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)

NCT ID: NCT05296798

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

922 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Locally Advanced or Metastatic Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Induction Therapy: Phesgo plus Taxane-Based Chemotherapy

Group Type OTHER

Phesgo

Intervention Type DRUG

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).

Docetaxel

Intervention Type DRUG

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.

Paclitaxel

Intervention Type DRUG

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.

Arm A, Maintenance Therapy: Phesgo

Group Type ACTIVE_COMPARATOR

Phesgo

Intervention Type DRUG

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).

LHRH Agonist

Intervention Type DRUG

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.

Optional Endocrine Therapy of Investigator's Choice

Intervention Type DRUG

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.

Arm B, Maintenance Therapy: Giredestrant plus Phesgo

Group Type EXPERIMENTAL

Phesgo

Intervention Type DRUG

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).

Giredestrant

Intervention Type DRUG

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

LHRH Agonist

Intervention Type DRUG

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.

Interventions

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Phesgo

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 Type DRUG

Giredestrant

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 Type DRUG

Docetaxel

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 Type DRUG

Paclitaxel

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 Type DRUG

LHRH Agonist

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 Type DRUG

Optional Endocrine Therapy of Investigator's Choice

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 Type DRUG

Other Intervention Names

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Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Pertuzumab, Trastuzumab, and rHuPH20 Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) RO7198574 RG6264 GDC-9545 RO7197597 RG6171

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection
* At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence of ≥6 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
* Left ventricular ejection fraction (LVEF) of at least (≥)50% measured by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA)
* Adequate hematologic and end-organ function
* For women of childbearing potential: Participants who agree to remain abstinent (refrain from heterosexual intercourse) or use contraception, and agree to refrain from donating eggs, during the treatment period and for 7 months after the final dose of Phesgo
* For men: participants who agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm, during the treatment period and for 7 months after the final dose of Phesgo to avoid exposing the embryo


* 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 response \[CR\]/Non-progressive disease \[PD\] for participants with non-measurable disease) (i.e., did not experience PD) according to RECIST v1.1 at the last tumor assessment during the induction therapy phase
* LVEF of ≥50% at the last assessment during the induction therapy phase

Exclusion Criteria

* Previous systemic non-hormonal anti-cancer therapy in the metastatic breast cancer (MBC) or advanced breast cancer (ABC) setting. Note: Up to one line of single-agent endocrine therapy given in the metastatic or locally advanced setting will be allowed.
* Prior treatment with a selective estrogen receptor degrader (SERD)
* Previous treatment with approved or investigative anti-HER2 agents in any breast cancer treatment setting, except Phesgo (or trastuzumab SC with pertuzumab IV, or pertuzumab and trastuzumab IV), single-agent trastuzumab IV or SC, ado-trastuzumab emtansine, lapatinib, and neratinib in the neoadjuvant or adjuvant 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, or neratinib)
* Non-resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) Grade 1 or better
* History of persistent Grade ≥2 (NCI-CTC, Version 5.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy
* History of exposure to the following cumulative doses of anthracyclines; Doxorubicin \>360 mg/m2; Liposomal doxorubicin \>500 mg/m2; Epirubucin \>720 mg/m2; Mitoxantrone \>120 mg/m2; Idarubicin \>90 mg/m2.
* Known active uncontrolled or symptomatic central nervous system (CNS) metastases, carcinomatous meningitis, or leptomeningeal disease
* Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy
* Pregnant or breastfeeding, or intending to become pregnant during the study or within 7 months after the final dose of Phesgo (Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of induction therapy).
* Treated with investigational therapy within 28 days prior to initiation of induction therapy
* Treated with localized palliative radiotherapy within 14 days prior to initiation of induction therapy
* Concurrent participation in any other therapeutic clinical trial
* Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies
* Current chronic daily treatment (continuous for \>3 months) with corticosteroids (dose of 10 mg/day methylprednisolone or equivalent)
* Poorly controlled hypertension
* Known clinically significant history of liver disease consistent with Child-Pugh Class B or C, active liver disease including active viral or other hepatitis virus, autoimmune hepatic disorders, or sclerosing cholangitis, current alcohol abuse, or cirrhosis
* Active cardiac disease or history of cardiac dysfunction
* Major surgical procedure or significant traumatic injury within 14 days prior to enrollment or anticipation of need for major surgery during induction therapy
* Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or major upper gastrointestinal surgery
* Concurrent, serious, uncontrolled infections, or known infection with HIV with the following exception: Individuals who are HIV positive are eligible provided they are stable on anti-retroviral therapy for ≥4 weeks, have a CD4 count ≥350 cells/uL, and have an undetectable viral load and no history of AIDS-defining opportunistic infections within 12 months prior to enrollment.
* Serious COVID-19 infection within 14 days prior to enrollment; however, no screening testing for SARS-CoV-2 is required
* Serious infection requiring oral or IV antibiotics within 7 days prior to screening
* Any serious medical condition or abnormality in clinical laboratory tests that precludes an individual's safe participation in the study
* History of malignancy within 5 years prior to screening with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death
* For pre- and perimenopausal women, and men: Known hypersensitivity to luteinizing hormone-releasing hormone agonist (LHRHa); Not willing to undergo and maintain treatment with approved LHRHa therapy for the duration of 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
* A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism, including deep vein thrombosis, unless the condition is adequately treated and under control
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Arizona Clinical Research Center, Inc

