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Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy (ASCENT-07)

Primary Purpose

Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Sacituzumab Govitecan-hziy
Paclitaxel
Nab-paclitaxel
Capecitabine
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced or Unresectable Metastatic Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria: Able to understand and give written informed consent. Must have adequate tumor tissue sample from locally recurrent or metastatic site. Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy from a locally recurrent or metastatic site. Documented evidence of HER2- status. Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria. Candidate for the first chemotherapy in the locally advanced or metastatic setting. Eligible for capecitabine, nab-paclitaxel, or paclitaxel. Individuals must have one of the following: Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting. Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting. Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting. Individuals may have received prior targeted therapies, including but not limited to phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations) or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies. Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease. Demonstrates adequate organ function. Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: Progressive disease within 6 months of completing (neo)adjuvant chemotherapy. Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment. Current enrollment in another clinical study or use of any investigational device or drug either within 5 half-lives or 28 days prior to randomization, whichever is longer. Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I. Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC. Have an active second malignancy. Have an active serious infection requiring antibiotics. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • Ironwood Physicians P.C. dba Ironwood Cancer and Research CentersRecruiting
  • Los Angeles Hematology Oncology Medical GroupRecruiting
  • University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer CenterRecruiting
  • Investigational Drug Services, AdventHealth OrlandoRecruiting
  • Florida Cancer SpecialistsRecruiting
  • Florida Cancer SpecialistRecruiting
  • Florida Cancer SpecialistRecruiting
  • Piedmont Cancer InstituteRecruiting
  • Georgia Cancer Specialist - AnnexRecruiting
  • Northwest Georgia Oncology CentersRecruiting
  • The University of Kansas HospitalRecruiting
  • Hematology Oncology ClinicRecruiting
  • David C. Pratt Cancer CenterRecruiting
  • Astera Cancer CareRecruiting
  • Rutgers Cancer Institute of New JerseyRecruiting
  • Cleveland ClinicRecruiting
  • Magee-Womens of UPMCRecruiting
  • MultiCare Regional Cancer Center - AuburnRecruiting
  • Sunshine Hospital (Western Health)Recruiting
  • Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur OnkologieRecruiting
  • AZ KlinaRecruiting
  • CHU UCL Namur-Site STE. ElisabethRecruiting
  • CHU de Québec-Université Laval, Hôpital du Saint-SacrementRecruiting
  • Hong Kong Integrated Oncology CentreRecruiting
  • Aichi Cancer Center HospitalRecruiting
  • Chiba Cancer CenterRecruiting
  • Osaka Prefectural Hospital Organization Osaka International Cancer InstituteRecruiting
  • Saitama Cancer CenterRecruiting
  • Cancer Institute Hospital of JFCRRecruiting
  • Okayama University HospitalRecruiting
  • Gunma Prefectural Cancer CenterRecruiting
  • National Hospital Organization Hokkaido Cancer CenterRecruiting
  • Center Hospital of the National Center for Global Health and MedicineRecruiting
  • Kanagawa Cancer CenterRecruiting
  • Gachon University Gil Medical CenterRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Seoul National University HospitalRecruiting
  • Severance Hospital, Yonsei University Health SystemRecruiting
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.oRecruiting
  • Instytut MSF Sp. z o.o.Recruiting
  • Tan Tock Seng HospitalRecruiting
  • Hospital Clinic de BarcelonaRecruiting
  • Hospital Universitario Reina SofiaRecruiting
  • Hospital Universitario Ramón y CajalRecruiting
  • Hospital Universitario 12 de OctubreRecruiting
  • Hospital Universitario Virgen del RocioRecruiting
  • Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Tri-Service General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sacituzumab Govitecan-hziy (SG)

Treatment of Physician's Choice (TPC)

Arm Description

Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.

Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.

