Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05840211




Registration number
NCT05840211
Ethics application status
Date submitted
21/04/2023
Date registered
3/05/2023
Date last updated
21/06/2024

Titles & IDs
Public 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
Scientific 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
Secondary ID [1] 0 0
2022-502593-17-00
Secondary ID [2] 0 0
GS-US-598-6168
Universal Trial Number (UTN)
Trial acronym
ASCENT-07
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Locally Advanced or Unresectable Metastatic Breast Cancer 0 0
Stage IV Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Sacituzumab Govitecan-hziy
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab-paclitaxel
Treatment: Drugs - Capecitabine

Experimental: Sacituzumab Govitecan-hziy (SG) - Participants will receive SG at a dose of 10 mg/kg infusion on Days 1 and 8 of a 21-day cycle.

Active comparator: Treatment of Physician's Choice (TPC) - 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.


Treatment: Drugs: Sacituzumab Govitecan-hziy
Administered intravenously

Treatment: Drugs: Paclitaxel
Administered intravenously

Treatment: Drugs: Nab-paclitaxel
Administered intravenously

Treatment: Drugs: Capecitabine
Administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Up to approximately 29 months
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Until death, up to approximately 60 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) as Assessed by BICR per RECIST Version 1.1
Timepoint [2] 0 0
Until progression, up to approximately 60 months
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Baseline, Week 16
Secondary outcome [4] 0 0
Time to Deterioration in Version 3.0 EORTC-QLQ-C30 Scores
Timepoint [4] 0 0
Up to approximately 60 months
Secondary outcome [5] 0 0
Progression Free Survival (PFS) as Assessed by Investigator per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timepoint [5] 0 0
Until progression or death, up to approximately 60 months
Secondary outcome [6] 0 0
Objective Response Rate (ORR) as Assessed by Investigator per RECIST Version 1.1
Timepoint [6] 0 0
Up to approximately 60 months
Secondary outcome [7] 0 0
Duration of Response (DOR) as Assessed by BICR and Investigator per RECIST Version 1.1
Timepoint [7] 0 0
Until progression or death, up to approximately 60 months
Secondary outcome [8] 0 0
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Timepoint [8] 0 0
First dose date up to 30 days post last dose, up to approximately 60 months
Secondary outcome [9] 0 0
Percentage of Participants Experiencing Clinically Significant Laboratory and/or Vital Sign Abnormalities
Timepoint [9] 0 0
First dose date up to 30 days post last dose, up to approximately 60 months

Eligibility
Key inclusion criteria
Key

* Able to understand and give written informed consent.
* Must have adequate tumor tissue sample preferably from locally recurrent or metastatic site.
* Documented evidence of HR+ metastatic breast cancer (mBC) confirmed with the most recently available tumor biopsy preferably 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 at least 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 (if ineligible or if unable to access a 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 PARP inhibitors (for those with germline BRCA1 or BRCA2 mutations), 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 and use of any investigational device or drug (drugs not marketed for any indication) either within 5 half-lives or 28 days prior to randomization, whichever is longer.

