will also start loperamide 2 mg twice a day BID or 4 mg QD as prophylaxis for diarrhea in the first cycle
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-001526-94 | EUDRACT_NUMBER | None | None |