Ignite Creation Date:
2025-12-24 @ 12:07 PM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT04253561
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2020-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ipatasertib + Pertuzumab +Trastuzumab in Advanced HER2+ PI3KCA-mutant Breast Cancer Patients
Sponsor:
SOLTI Breast Cancer Research Group
Organization:
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:
UNKNOWN
Status Verified Date:
2023-04
Last Known Status:
RECRUITING
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 and/or 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 Investigator's 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 and/or 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 Investigator's 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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019-001526-94 | EUDRACT_NUMBER | None | View |