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Be Part of Research - Trial Details - 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)
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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)

Not Recruiting

Open to: ALL

Age: 18.0 - N/A

London Blackpool Bath Bangor Truro Maidstone Nottingham Cleveland Rhyl Preston Swansea

Medical Conditions

Locally Advanced or Metastatic Breast Cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

Jul 2022 Oct 2027

Publications

"Kuemmel S, Harper-Wynne C, Park YH, Franke F, de Laurentiis M, Schumacher-Wulf E, Eiger D, Heeson S, Cardona A, Ozyilkan O, Morales-Vasquez F, Metcalfe C, Hafner M, Restuccia E, O'Shaughnessy J. 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 Cancer. 2024 May 24;24(1):641. doi: 10.1186/s12885-024-12179-9."; "38789924"

INTERVENTIONAL

Intervention Type : DRUG
Intervention Description : Phesgo will be administered subcutaneously (SC) at a fixed non-weight-based dose. In the induction therapy phase, a loading dose (1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase \[rHuPH20\]) will be administered in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20) will be administered once every 3 weeks (Q3W).

Intervention Arm Group : Arm A, Maintenance Therapy: Phesgo;Arm B, Maintenance Therapy: Giredestrant plus Phesgo;Induction Therapy: Phesgo plus Taxane-Based Chemotherapy;

Intervention Type : DRUG
Intervention Description : A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle.

Intervention Arm Group : Arm B, Maintenance Therapy: Giredestrant plus Phesgo;

Intervention Type : DRUG
Intervention Description : During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Docetaxel will be administered at 75 milligrams per metre squared of body surface area (mg/m2) intravenously over 60 (±10) minutes on Day 1 of each cycle for 4 to 8 cycles (a cycle is 21 days); this dose may be escalated to 100 mg/m2 if the initial dose was well tolerated.

Intervention Arm Group : Induction Therapy: Phesgo plus Taxane-Based Chemotherapy;

Intervention Type : DRUG
Intervention Description : During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Paclitaxel will be administered at 80 milligrams per metre squared of body surface area (mg/m2) intravenously over a minimum of 1 hour on Days 1, 8, and 15 of each cycle for 4 to 8 cycles (a cycle is 21 days); this weekly regimen is considered as one complete cycle whenever 3 weekly doses are given.

Intervention Arm Group : Induction Therapy: Phesgo plus Taxane-Based Chemotherapy;

Intervention Type : DRUG
Intervention Description : A luteinizing hormone-releasing hormone (LHRH) agonist will be administered every 28 days to pre- and peri-menopausal women and all male participants while receiving giredestrant in Arm B. An LHRH agonist may be administered to male participants and pre- and peri-menopausal female participants receiving tamoxifen in Arm A, and should be administered to those receiving an aromatase inhibitor in Arm A. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information.

Intervention Arm Group : Arm A, Maintenance Therapy: Phesgo;Arm B, Maintenance Therapy: Giredestrant plus Phesgo;

Intervention Type : DRUG
Intervention Description : For participants in Arm A, optional endocrine therapy of investigator's choice is allowed based on the standard of care, and it can include an aromatase inhibitor or tamoxifen with or without an LHRH agonist, or gonadal ablation. The decision to include or exclude this option must be made prior to randomization.

Intervention Arm Group : Arm A, Maintenance Therapy: Phesgo;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Charing Cross Hospital
    London
    W6 8RF
  • Blackpool Victoria Hospital
    Blackpool
    FY3 8NR
  • Royal United Hospital
    Bath
    BA1 3NG
  • Ysbyty Gwynedd Hospital
    Bangor
    LL57 2PW
  • Royal Cornwall Hospital
    Truro
    TR1 3LJ
  • Maidstone Hospital
    Maidstone
    ME16 9QQ
  • Nottingham University Hospitals NHS Trust - City Hospital
    Nottingham
    NG5 1PB
  • University Hospital North Tees
    Cleveland
    TS19 8PE
  • North Wales Cancer Treatment Centre, Glan Clwyd Hospital
    Rhyl
    LL18 5UJ
  • Royal Preston Hosp
    Preston
    PR2 9HT
  • Singleton Hospital
    Swansea
    SA2 8QA


The study is sponsored by Hoffmann-La Roche




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Read full details for Trial ID: NCT05296798
Last updated 15 January 2026

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