Tucson, Arizona, United States

Site Status

Los Angeles Hematology Oncology Medical Group

Los Angeles, California, United States

Site Status

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

Maryland Oncology Hematology - Annapolis

Annapolis, Maryland, United States

Site Status

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

St. Joseph Mercy Oakland

Pontiac, Michigan, United States

Site Status

Queens Hospital Cancer Center

Jamaica, New York, United States

Site Status

Clinical Research Alliance

Westbury, New York, United States

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West Cancer Center

Germantown, Tennessee, United States

Site Status

CHRISTUS Spohn Cancer Center - Shoreline

Corpus Christi, Texas, United States

Site Status

Texas Oncology - DFW

Dallas, Texas, United States

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Texas Oncology - El Paso

El Paso, Texas, United States

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CHRISTUS St. Michael Health System

Texarkana, Texas, United States

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Swedish Cancer Institute - Edmonds Campus

Edmonds, Washington, United States

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Swedish Cancer Institute - Issaquah

Issaquah, Washington, United States

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Swedish Cancer Institute

Seattle, Washington, United States

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Centro de Investigaciones Médicas y Desarrollo LC S.R.L

Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina

Site Status

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

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Fundacion Centro Oncologico de Integracion Regional (COIR)

Mendoza, , Argentina

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Instituto de Oncología de Rosario

Rosario, , Argentina

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Hospital Provincial del Centenario

Rosario, , Argentina

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CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica

San Juan, , Argentina

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GHdC Site Les Viviers

Charleroi, , Belgium

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UZ Gent

Ghent, , Belgium

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Jessa Zkh (Campus Virga Jesse)

Hasselt, , Belgium

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UZ Leuven Gasthuisberg

Leuven, , Belgium

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Clinique Ste-Elisabeth

Namur, , Belgium

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Pronutrir - suporte nutricional e quimioterapia ltda.

Fortaleza, Ceará, Brazil

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Hospital Sao Rafael - HSR

Salvador, Estado de Bahia, Brazil

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Hospital Araujo Jorge

Goiânia, Goiás, Brazil

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Hospital do Câncer de Londrina

Londrina, Paraná, Brazil

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Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, Brazil

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Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

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Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

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Hospital de Amor Amazônia

Porto Velho, Rondônia, Brazil

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Fundação Pio XII Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

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Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, Brazil

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Affiliated Hospital of Hebei University

Baoding, , China

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Peking University People's Hospital

Beijing, , China

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the First Affiliated Hospital of Bengbu Medical College

Bengbu, , China

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The First Hospital of Jilin University

Changchun, , China

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Hunan Cancer Hospital

Changsha, , China

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Sichuan Cancer Hospital

Chengdu, , China

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West China Hospital - Sichuan University

