Ignite Creation Date:
2024-05-06 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04733118
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-13
First Post:
2020-12-04
Brief Title:
Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
Chemotherapy-Free pCR-Guided Strategy With Subcutaneous Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer PHERGAIN-2
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-02
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:
PHERGAIN-2
Brief Summary:
This is a multicenter open-label single-arm one-stage phase II study to assess the efficacy of a chemotherapy-free pathological complete response pCR-guided strategy with trastuzumab and pertuzumab given as a subcutaneous fixed-dose combination and T-DM1 for patients with previously untreated HER2-positive early breast cancer
Detailed Description:
Patients 18 years of age with previously untreated HER2 IHC 3 invasive carcinoma according to ASCOCAP 2018 guidelines
Tumor size between 5 to 30 mm by breast MRI and node-negative status by clinical exam MRI and ultrasound In patients with suspected axillary node involvement a negative fine needle aspiration biopsy FNAB will be mandatory
Central review for
Breast MRI HER2 status Neoadjuvant treatment will consist In 8 cycles of fixed-dose subcutaneous SC FDC HP combination ET according to HR status
urgery will be performed within 4 weeks from the last cycle of HP sentinel node biopsy will be mandatory subsequent axillary dissection will be performed according to local guidelines Surgery will require free margins for any infiltrating or DCIS lesion
Radiotherapy will be mandatory for patients with breast preservation
Adjuvant systemic therapy will be started within 4 weeks from surgery depending on pathological report
Arm A pCR breast and axilla HP SC FDC x 10 cycles Arm B Residual invasive breast tumor andor ypN0i ypN0mol ypN1mi T-DM1 x 10 cycles Arm C ypN1 to N3 T-DM1 x 10 cycles with physicians choice chemotherapy allowed between surgery and T-DM1
All patients with HR tumors will receive adjuvant ET up to at least 5 years ET will also be administered in association with adjuvant HP or T-DM1 with the exception of the cycles involving the use of chemotherapy in Arm C
Tumor size between 5 to 30 mm by breast MRI and node-negative status by clinical exam MRI and ultrasound In patients with suspected axillary node involvement a negative fine needle aspiration biopsy FNAB will be mandatory
Central review for
Breast MRI HER2 status Neoadjuvant treatment will consist In 8 cycles of fixed-dose subcutaneous SC FDC HP combination ET according to HR status
urgery will be performed within 4 weeks from the last cycle of HP sentinel node biopsy will be mandatory subsequent axillary dissection will be performed according to local guidelines Surgery will require free margins for any infiltrating or DCIS lesion
Radiotherapy will be mandatory for patients with breast preservation
Adjuvant systemic therapy will be started within 4 weeks from surgery depending on pathological report
Arm A pCR breast and axilla HP SC FDC x 10 cycles Arm B Residual invasive breast tumor andor ypN0i ypN0mol ypN1mi T-DM1 x 10 cycles Arm C ypN1 to N3 T-DM1 x 10 cycles with physicians choice chemotherapy allowed between surgery and T-DM1
All patients with HR tumors will receive adjuvant ET up to at least 5 years ET will also be administered in association with adjuvant HP or T-DM1 with the exception of the cycles involving the use of chemotherapy in Arm C
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?:
False
Is an FDA AA801 Violation?:
None