* Use of investigational drugs in the category of Selective Estrogen Receptor Degraders are acceptable if last dose was longer than 14 days prior to randomization.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
654
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
MENSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Queensland
Recruitment hospital [2] 0 0
St Vincent's Hospital Sydney - Darlinghurst
Recruitment hospital [3] 0 0
Liverpool Hospital - Liverpool
Recruitment hospital [4] 0 0
GenesisCare North Shore (Oncology) - St Leonards
Recruitment hospital [5] 0 0
Icon Cancer Centre Wesley - Auchenflower
Recruitment hospital [6] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [7] 0 0
Icon Cancer Centre Hobart - Hobart
Recruitment hospital [8] 0 0
Austin Health - Melbourne
Recruitment hospital [9] 0 0
Sunshine Hospital (Western Health) - St Albans
Recruitment hospital [10] 0 0
Breast Cancer Research Centre - WA - Nedlands
Recruitment postcode(s) [1] 0 0
4029 - Queensland
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2170 - Liverpool
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
5042 - Bedford Park
Recruitment postcode(s) [7] 0 0
7000 - Hobart
Recruitment postcode(s) [8] 0 0
3084 - Melbourne
Recruitment postcode(s) [9] 0 0
3021 - St Albans
Recruitment postcode(s) [10] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Kansas
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New Jersey
Country [11] 0 0
United States of America
State/province [11] 0 0
New York
Country [12] 0 0
United States of America
State/province [12] 0 0
Ohio
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
South Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Tennessee
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Argentina
State/province [18] 0 0
Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
C.a.b.a.
Country [20] 0 0
Argentina
State/province [20] 0 0
Caba
Country [21] 0 0
Argentina
State/province [21] 0 0
Cordoba
Country [22] 0 0
Argentina
State/province [22] 0 0
Rosario
Country [23] 0 0
Argentina
State/province [23] 0 0
San Juan
Country [24] 0 0
Austria
State/province [24] 0 0
Innsbruck
Country [25] 0 0
Austria
State/province [25] 0 0
Salzburg
Country [26] 0 0
Austria
State/province [26] 0 0
Wels
Country [27] 0 0
Austria
State/province [27] 0 0
Wien
Country [28] 0 0
Belgium
State/province [28] 0 0
Antwerpen
Country [29] 0 0
Belgium
State/province [29] 0 0
Brasschaat
Country [30] 0 0
Belgium
State/province [30] 0 0
Brussels
Country [31] 0 0
Belgium
State/province [31] 0 0
Leuven
Country [32] 0 0
Belgium
State/province [32] 0 0
Namur
Country [33] 0 0
Brazil
State/province [33] 0 0
Fortaleza
Country [34] 0 0
Brazil
State/province [34] 0 0
Goiânia
Country [35] 0 0
Brazil
State/province [35] 0 0
Ijui
Country [36] 0 0
Brazil
State/province [36] 0 0
Itajai
Country [37] 0 0
Brazil
State/province [37] 0 0
Minas Gerais
Country [38] 0 0
Brazil
State/province [38] 0 0
Natal
Country [39] 0 0
Brazil
State/province [39] 0 0
Paraana
Country [40] 0 0
Brazil
State/province [40] 0 0
Paraná
Country [41] 0 0
Brazil
State/province [41] 0 0
Pernambuco
Country [42] 0 0
Brazil
State/province [42] 0 0
Porto Alegre
Country [43] 0 0
Brazil
State/province [43] 0 0
Rio de Janeiro
Country [44] 0 0
Brazil
State/province [44] 0 0
Rio Grande Do Sul
Country [45] 0 0
Brazil
State/province [45] 0 0
Santo Andre
Country [46] 0 0
Brazil
State/province [46] 0 0
São Paulo
Country [47] 0 0
Canada
State/province [47] 0 0
Kelowna
Country [48] 0 0
Canada
State/province [48] 0 0
Ottawa
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