Chengdu, , China

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No. 900 Hospital (Fuzhou General Hospital)

Fuzhou, , China

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Fujian Cancer Hospital

Fuzhou, , China

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Zhejiang Provincial People?s Hospital

Hangzhou, , China

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Zhejiang Cancer Hospital

Hangzhou, , China

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Shandong Cancer Hospital

Jinan, , China

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The First Affiliated Hospital Of Jinzhou Medical University

Jinzhou, , China

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Yunnan Cancer Hospital

Kunming, , China

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Jiangxi Cancer Hospital

Nanchang, , China

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Jiangsu Cancer Hospital

Nanjing, , China

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Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)

Nanjing, , China

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Guangxi Cancer Hospital of Guangxi Medical University

Nanning, , China

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The First Affiliated Hospital of China Medical University

Shenyang, , China

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Tianjin Cancer Hospital

Tianjin, , China

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The Tumor Hospital of Xinjiang Medical University

Ürümqi, , China

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Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

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The First Affiliated Hospital of Xian Jiao Tong University

Xi'an, , China

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Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogota, D.C., , Colombia

Site Status

Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

Bogotá, , Colombia

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Oncomedica S.A.

Montería, , Colombia

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Oncólogos de Occidente

Pereira, , Colombia

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Dar El salam Cancer Centre

Cairo, , Egypt

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National Cancer Institute- Breast Cancer Treatment & Research Hospital - 5th settlement

Cairo, , Egypt

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Sohag Oncology Center

Cairo, , Egypt

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Institut Sainte Catherine

Avignon, , France

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CH de la Côte Basque - Hôpital de Bayonne

Bayonne, , France

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CHU Besançon - Hôpital Jean Minjoz

Besançon, , France

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Polyclinique Bordeaux Nord Aquitaine

Bordeaux, , France

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CHU de GRENOBLE

Grenoble, , France

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CHD Vendée

La Roche-sur-Yon, , France

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Hopital Prive Jean Mermoz

Lyon, , France

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INSTITUT CURIE_Site Paris

Paris, , France

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Centre Catalan D' Oncologie

Perpignan, , France

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Gesundheitszentrum Wetterau, Hochwaldkrankenhaus Bad Nauheim

Bad Nauheim, , Germany

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Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie

Bamberg, , Germany

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Gynäkologisches Zentrum Bonn

Bonn, , Germany

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Onkozentrum Dres. Göhler

Dresden, , Germany

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Kliniken Essen-Mitte

Essen, , Germany

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Universitätsklinikum Freiburg

Freiburg im Breisgau, , Germany

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Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, , Germany

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Ärztehaus am Bahnhofsplatz

Hildesheim, , Germany

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Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

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Dres. Andreas Köhler und Roswitha Fuchs

Langen, , Germany

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MVZ für Hämatologie und Onkologie Ravensburg GmBH

Ravensburg, , Germany

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Caritas-Krankenhaus St. Josef

Regensburg, , Germany

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Klinikum Mutterhaus der Borromaeerinnen gGmbH

Trier, , Germany

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Universitätsklinik Tübingen

Tübingen, , Germany

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Budapesti Szent Margit Korhaz

Budapest, , Hungary

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Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)

Budapest, , Hungary

Site Status

Bekes Varmegyei Központi Korhaz, Pandy Kalman Tagkorhaz

Gyula, , Hungary

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Somogy Varmegyei Kaposi Mor Oktato Korhaz

Kaposvár, , Hungary

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Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, , Hungary

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Komarom-Eszergom Varmegyei Szent Borbala Korhaz

Tatabánya, , Hungary

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Manipal Hospital

Bangalore, Karnataka, India

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Tata Memorial Hospital

Mumbai, Maharashtra, India

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Sahyadri Super Specialty Hospital Hadapsar

Pune, Maharashtra, India

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Rajiv Gandhi Cancer Inst.&Research Center

New Delhi, National Capital Territory of Delhi, India

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Fortis Hospital

New Delhi, National Capital Territory of Delhi, India

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Netaji Subhas Chandra Bose Cancer Hospital

