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Phesgo

DRUG7 trials

Sponsors

F. Hoffmann-La Roche Ltd, Hoffmann-La Roche, GBG Forschungs GmbH, Latin American Cooperative Oncology Group, Dana-Farber Cancer Institute

Conditions

Breast CancerBreast Cancer FemaleBreast Cancer MetastaticCancerEstrogen Receptor-positive Breast CancerHER2-positive Breast CancerLocally Advanced or Metastatic Breast CancerMetastatic Breast Cancer

Phase 2

Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer
RecruitingNCT05306041
GBG Forschungs GmbHHER2-positive Breast Cancer
Start: 2023-01-02End: 2027-03-01Target: 170Updated: 2026-09-11
Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients With HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade
Active, not recruitingNCT06068985
Latin American Cooperative Oncology GroupBreast Cancer, HER2-positive Breast Cancer
Start: 2024-09-05End: 2032-11-01Target: 63Updated: 2026-08-28
The SAPPHO Study: Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer
RecruitingNCT06439693
Dana-Farber Cancer InstituteBreast Cancer, Breast Cancer Female, Breast Cancer Metastatic +3
Start: 2024-08-08End: 2033-03-30Target: 72Updated: 2026-08-06
Assessing the efficacy and safety of optimal neoadjuvant to adjuvant anti-HER2- based therapy in Nigerian women with HER2+ Breast Cancer
Active, not recruitingPACTR202406683851265
University of ChicagoCancer
Start: 2024-08-01Target: 74Updated: 2026-09-14

Phase 3

A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
Active, not recruitingNCT05296798
Hoffmann-La RocheLocally Advanced or Metastatic Breast Cancer
Start: 2022-07-18End: 2030-12-31Target: 922Updated: 2026-07-16
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
RecruitingNCT05894239
Hoffmann-La RocheMetastatic Breast Cancer
Start: 2023-09-08End: 2032-12-28Target: 230Updated: 2026-08-25
A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF GIREDESTRANT IN COMBINATION WITH PHESGO VERSUS PHESGO AFTER INDUCTION THERAPY WITH PHESGO?TAXANE IN PATIENTS WITH PREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTOR-POSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER
RecruitingLBCTR2024015502
F. Hoffmann-La Roche LtdPREVIOUSLY UNTREATED HER2-POSITIVE, ESTROGEN RECEPTORPOSITIVE LOCALLY-ADVANCED OR METASTATIC BREAST CANCER Breast Cancer
Start: 2022-07-18Target: 922Updated: 2026-02-02

Related Papers

Abstract P2-10-30: Classifying for HER2 Dependence to De-Escalate Neoadjuvant Chemotherapy in Patients with HER2+ Early Breast Cancer Undergoing HER2 Double-Blockade - CHERRY-PICK Trial (LACOG 0721)
Clinical Cancer Research2025-06-13
Safety overview and management of inavolisib alone and in combination therapies in PIK3CA-mutated, HR-positive, HER2-negative advanced breast cancer (GO39374).
2025-06-121 citations
INAVO122: A phase III study of maintenance inavolisib or placebo + pertuzumab + trastuzumab following induction with pertuzumab + trastuzumab + a taxane in patients (pts) with <i>PIK3CA</i>-mutated, HER2-positive advanced breast cancer (HER2+ aBC).
Journal of Clinical Oncology2024-06-014 citations
heredERA Breast Cancer: a phase III, randomized, open-label study evaluating the efficacy and safety of giredestrant plus the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection in patients with previously untreated HER2-positive, estrogen receptor-positive locally advanced or metastatic breast cancer
BMC Cancer2024-05-246 citations
Abstract PO2-19-09: INAVO122: a Phase III study of maintenance inavolisib or placebo + pertuzumab + trastuzumab following induction with pertuzumab + trastuzumab + a taxane in patients with PIK3CA-mutated, HER2-positive advanced breast cancer
Cancer Research2024-05-021 citations
Abstract OT2-03-01: heredERA Breast Cancer: Phase III study of first-line, fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection ± giredestrant (GDC-9545) for estrogen receptor+, HER2+ advanced breast cancer
Cancer Research2023-03-013 citations