Canada
State/province [50] 0 0
Toronto
Country [51] 0 0
Canada
State/province [51] 0 0
Victoria
Country [52] 0 0
Chile
State/province [52] 0 0
Recoleta
Country [53] 0 0
Chile
State/province [53] 0 0
Region Metropolitana
Country [54] 0 0
Chile
State/province [54] 0 0
Santiago Region
Country [55] 0 0
Chile
State/province [55] 0 0
Temuco
Country [56] 0 0
Chile
State/province [56] 0 0
Vina del Mar
Country [57] 0 0
China
State/province [57] 0 0
Anhui
Country [58] 0 0
China
State/province [58] 0 0
Beijing
Country [59] 0 0
China
State/province [59] 0 0
Changchun
Country [60] 0 0
China
State/province [60] 0 0
Changsha
Country [61] 0 0
China
State/province [61] 0 0
Chengdu
Country [62] 0 0
China
State/province [62] 0 0
Chongqing
Country [63] 0 0
China
State/province [63] 0 0
Fujian
Country [64] 0 0
China
State/province [64] 0 0
Fuzhou
Country [65] 0 0
China
State/province [65] 0 0
Guangdong
Country [66] 0 0
China
State/province [66] 0 0
Guangzhou
Country [67] 0 0
China
State/province [67] 0 0
Hangzhou
Country [68] 0 0
China
State/province [68] 0 0
Heilongjiang
Country [69] 0 0
China
State/province [69] 0 0
Jiangsu
Country [70] 0 0
China
State/province [70] 0 0
Jiangxi
Country [71] 0 0
China
State/province [71] 0 0
Jilin Sheng
Country [72] 0 0
China
State/province [72] 0 0
Jinan
Country [73] 0 0
China
State/province [73] 0 0
Nanchang
Country [74] 0 0
China
State/province [74] 0 0
Ningxia Hui
Country [75] 0 0
China
State/province [75] 0 0
Qingdao
Country [76] 0 0
China
State/province [76] 0 0
Shanghai
Country [77] 0 0
China
State/province [77] 0 0
Tianjin
Country [78] 0 0
China
State/province [78] 0 0
Wuhan
Country [79] 0 0
China
State/province [79] 0 0
Xi'an
Country [80] 0 0
China
State/province [80] 0 0
Zhejiang
Country [81] 0 0
China
State/province [81] 0 0
Zhengzhou
Country [82] 0 0
Czechia
State/province [82] 0 0
Brno
Country [83] 0 0
Czechia
State/province [83] 0 0
Olomouc
Country [84] 0 0
Czechia
State/province [84] 0 0
Pardubice
Country [85] 0 0
Czechia
State/province [85] 0 0
Prague 4
Country [86] 0 0
Czechia
State/province [86] 0 0
Prague
Country [87] 0 0
Czechia
State/province [87] 0 0
Zlin
Country [88] 0 0
France
State/province [88] 0 0
Besancon
Country [89] 0 0
France
State/province [89] 0 0
Bordeaux
Country [90] 0 0
France
State/province [90] 0 0
Dijon
Country [91] 0 0
France
State/province [91] 0 0
Lille
Country [92] 0 0
France
State/province [92] 0 0
Loire Atlantique
Country [93] 0 0
France
State/province [93] 0 0
Lyon
Country [94] 0 0
France
State/province [94] 0 0
Marseille
Country [95] 0 0
France
State/province [95] 0 0
Montpellier Cedex 5
Country [96] 0 0
France
State/province [96] 0 0
Paris
Country [97] 0 0
France
State/province [97] 0 0
Pierre-benite
Country [98] 0 0
France
State/province [98] 0 0
Plerin
Country [99] 0 0
France
State/province [99] 0 0
Rennes Cedex
Country [100] 0 0
France
State/province [100] 0 0
Rouen
Country [101] 0 0
France
State/province [101] 0 0
Toulouse Cedex 9
Country [102] 0 0
France
State/province [102] 0 0
Villejuif
Country [103] 0 0
Germany
State/province [103] 0 0
Bayern
Country [104] 0 0
Germany
State/province [104] 0 0
Berlin
Country [105] 0 0
Germany
State/province [105] 0 0
Bottrop
Country [106] 0 0
Germany
State/province [106] 0 0
Erlangen
Country [107] 0 0
Germany
State/province [107] 0 0
Gera
Country [108] 0 0
Germany
State/province [108] 0 0
Hamburg
Country [109] 0 0
Germany
State/province [109] 0 0
Hannover
Country [110] 0 0
Germany
State/province [110] 0 0
Heidelberg
Country [111] 0 0
Germany
State/province [111] 0 0
Mannheim