Kolkata, West Bengal, India

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TATA Medical Centre

Kolkata, West Bengal, India

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Azienda Ospedaliera Universitaria Federico II

Napoli, Campania, Italy

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Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

Napoli, Campania, Italy

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Azienda Unità Sanitaria Locale di Reggio Emilia/IRCCS

Reggio Emilia, Emilia-Romagna, Italy

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Ospedale Infermi AUSL della Romagna

Rimini, Emilia-Romagna, Italy

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Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

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Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

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Istituto Europeo Di Oncologia

Milan, Lombardy, Italy

Site Status

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

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Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily, Italy

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Ospedale Civile

Livorno, Tuscany, Italy

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IOV - Istituto Oncologico Veneto - IRCCS

Padua, Veneto, Italy

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King Hussein Cancer Center

Amman, , Jordan

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International Cancer Institute (ICI)

Eldoret, , Kenya

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The Aga Khan University-Kenya.

Nairobi, , Kenya

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Rizk Hospital

Beirut, , Lebanon

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American University of Beirut - Medical Center

Beirut, , Lebanon

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Investigacion Oncofarmaceutica

La Paz, Baja California Sur, Mexico

Site Status

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Site Status

Iem-Fucam

D.F., Mexico CITY (federal District), Mexico

Site Status

Health Pharma Professional Research

Mexico City, Mexico CITY (federal District), Mexico

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Filios Alta Medicina

Monterrey, Nuevo León, Mexico

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Hospital Universitario

Monterrey, Nuevo León, Mexico

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Hospital Zambrano Hellion TecSalud

Monterrey, Nuevo León, Mexico

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Cuidados oncologicos

Querétaro City, Querétaro, Mexico

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Oncologico Potosino

San Luis Potosí City, San Luis Potosí, Mexico

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Centro Estatal de Cancerologia de Chihuahua

Chihuahua City, , Mexico

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Sultan Qaboos Comprehensive Cancer Care & Research Center

Muscat, , Oman

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Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Gdansk, , Poland

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Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, , Poland

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Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, , Poland

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Opolskie Centrum Onkologii

Opole, , Poland

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Ars Medical Sp. z o. o.

Pi?a, , Poland

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Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu

Późna, , Poland

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MRUKMED Lekarz Beata Madej-Mruk i Partner Spolka Partnerska Oddzial nr 1 w Rzeszowie

Rzeszów, , Poland

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Centrum Onkologii ? Instytut im. Marii Sk?odowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

Warsaw, , Poland

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IPO de Coimbra

Coimbra, , Portugal

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Hospital de S. Francisco Xavier

Lisbon, , Portugal

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Hospital Beatriz Angelo

Loures, , Portugal

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IPO do Porto

Porto, , Portugal

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King Faisal Specialist Hospital & Research Centre

Riyadh, , Saudi Arabia

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National Guard King Abdulaziz Medical City

Riyadh, , Saudi Arabia

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King Fahad Medical City

Riyadh, , Saudi Arabia

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Wits Donald Gordon Clinical Trial Centre

Parktown, Johannesburg, , South Africa

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Kyungpook National University Chilgok Hospital

Daegu, , South Korea

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National Cancer Center

Goyang-si, , South Korea

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Severance Hospital, Yonsei University Health System

Seoul, , South Korea

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Asan Medical Center

Seoul, , South Korea

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Gangnam Severance Hospital

Seoul, , South Korea

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Samsung Medical Center

Seoul, , South Korea

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Seoul St Mary's Hospital

Seoul, , South Korea

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Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Sant Andreu de la Barca, Barcelona, Spain

Site Status

Complejo Hospitalario Universitario de Santiago (CHUS)

Santiago de Compostela, LA Coruna, Spain

Site Status

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Site Status

Hospital Clínic i Provincial

Barcelona, , Spain

Site Status

Hospital Universitario Clínico San Cecilio

Granada, , Spain

Site Status

Hospital Juan Ramon Jimenez

Huelva, , Spain

Site Status

Centro Oncologico MD Anderson Internacional

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Hospital Clinico Universitario Virgen de la Victoria

