Metastatic Breast CancerNCT04857619
Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 44 sites in 6 countries.
Trial summary
This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- None (Observational study)
- How many people
- 763 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 14 May 2021to 31 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will include patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting.
Who may be able to join
- Adult female or male patients ≥18 years old or 'adults' according to the age of majority as defined by the local regulations
- Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC
- Patients' medical records showing a diagnosis of HER2-positive unresectable or mBC (can be either de novo advanced disease, progression or recurrence of previous early-stage HER2-positive BC) since the available date of T-DM1 (Kadcyla) through reimbursement or patient access programme as a valid local treatment option or 01 January 2017, whichever is earlier and with the availability of at least 12 months of follow-up data (from the date of diagnosis of unresectable or mBC) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis
- Patients completing at least 1 LOT for HER2-positive unresectable or mBC
Who cannot join
- Patients with HER2-negative unresectable or mBC at index diagnosis
- Patients with a change in HER2 status from positive to negative at the progression from early-stage to advanced-stage disease (ie, shown on a repeat biopsy at diagnosis of advanced-stage disease) will be excluded (patients who change from HER2-positive to negative on repeat biopsy during treatment for advanced-stage disease may be included)
- Patients with concomitant cancer at the time of diagnosis of HER2-positive unresectable or mBC except for the non-metastatic non-melanoma skin cancers, or in situ, or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HER2-positive breast cancer diagnosis
- Patients who at the time of data collection for this study are participating or have participated in an interventional study that remains blinded
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
Brazil16 sites
Research Site
Cachoeiro de Itapemirim, Espírito Santo, 29308 014
Research Site
Caxias do Sul, Rio Grande do Sul, 85020 450
Research Site
Curitiba, Paraná, 80040 170
Research Site
Fortaleza, Ceará, 60336 232
Research Site
Fortaleza, 60416 130
Research Site
Goiânia, 74605 070
Research Site
Itajaí, Santa Catarina, 88301 220
Research Site
Manaus, Amazonas, 69056 037
Research Site
Porto Alegre, Rio Grande do Sul, 90035 001
Research Site
Porto Alegre, Rio Grande do Sul, 90610 000
Research Site
Rio de Janeiro, 22250 905
Research Site
Salvador, Estado de Bahia, 40170 110
Research Site
Salvador, Estado de Bahia, 41950 640
Research Site
Santo André, São Paulo, 09060 650
Research Site
São Paulo, 01321 001
Research Site
São Paulo, 04502 001
South Korea8 sites
Research Site
Goyang, 10408
Research Site
Incheon, Incheon Gwang Yeogsi, 21565
Research Site
Seoul, Seoul Teugbyeolsi, 03080
Research Site
Seoul, Seoul Teugbyeolsi, 03722
Research Site
Seoul, Seoul Teugbyeolsi, 5505
Research Site
Seoul, Seoul Teugbyeolsi, 6351
Research Site
Seoul, Seoul Teugbyeolsi, 8308
Research Site
Seoul, 2841
Taiwan8 sites
Research Site
Kaohsiung City, 824
Research Site
Taichung, 404
Research Site
Taichung, 40705
Research Site
Tainan, 70403
Research Site
Tainan County, Tainan, 71004
Research Site
Taipei, 100
Research Site
Taipei, 11217
Research Site
Taipei, 11490
Australia5 sites
Research Site
Macquarie, New South Wales, 2109
Research Site
Newcastle, New South Wales, 2305
Research Site
Parramatta, New South Wales, 2145
Research Site
Perth, Western Australia
Research Site
St Leonards, New South Wales, 2065
Singapore4 sites
Research Site
Singapore, Central Singapore, 217562
Research Site
Singapore, South East, 308433
Research Site
Singapore, 119228
Research Site
Singapore, 609606
Hong Kong3 sites
Research Site
Hong Kong, 150001
Research Site
Hong Kong
Research Site
Kowloon
About this study
Official title: A Multicountry, Multicentre, Non-interventional, Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of treatment (LOTs), and survival outcomes in the real-world setting.
Read the detailed description
The study will involve patients diagnosed with HER2-positive unresectable or mBC since the earlier date between the date of trastuzumab emtansine ([T-DM1] Kadcyla) becoming available through reimbursement or patient access programme as a valid local treatment option or 01 January 2017 and who received at least 1 LOT. The data will be collected from the date of diagnosis of unresectable or mBC (index date) to the end of follow-up (ie, until death, the last medical record entry, or date of data extraction, whichever is earlier). The study will not have any study-specific patient visits or a longitudinal follow-up. All available data will be extracted from patients' medical records or obtained from patients themselves after obtaining an informed consent unless a waiver is granted by the local Institutional Review Board (IRB)/Institutional Ethics Committee (IEC)/Ethics Committee (EC). The informed consent may be obtained at the time of patients routine clinical care visit to the oncology centre. The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics will be extracted from patients medical records up to the date informed consent was obtained.