Secondary Outcome Measures

Overall Survival (OS)
OS is defined as the time from randomization until the date of death from any cause.
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores
Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities

Full Information

First Posted
April 21, 2023
Last Updated
October 17, 2023
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05840211
Brief Title
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
Acronym
ASCENT-07
Official Title
A Randomized, Open-label, Phase 3 Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) (HER2 IHC0 or HER2-low [IHC 1+, IHC 2+/ISH-]) Inoperable, Locally Advanced, or Metastatic Breast Cancer and Have Received Endocrine Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 8, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
December 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to current available standard treatments, such as paclitaxel, nab-paclitaxel or capecitabine. The primary objective is to compare the effect of SG relative to the treatment of physician's choice (TPC) on progression-free survival (PFS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
654 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sacituzumab Govitecan-hziy (SG)
Arm Type
Experimental
Arm Description
Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.
Arm Title
Treatment of Physician's Choice (TPC)
Arm Type
Active Comparator
Arm Description
Participants will receive TPC determined prior to randomization to 1 of the 3 allowed regimens: paclitaxel 80 mg/m^2 over 1 hour (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. nab-Paclitaxel 100 mg/m^2 over 30 minutes (± 10 minutes) on Days 1, 8, and 15 of a 28-day cycle. capecitabine at 1000-1250 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period of a 21-day cycle.
Intervention Type
Drug
Intervention Name(s)
Sacituzumab Govitecan-hziy
Other Intervention Name(s)
Trodelvy™, GS-0132, IMMU-132
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Other Intervention Name(s)
Taxol®
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Nab-paclitaxel
Other Intervention Name(s)
Abraxane®
Intervention Description
Administered intravenously
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeloda®
Intervention Description
Administered orally
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Description
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) or death from any cause, whichever comes first.
Time Frame
Up to approximately 29 months
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
OS is defined as the time from randomization until the date of death from any cause.
Time Frame
Until death, up to approximately 60 months
Title
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Description
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Time Frame
Until progression, up to approximately 60 months
Title
Change from Baseline in the Physical Functioning Domain Using European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Version 3.0 (EORTC QLQ-C30) at Week 16
Description
The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The Physical Functioning domain includes 5 questions in which participants will be asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 4 (excellent), with a higher score representing a high QoL.
Time Frame
Baseline, Week 16
Title
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores
Description
Time to deterioration from baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) scores. Scale scores range from 0-100. For functioning and global health status/QoL scales, higher scores indicate better functioning or global health status/QoL. For symptom scales, higher scores indicate greater symptom burden.
Time Frame
Up to approximately 60 months
Title
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Description
PFS is defined as time from date of randomization until the date of first objective progressive disease (PD) by investigator assessment according to RECIST v1.1 or death from any cause, whichever comes first.
Time Frame
Until progression or death, up to approximately 60 months
Title
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
Description
ORR is defined as the proportion of participants who achieve a complete response (CR) or partial response (PR) that is confirmed at least 4 weeks after initial documentation of response.
Time Frame
Up to approximately 60 months
Title
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
Description
DOR is defined as the time from the first documentation of CR or PR to the earlier of the first documentation of objective PD or death from any cause (whichever comes first).
Time Frame
Until progression or death, up to approximately 60 months
Title
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame
First dose date up to 30 days post last dose, up to approximately 60 months
Title
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
Time Frame
First dose date up to 30 days post last dose, up to approximately 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Able to understand and give written informed consent. Must have adequate tumor tissue sample from locally recurrent or metastatic site. Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy from a locally recurrent or metastatic site. Documented evidence of HER2- status. Documented PD by computed tomography (CT) or magnetic resonance imaging during or after the most recent therapy per RECIST v1.1 criteria. Candidate for the first chemotherapy in the locally advanced or metastatic setting. Eligible for capecitabine, nab-paclitaxel, or paclitaxel. Individuals must have one of the following: Disease progression on at least 2 or more previous lines of endocrine therapy (ET) with or without a targeted therapy in the metastatic setting. Disease recurrence while on the first 24 months of starting adjuvant ET will be considered a line of therapy; these individuals will only require 1 line of ET in the metastatic setting. Disease progression within 6 months of starting first-line ET with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor in the metastatic setting. Disease recurrence while on the first 24 months of starting adjuvant ET