Málaga, , Spain

Site Status

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Changhua Christian Hospital

Changhua, , Taiwan

Site Status

China Medical University Hospital

Taichung, , Taiwan

Site Status

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status

National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Taipei Veterans General Hospital Office of General Surgery

Taipei, , Taiwan

Site Status

Rajavithi Hospital

Bangkok, , Thailand

Site Status

Ramathibodi Hospital

Bangkok, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai, , Thailand

Site Status

Songklanagarind Hospital

Songkhla, , Thailand

Site Status

Adana Baskent University Hospital

Adana, , Turkey (Türkiye)

Site Status

Ankara Oncology Hospital

Ankara, , Turkey (Türkiye)

Site Status

Gazi Uni Medical Faculty Hospital

Ankara, , Turkey (Türkiye)

Site Status

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status

Dicle University Faculty of Medicine

Diyarbakır, , Turkey (Türkiye)

Site Status

Trakya Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, Balkan Yerleskesi

Edirne, , Turkey (Türkiye)

Site Status

Ataturk University Medical Faculty Yakutiye Research Hospital Medical Oncology Department

Erzurum, , Turkey (Türkiye)

Site Status

Prof. Dr. Cemil Tascioglu City Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Ac?badem Altunizade Hastanesi

Istanbul, , Turkey (Türkiye)

Site Status

Ege Uni Medical Faculty

Izmir, , Turkey (Türkiye)

Site Status

Katip Celebi University Ataturk Training and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status

Kocaeli University Faculty of Medicine

İzmit, , Turkey (Türkiye)

Site Status

Erciyes Uni

Kayseri, , Turkey (Türkiye)

Site Status

Antalya Memorial Hastanesi

Kepez, , Turkey (Türkiye)

Site Status

Mersin City Education and Research Hospital

Mersin, , Turkey (Türkiye)

Site Status

Ondokuz Mayis Univ. Med. Fac.

Samsun, , Turkey (Türkiye)

Site Status

Medical Park Seyhan Hospital

Seyhan, , Turkey (Türkiye)

Site Status

Namik Kemal Universitesi Tip Fakultesi, Medikal Onkoloji Bilim Dali, 100

Tekirdağ, , Turkey (Türkiye)

Site Status

Uganda Cancer Institute

Kampala, , Uganda

Site Status

Burjeel Medical City-Abu Dhabi

Abu Dhabi, , United Arab Emirates

Site Status

Tawam Hospital

Al Ain City, , United Arab Emirates

Site Status

Ysbyty Gwynedd Hospital

Bangor, , United Kingdom

Site Status

Royal United Hospital

Bath, , United Kingdom

Site Status

Blackpool Victoria Hospital

Blackpool, , United Kingdom

Site Status

University Hospital North Tees

Cleveland, , United Kingdom

Site Status

Charing Cross Hospital

London, , United Kingdom

Site Status

Maidstone Hospital

Maidstone, , United Kingdom

Site Status

Nottingham University Hospitals NHS Trust - City Hospital

Nottingham, , United Kingdom

Site Status

Royal Preston Hosp

Preston, , United Kingdom

Site Status

North Wales Cancer Treatment Centre, Glan Clwyd Hospital

Rhyl, , United Kingdom

Site Status

Singleton Hospital

Swansea, , United Kingdom

Site Status

Royal Cornwall Hospital

Truro, , United Kingdom

Site Status

Countries

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United States Argentina Belgium Brazil China Colombia Egypt France Germany Hungary India Italy Jordan Kenya Lebanon Mexico Oman Poland Portugal Saudi Arabia South Africa South Korea Spain Taiwan Thailand Turkey (Türkiye) Uganda United Arab Emirates United Kingdom

References

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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.

Reference Type DERIVED
PMID: 38789924 (View on PubMed)

Other Identifiers

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WO43571

Identifier Type: -

Identifier Source: org_study_id

2022-500014-26-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

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