This study will be conducted in non-US and non-European countries including Australia, Brazil, Hong Kong, Korea, Singapore and Taiwan. The total number of patients in the study will be approximately a minimum of 570 and a maximum of 830 patients. The study will be implemented at approximately 50 to 100 oncology centres spanning across 6 countries in the AstraZeneca (AZ) International Region (ie, non-US, non-European countries).
- Conditions
- Metastatic Breast Cancer
- Being tested
- None (Observational study)
- Keywords
- Human epidermal growth factor receptor 2 - positive, Retrospective
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
Also called Observational study
The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics and healthcare resource utilisation will be extracted from patients' medical records (both alive and deceased).
| Study group | Role | What they receive |
|---|---|---|
| Retrospective | Patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting will be included. Approximately a total of 570-830 patients will be enrolled in the study. Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT
Assessment of treatment patterns in patients diagnosed with HER2-positive unresectable or mBC. Line of treatment (LOT) is defined as one regimen, possibly a combination of several drugs, given from either the index diagnosis or disease progression until the treatment fails to control the disease, is not tolerated by the patient, the disease relapses/progresses, or death occurs.
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Duration of therapy (DoT) for each regimen in each LOT
Assessment of length of time from initiation of therapy to permanent discontinuation. The DoT will be calculated as the time from the date of initiation of LOT to the stop of the treatment regimen for every LOT as per dates available in the medical record.
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Percentage of patients receiving local and regional treatment for metastasis
Assessment of local and regional treatment for metastasis (radiotherapy and/or surgery), and bone protection therapy
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Secondary outcomes (7)
Demographic and clinico-pathological characteristics of patients with HER2-positive unresectable or mBC
Descriptive statistics will be used to describe socio-demographic and clinico-pathological characteristics for the overall study.
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world disease progression
Real-world disease progression of unresectable or mBC is defined as that documented in either the radiology report, pathology reports or clinician note as cancer progression.
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world progression free survival (rwPFS)
Real-world PFS is defined as the time from date of initiation of LOT to documented disease progression or death, whichever occurs first. Occurrence and date of disease progression in rwPFS will be determined from documentation within the patient record, such as pathology reports, imaging report notes, and statements about disease progression in the oncologist progress notes. Patients without an event (progression/death) will be censored at last date of assessment.
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Overall survival
Length of time from the date of diagnosis of unresectable or mBC or date of initiation of LOT to death due to any cause. If patient is not dead until the last record available or date of data extraction, then time-to-event will be calculated for that date. Patients who are known to be alive at the date of data collection will be censored at the date of data collection. Patients who are lost to follow up will be censored on the date they were last known to be alive (eg. date of last recorded hospital visit).
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world objective response rate
The percentage of patients who have achieved real-world partial response (rwPR) and real-world complete response (rwCR) to therapy for each LOT.
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world disease control rate
The percentage of patients with rwCR, rwPR and real-world stable disease (rwSD) during treatment for each LOT
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Percentage of Proportion of patients with AESIs that led to treatment discontinuations, hospitalisatons and deaths.
Assessment of safety and tolerability of different treatment regimens in patients with HER2-positive unresectable or mBC.
Measured: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start14 May 2021
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 763 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857619
- Sponsor's protocol ID
- D9673R00005
- Status last verified
- Jul 2024
- First submitted
- 21 Apr 2021
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicountry, Multicentre, Non-interventional, Retrospective Study to Describe the Real-world Treatment Patterns and Associated Outcomes in Patients With HER2-positive Unresectable or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04857619
- Acronym / sponsor ID
- D9673R00005
- Conditions
- Metastatic Breast Cancer
- Keywords
- Human epidermal growth factor receptor 2 - positive, Retrospective
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 763 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 14 May 2021 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multicountry, multicenter, retrospective, non-interventional study involving patients diagnosed with HER2-positive unresectable or metastatic breast cancer mBC will be conducted to understand the demographic and clinico-pathological profile of the patients, diagnostic practices for human epidermal growth factor receptor 2 (HER2) status, current treatment landscape and sequencing of therapies, associated burden of toxicities with all lines of treatment (LOTs), and survival outcomes in the real-world setting.
