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)

StatusActive, Not Recruiting

PhasePhase 3

SponsorHoffmann-La Roche

Started2022-07-18

View on ClinicalTrials.gov ↗

Trial flagged as At Risk

Primary completion moved at least 2 months later Oct 31, 2027 → Dec 31, 2027

See other at-risk trials from Roche/Genentech

Amendment history

The 49 most recent of 53 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-09-30

Trial sites reduced: 202 → 198 locations

Primary completion pushed: 2027-10-31 → 2027-12-31

2026-07-15

Study Status, Contacts/Locations v52

Trial sites reduced: 206 → 202 locations

2026-04-15

Study Status, Contacts/Locations v51

Study sites208→206

2026-01-15

Study Status, Contacts/Locations v50

Study sites209→208

2025-10-17

Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v49

Trial statusRecruiting→Active, Not Recruiting

Primary completion date2027-12-31→2027-10-31

Study sites237→209

Show 45 earlier versions

2025-10-15

Study Status v48

Re-verified, no change to tracked fields

2025-09-15

Study Status, Contacts/Locations v47

Study sitesdetails revised at 10 of 237 sites

2025-08-19

Study Status, Contacts/Locations v46

Study sitesdetails revised at 2 of 237 sites

2025-07-22

Study Status, Contacts/Locations v45

Study sitesdetails revised at 5 of 237 sites

2025-06-24

Study Status, Contacts/Locations v44

Study sitesdetails revised at 17 of 237 sites

2025-05-26

Study Status, Contacts/Locations v43

Study sitesdetails revised at 1 of 237 sites

2025-04-25

Study Status, Contacts/Locations v42

Study sitesdetails revised at 26 of 237 sites

2025-03-27

Study Status, Contacts/Locations v41

Study sitesdetails revised at 1 of 237 sites

2025-02-28

Study Status, Contacts/Locations v40

Primary completion date2027-03-31→2027-12-31

Start date2022-07-04→2022-07-18

Study sites233→237

2025-01-31

Study Status, Study Design, Outcome Measures, Eligibility v39

Enrollment target812→922

Eligibility criteria+162 characters

[...] Phase Inclusion Criteria Complete a minimum of four cycles to a maximum of eight cycles of induction therapy; the minimum cycles are defined as either: Phesgo injections + 4 docetaxel infusions, or Phesgo injections + 12 paclitaxel infusions Achieve a minimum of stable disease (SD) (or Non-complete r [...]

Secondary endpointsdetails revised at 12 of 12 entries

2025-01-10

Study Status, Contacts/Locations v38

Study sites230→233

2024-12-12

Study Status v37

Primary completion date2026-08-31→2027-03-31

Completion date2032-09-30→2030-12-31

2024-11-14

Study Status v36

Re-verified, no change to tracked fields

2024-10-15

Study Status, Contacts/Locations v35

Study sitesdetails revised at 8 of 230 sites

2024-09-18

Study Status, Contacts/Locations v34

Study sites224→230

2024-08-19

Study Status, Contacts/Locations v33

Study sites219→224

2024-07-22

Study Status, Contacts/Locations v32

Study sites215→219

2024-06-24

Study Status, Contacts/Locations, IPDSharing v31

Study sites212→215

2024-05-27

Study Status, Contacts/Locations v30

Study sites206→212

2024-04-29

Study Status, Contacts/Locations v29

Study sites199→206

2024-04-03

Study Status, Contacts/Locations v28

Study sites197→199

2024-03-08

Study Status, Contacts/Locations v27

Study sites196→197

2024-02-12

Study Status, Contacts/Locations v26

Study sites192→196

2024-01-15

Study Status, Contacts/Locations v25

Study sites189→192

2023-12-19

Study Status, Contacts/Locations v24

Study sites188→189

2023-11-27

Study Status, Contacts/Locations v23

Study sites185→188

2023-10-30

Study Status, Contacts/Locations v22

Study sites182→185

2023-10-03

Study Status, Contacts/Locations v21

Study sites180→182

2023-09-04

Study Status, Contacts/Locations v20

Study sites178→180

2023-08-09

Study Status, Eligibility, Contacts/Locations, IPDSharing v19

Study sites177→178

Eligibility criteria+444 characters

[...] nt setting Disease progression within 6 months of receiving adjuvant anti-HER2 therapy (such as trastuzumab, with or without pertuzumab [IV, SC, or fixed-dose combination], or ado-trastuzumab emtansine, inor ~~the adjuvant setting~~neratinib) Non-resolution of all acute toxic effects of prior anti-can [...] the study or within 7 months after the final dose of Phesgo (Women of childbearing potential must have a negative serum p [...] sult within 14 days prior to initiation of induction therapy). Treated with investigational therapy within 28 days prior t [...] ension Known clinically significant history of liver disea [...]

2023-07-25

Study Status, Contacts/Locations v18

Study sites173→177

2023-06-27

Study Status, Contacts/Locations v17

Study sites169→173

2023-05-30

Study Status, Contacts/Locations v16

Study sites166→169

2023-05-03

Study Status, Contacts/Locations v15

Study sites165→166

2023-04-05

Study Status, Contacts/Locations v14

Study sites162→165

2023-03-09

Study Status, Contacts/Locations v13

Study sites151→162

2023-02-13

Study Status, Contacts/Locations v12

Study sites138→151

2023-01-16

Study Status, Outcome Measures, Eligibility, Contacts/Locations v11

Study sites119→138

Eligibility criteria+225 characters

[...] b SC with pertuzumab IV, or pertuzumab and trastuzumab IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the n [...] eligible provided they are stable on anti-retroviral therapy for ≥4 weeks, have a CD4 count ≥~~200~~350 cells/uL, and have an undetectable viral load and no histor [...] endocrine therapy that requires gonadal function suppression Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of giredestrant treatment in Arm B

Secondary endpointsdetails revised at 6 of 12 entries

2022-12-16

Study Status, Contacts/Locations v10

Study sites103→119

2022-11-24

Study Status, Contacts/Locations v9

Study sites92→103

2022-10-28

Study Status, Contacts/Locations v8

Study sites80→92

2022-10-17

Study Status, Contacts/Locations v7

Study sites61→80

2022-09-20

Study Status, Contacts/Locations v6

Study sites53→61

2022-08-23

Study Status, Contacts/Locations v5

Start date2022-07-18→2022-07-04

Study sites22→53

2022-07-25

Study Status, Contacts/Locations v4

Start dateestimated 2022-06-30→confirmed 2022-07-18

Study sites4→22

Roche/Genentech

364 trials monitored

See 34 trials at risk

Breast Cancer

5,180 trials monitored

See 256 trials at risk

This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human epidermal growth factor receptor 2 (HER2)-positive, estrogen receptor (ER)-positive advanced breast cancer (metastatic or locally advanced disease not amenable to curative treatment) who have not previously received a systemic non-hormonal anti-cancer therapy in the advanced setting.

Trial Details

NCT Number	NCT05296798
Lead Sponsor	Hoffmann-La Roche
Conditions	Locally Advanced or Metastatic Breast Cancer
Enrollment	922 participants
Start Date	2022-07-18
Primary Completion	2027-12-31 (estimated)
Study Completion	2030-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-09-29