Country [112] 0 0
Germany
State/province [112] 0 0
Munster
Country [113] 0 0
Germany
State/province [113] 0 0
München
Country [114] 0 0
Germany
State/province [114] 0 0
Tübingen
Country [115] 0 0
Greece
State/province [115] 0 0
Athens
Country [116] 0 0
Greece
State/province [116] 0 0
Heraklion
Country [117] 0 0
Greece
State/province [117] 0 0
Larissa
Country [118] 0 0
Greece
State/province [118] 0 0
Patras
Country [119] 0 0
Greece
State/province [119] 0 0
Thessaloniki
Country [120] 0 0
Hong Kong
State/province [120] 0 0
Hong Kong
Country [121] 0 0
Hong Kong
State/province [121] 0 0
New Territories
Country [122] 0 0
Hong Kong
State/province [122] 0 0
Pok Fu Lam
Country [123] 0 0
Hungary
State/province [123] 0 0
Budapest
Country [124] 0 0
Hungary
State/province [124] 0 0
Debrecen
Country [125] 0 0
Hungary
State/province [125] 0 0
Kecskemét
Country [126] 0 0
Hungary
State/province [126] 0 0
Nyiregyhaza
Country [127] 0 0
Hungary
State/province [127] 0 0
Szeged
Country [128] 0 0
Israel
State/province [128] 0 0
Haifa
Country [129] 0 0
Israel
State/province [129] 0 0
Jerusalem
Country [130] 0 0
Israel
State/province [130] 0 0
Petah Tikva
Country [131] 0 0
Israel
State/province [131] 0 0
Ramat Gan
Country [132] 0 0
Israel
State/province [132] 0 0
Tel Aviv
Country [133] 0 0
Italy
State/province [133] 0 0
Ancona AN
Country [134] 0 0
Italy
State/province [134] 0 0
Aviano
Country [135] 0 0
Italy
State/province [135] 0 0
Bergamo
Country [136] 0 0
Italy
State/province [136] 0 0
Bologna
Country [137] 0 0
Italy
State/province [137] 0 0
Catania
Country [138] 0 0
Italy
State/province [138] 0 0
Catanzaro
Country [139] 0 0
Italy
State/province [139] 0 0
Genova GE
Country [140] 0 0
Italy
State/province [140] 0 0
Milano
Country [141] 0 0
Italy
State/province [141] 0 0
Milan
Country [142] 0 0
Italy
State/province [142] 0 0
Monza
Country [143] 0 0
Italy
State/province [143] 0 0
Napoli
Country [144] 0 0
Italy
State/province [144] 0 0
Padova
Country [145] 0 0
Italy
State/province [145] 0 0
Rionero in Vulture
Country [146] 0 0
Italy
State/province [146] 0 0
Roma
Country [147] 0 0
Italy
State/province [147] 0 0
Rozzano
Country [148] 0 0
Japan
State/province [148] 0 0
Aichi
Country [149] 0 0
Japan
State/province [149] 0 0
Aoba-ku
Country [150] 0 0
Japan
State/province [150] 0 0
Bunkyo-ku
Country [151] 0 0
Japan
State/province [151] 0 0
Chiba
Country [152] 0 0
Japan
State/province [152] 0 0
Chuo-ku
Country [153] 0 0
Japan
State/province [153] 0 0
Ehime
Country [154] 0 0
Japan
State/province [154] 0 0
Fukushima
Country [155] 0 0
Japan
State/province [155] 0 0
Kagoshima-shi
Country [156] 0 0
Japan
State/province [156] 0 0
Kanagawa
Country [157] 0 0
Japan
State/province [157] 0 0
Kashiwa
Country [158] 0 0
Japan
State/province [158] 0 0
Kitaadachi-gun
Country [159] 0 0
Japan
State/province [159] 0 0
Koto-Ku
Country [160] 0 0
Japan
State/province [160] 0 0
Kumamoto- shi
Country [161] 0 0
Japan
State/province [161] 0 0
Kyoto-shi
Country [162] 0 0
Japan
State/province [162] 0 0
Minami-ku
Country [163] 0 0
Japan
State/province [163] 0 0
Nagoya
Country [164] 0 0
Japan
State/province [164] 0 0
Naka-ku
Country [165] 0 0
Japan
State/province [165] 0 0
Nishinomiya-shi
Country [166] 0 0
Japan
State/province [166] 0 0
Okayama
Country [167] 0 0
Japan
State/province [167] 0 0
Ota
Country [168] 0 0
Japan
State/province [168] 0 0
Sapporo
Country [169] 0 0
Japan
State/province [169] 0 0
Shinjuku-ku
Country [170] 0 0
Japan
State/province [170] 0 0
Tokyo
Country [171] 0 0
Japan
State/province [171] 0 0
Yokohama
Country [172] 0 0
Korea, Republic of