Detailed description
The study will involve patients diagnosed with HER2-positive unresectable or mBC since the earlier date between the date of trastuzumab emtansine ([T-DM1] Kadcyla) becoming available through reimbursement or patient access programme as a valid local treatment option or 01 January 2017 and who received at least 1 LOT. The data will be collected from the date of diagnosis of unresectable or mBC (index date) to the end of follow-up (ie, until death, the last medical record entry, or date of data extraction, whichever is earlier). The study will not have any study-specific patient visits or a longitudinal follow-up. All available data will be extracted from patients' medical records or obtained from patients themselves after obtaining an informed consent unless a waiver is granted by the local Institutional Review Board (IRB)/Institutional Ethics Committee (IEC)/Ethics Committee (EC). The informed consent may be obtained at the time of patients routine clinical care visit to the oncology centre. The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics will be extracted from patients medical records up to the date informed consent was obtained.
This study will be conducted in non-US and non-European countries including Australia, Brazil, Hong Kong, Korea, Singapore and Taiwan. The total number of patients in the study will be approximately a minimum of 570 and a maximum of 830 patients. The study will be implemented at approximately 50 to 100 oncology centres spanning across 6 countries in the AstraZeneca (AZ) International Region (ie, non-US, non-European countries).
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retrospective | – | Other: None (Observational study)Patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting will be included. Approximately a total of 570-830 patients will be enrolled in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will include patients who are diagnosed with HER2-positive unresectable or mBC and have received at least 1 LOT in the advanced setting.
Key inclusion criteria (4 listed)
- Adult female or male patients ≥18 years old or 'adults' according to the age of majority as defined by the local regulations
- Patient or next of kin/legal representative willing and able to provide written informed consent according to the local regulations unless a waiver is granted by the local IRB/IEC/EC
- Patients' medical records showing a diagnosis of HER2-positive unresectable or mBC (can be either de novo advanced disease, progression or recurrence of previous early-stage HER2-positive BC) since the available date of T-DM1 (Kadcyla) through reimbursement or patient access programme as a valid local treatment option or 01 January 2017, whichever is earlier and with the availability of at least 12 months of follow-up data (from the date of diagnosis of unresectable or mBC) in the medical records at the participating site, unless patient died within the first 12 months of diagnosis
- Patients completing at least 1 LOT for HER2-positive unresectable or mBC
Key exclusion criteria (4 listed)
- Patients with HER2-negative unresectable or mBC at index diagnosis
- Patients with a change in HER2 status from positive to negative at the progression from early-stage to advanced-stage disease (ie, shown on a repeat biopsy at diagnosis of advanced-stage disease) will be excluded (patients who change from HER2-positive to negative on repeat biopsy during treatment for advanced-stage disease may be included)
- Patients with concomitant cancer at the time of diagnosis of HER2-positive unresectable or mBC except for the non-metastatic non-melanoma skin cancers, or in situ, or benign neoplasms; a cancer is considered concomitant if it occurs within 5 years of HER2-positive breast cancer diagnosis
- Patients who at the time of data collection for this study are participating or have participated in an interventional study that remains blinded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)Also: Observational studyThe data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics and healthcare resource utilisation will be extracted from patients' medical records (both alive and deceased). | Other | Retrospective |
Primary outcome
Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Assessment of treatment patterns in patients diagnosed with HER2-positive unresectable or mBC. Line of treatment (LOT) is defined as one regimen, possibly a combination of several drugs, given from either the index diagnosis or disease progression until the treatment fails to control the disease, is not tolerated by the patient, the disease relapses/progresses, or death occurs.
Duration of therapy (DoT) for each regimen in each LOT
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Assessment of length of time from initiation of therapy to permanent discontinuation. The DoT will be calculated as the time from the date of initiation of LOT to the stop of the treatment regimen for every LOT as per dates available in the medical record.
Percentage of patients receiving local and regional treatment for metastasis
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Assessment of local and regional treatment for metastasis (radiotherapy and/or surgery), and bone protection therapy
7 secondary outcomes
Demographic and clinico-pathological characteristics of patients with HER2-positive unresectable or mBC
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world disease progression
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world progression free survival (rwPFS)
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Overall survival
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world objective response rate
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Real-world disease control rate
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Percentage of Proportion of patients with AESIs that led to treatment discontinuations, hospitalisatons and deaths.
Time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Redacted CSR synopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com /ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by AstraZeneca at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Brazil, South Korea, Taiwan, Australia, Singapore and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients receiving each treatment regimen with or without hormonal therapy in each LOT (time frame: Retrospective: from date of first diagnosis of unresectable or mBC (01 January 2017) to the end of follow-up (i.e., until death, the last medical record entry, or date of data extraction, whichever is the earliest) [Approximately 12 Months]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.