with CDK 4/6 inhibitor and if the individual is no longer a candidate for additional ET in the metastatic setting. Individuals may have received prior targeted therapies, including but not limited to phosphatidylinositol 3-kinase (PI3K) inhibitors (for those with PIK3CA mutations) or mammalian target of rapamycin (mTOR) inhibitors. However, individuals can no longer be candidates for additional endocrine treatment with or without targeted therapies. Individuals with HIV must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease. Demonstrates adequate organ function. Male individuals and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Key Exclusion Criteria: Progressive disease within 6 months of completing (neo)adjuvant chemotherapy. Locally advanced metastatic breast cancer (mBC) (Stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment. Current enrollment in another clinical study or use of any investigational device or drug either within 5 half-lives or 28 days prior to randomization, whichever is longer. Received any prior treatment (including antibody-drug conjugate (ADC)) containing a chemotherapeutic agent targeting topoisomerase I. Received any prior treatment with a trophoblast cell-surface antigen 2 (Trop-2)-directed ADC. Have an active second malignancy. Have an active serious infection requiring antibiotics. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV). Individuals positive for human immunodeficiency virus type 1/2 (HIV-1 or -2) with a history of Kaposi sarcoma and/or Multicentric Castleman Disease. Have a positive serum pregnancy test or are breastfeeding for individuals who are assigned female at birth. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilead Clinical Study Information Center
Phone
1-833-445-3230 (GILEAD-0)
Email
GileadClinicalTrials@gilead.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Ironwood Physicians P.C. dba Ironwood Cancer and Research Centers
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Recruiting
Facility Name
Los Angeles Hematology Oncology Medical Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Name
Investigational Drug Services, AdventHealth Orlando
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialists
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialist
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Cancer Specialist
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Name
Georgia Cancer Specialist - Annex
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Individual Site Status
Recruiting
Facility Name
Northwest Georgia Oncology Centers
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Individual Site Status
Recruiting
Facility Name
The University of Kansas Hospital
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Hematology Oncology Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Individual Site Status
Recruiting
Facility Name
David C. Pratt Cancer Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Astera Cancer Care
City
East Brunswick
State/Province
New Jersey
ZIP/Postal Code
08816
Country
United States
Individual Site Status
Recruiting
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
Magee-Womens of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Name
MultiCare Regional Cancer Center - Auburn
City
Auburn
State/Province
Washington
ZIP/Postal Code
98001
Country
United States
Individual Site Status
Recruiting
Facility Name
Sunshine Hospital (Western Health)
City
St Albans
State/Province
Victoria
ZIP/Postal Code
3021
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universitat Wien, Univ. Klinik fur Innere Medizin I Klinische Abteilung fur Onkologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
AZ Klina
City
Brasschaat
ZIP/Postal Code
2930
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur-Site STE. Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU de Québec-Université Laval, Hôpital du Saint-Sacrement
City
Quebec
ZIP/Postal Code
G1S 4L8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Hong Kong Integrated Oncology Centre
City
Hong Kong
ZIP/Postal Code
0
Country
Hong Kong
Individual Site Status
Recruiting
Facility Name
Aichi Cancer Center Hospital
City
Aichi
ZIP/Postal Code
464-8681
Country
Japan
Individual Site Status
Recruiting
Facility Name
Chiba Cancer Center
City
Chiba
ZIP/Postal Code
260-8717
Country
Japan
Individual Site Status
Recruiting
Facility Name
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
City
Chuo-ku
ZIP/Postal Code
541-8567
Country
Japan
Individual Site Status
Recruiting
Facility Name
Saitama Cancer Center
City
Kitaadachi-gun
ZIP/Postal Code
362-0806
Country
Japan
Individual Site Status
Recruiting
Facility Name
Cancer Institute Hospital of JFCR
City
Koto-Ku
ZIP/Postal Code
135-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
Okayama University Hospital
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gunma Prefectural Cancer Center
City
Ota
ZIP/Postal Code
373-8550
Country
Japan
Individual Site Status
Recruiting
Facility Name
National Hospital Organization Hokkaido Cancer Center
City
Sapporo
ZIP/Postal Code
003-0804
Country
Japan
Individual Site Status
Recruiting
Facility Name
Center Hospital of the National Center for Global Health and Medicine
City
Shinjuku-ku
ZIP/Postal Code
162-8655
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kanagawa Cancer Center
City
Yokohama
ZIP/Postal Code
241-8515
Country
Japan
Individual Site Status
Recruiting
Facility Name
Gachon University Gil Medical Center
City
Incheon
ZIP/Postal Code
21565
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z.o.o
City
Krakow
ZIP/Postal Code
31-826
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut MSF Sp. z o.o.
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Individual Site Status
Recruiting
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocio
City
Seville
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Tri-Service General Hospital
City
Taipei
ZIP/Postal Code
11490
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.gileadclinicaltrials.com/study?nctid=NCT05840211
Description
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Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy

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