State/province [172] 0 0
Gangnam-Gu
Country [173] 0 0
Korea, Republic of
State/province [173] 0 0
Goyang-si Gyeonggi-do
Country [174] 0 0
Korea, Republic of
State/province [174] 0 0
Gyeongsangbuk-do
Country [175] 0 0
Korea, Republic of
State/province [175] 0 0
Incheon
Country [176] 0 0
Korea, Republic of
State/province [176] 0 0
Seongnam
Country [177] 0 0
Korea, Republic of
State/province [177] 0 0
Seoul
Country [178] 0 0
Malaysia
State/province [178] 0 0
Kuala Lumpur
Country [179] 0 0
Malaysia
State/province [179] 0 0
Kuching
Country [180] 0 0
Malaysia
State/province [180] 0 0
Putrajaya
Country [181] 0 0
Mexico
State/province [181] 0 0
Cancún
Country [182] 0 0
Mexico
State/province [182] 0 0
Mexico City
Country [183] 0 0
Mexico
State/province [183] 0 0
México
Country [184] 0 0
Mexico
State/province [184] 0 0
Puebla
Country [185] 0 0
Mexico
State/province [185] 0 0
San Pedro Garza García
Country [186] 0 0
Mexico
State/province [186] 0 0
Yucatán
Country [187] 0 0
Poland
State/province [187] 0 0
Gdansk
Country [188] 0 0
Poland
State/province [188] 0 0
Krakow
Country [189] 0 0
Poland
State/province [189] 0 0
Lodz
Country [190] 0 0
Poland
State/province [190] 0 0
Lublin
Country [191] 0 0
Poland
State/province [191] 0 0
Warszawa
Country [192] 0 0
Portugal
State/province [192] 0 0
Braga
Country [193] 0 0
Portugal
State/province [193] 0 0
Guimarães
Country [194] 0 0
Portugal
State/province [194] 0 0
Lisbon
Country [195] 0 0
Portugal
State/province [195] 0 0
Matosinhos
Country [196] 0 0
Singapore
State/province [196] 0 0
Singapore
Country [197] 0 0
South Africa
State/province [197] 0 0
Gauteng
Country [198] 0 0
South Africa
State/province [198] 0 0
Johannesburg
Country [199] 0 0
South Africa
State/province [199] 0 0
Kraaifontein
Country [200] 0 0
Spain
State/province [200] 0 0
Barcelona
Country [201] 0 0
Spain
State/province [201] 0 0
Bilbo
Country [202] 0 0
Spain
State/province [202] 0 0
Córdoba
Country [203] 0 0
Spain
State/province [203] 0 0
Elche
Country [204] 0 0
Spain
State/province [204] 0 0
Jaen
Country [205] 0 0
Spain
State/province [205] 0 0
Madrid
Country [206] 0 0
Spain
State/province [206] 0 0
Salamanca
Country [207] 0 0
Spain
State/province [207] 0 0
Santiago de Compostela
Country [208] 0 0
Spain
State/province [208] 0 0
Sevilla
Country [209] 0 0
Spain
State/province [209] 0 0
Seville
Country [210] 0 0
Spain
State/province [210] 0 0
Valencia
Country [211] 0 0
Taiwan
State/province [211] 0 0
Kaohsiung City
Country [212] 0 0
Taiwan
State/province [212] 0 0
Kaohsiung
Country [213] 0 0
Taiwan
State/province [213] 0 0
New Taipei City
Country [214] 0 0
Taiwan
State/province [214] 0 0
Tainan City
Country [215] 0 0
Taiwan
State/province [215] 0 0
Tainan
Country [216] 0 0
Taiwan
State/province [216] 0 0
Taipei City
Country [217] 0 0
Taiwan
State/province [217] 0 0
Taipei
Country [218] 0 0
Taiwan
State/province [218] 0 0
Taoyuan City
Country [219] 0 0
United Kingdom
State/province [219] 0 0
London
Country [220] 0 0
United Kingdom
State/province [220] 0 0
Manchester
Country [221] 0 0
United Kingdom
State/province [221] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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 currently 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).
Trial website
https://clinicaltrials.gov/study/NCT05840211
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gilead Clinical Study Information Center
Address 0 0
Country 0 0
Phone 0 0
1-833-445-3230 (GILEAD-0)
Fax 0 0
Email 0 0
GileadClinicalTrials@gilead.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05840211