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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

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
Active, not 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
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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
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Mexico
State/province [186] 0 0
México
Country [187] 0 0
Mexico
State/province [187] 0 0
Puebla
Country [188] 0 0
Mexico
State/province [188] 0 0
San Pedro Garza García
Country [189] 0 0
Mexico
State/province [189] 0 0
Yucatán
Country [190] 0 0
Poland
State/province [190] 0 0
Gdansk
Country [191] 0 0
Poland
State/province [191] 0 0
Krakow
Country [192] 0 0
Poland
State/province [192] 0 0
Lodz
Country [193] 0 0
Poland
State/province [193] 0 0
Lublin
Country [194] 0 0
Poland
State/province [194] 0 0
Warszawa
Country [195] 0 0
Portugal
State/province [195] 0 0
Braga
Country [196] 0 0
Portugal
State/province [196] 0 0
Guimarães
Country [197] 0 0
Portugal
State/province [197] 0 0
Lisbon
Country [198] 0 0
Portugal
State/province [198] 0 0
Matosinhos
Country [199] 0 0
Singapore
State/province [199] 0 0
Singapore
Country [200] 0 0
South Africa
State/province [200] 0 0
Gauteng
Country [201] 0 0
South Africa
State/province [201] 0 0
Johannesburg
Country [202] 0 0
South Africa
State/province [202] 0 0
Kraaifontein
Country [203] 0 0
Spain
State/province [203] 0 0
Barcelona
Country [204] 0 0
Spain
State/province [204] 0 0
Bilbo
Country [205] 0 0
Spain
State/province [205] 0 0
Córdoba
Country [206] 0 0
Spain
State/province [206] 0 0
Elche
Country [207] 0 0
Spain
State/province [207] 0 0
Jaen
Country [208] 0 0
Spain
State/province [208] 0 0
Madrid
Country [209] 0 0
Spain
State/province [209] 0 0
Salamanca
Country [210] 0 0
Spain
State/province [210] 0 0
Santiago de Compostela
Country [211] 0 0
Spain
State/province [211] 0 0
Sevilla
Country [212] 0 0
Spain
State/province [212] 0 0
Seville
Country [213] 0 0
Spain
State/province [213] 0 0
Valencia
Country [214] 0 0
Taiwan
State/province [214] 0 0
Kaohsiung City
Country [215] 0 0
Taiwan
State/province [215] 0 0
Kaohsiung
Country [216] 0 0
Taiwan
State/province [216] 0 0
New Taipei City
Country [217] 0 0
Taiwan
State/province [217] 0 0
Tainan City
Country [218] 0 0
Taiwan
State/province [218] 0 0
Tainan
Country [219] 0 0
Taiwan
State/province [219] 0 0
Taipei City
Country [220] 0 0
Taiwan
State/province [220] 0 0
Taipei
Country [221] 0 0
Taiwan
State/province [221] 0 0
Taoyuan City
Country [222] 0 0
United Kingdom
State/province [222] 0 0
London
Country [223] 0 0
United Kingdom
State/province [223] 0 0
Manchester
Country [224] 0 0
United Kingdom
State/province [224] 0 0
Nottingham

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05840211