TNBC - Triple-Negative Breast CancerNCT06798506
Real-world Patient-reported Outcome of Sacituzumab Govitecan in Chinese Metastatic Triple-negative Breast Cancer
An observational study of TNBC - Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
The aim of this trial is to explore the real-world patient-reported health-related quality of life (HRQOL), functioning, symptoms and symptom tolerability of sacituzumab govitecan or chemotherapy of the physician's choice for Chinese mTNBC patients. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- TNBC - Triple-Negative Breast Cancer
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 15 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients have been diagnosed with metastatic triple-negative breast cancer (mTNBC). ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections.
Who may be able to join
- Patients aged over 18 years old.
- Patients have been diagnosed with metastatic triple-negative breast cancer (mTNBC). ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. ER-negative and PgR-negative status was defined as≤1% staining in the nuclei by IHC. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio <2.0 if IHC 2+ or IHC not performed.
- The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- Patients who have received at least 1 prior regimen in the metastatic setting.
- Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
- Available medical history.
- All patients can provide an informed consent before enrolment and data collection.
Who cannot join
- If participating in any controlled clinical trial, the subject cannot take part in this study.
- HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
- Pregnancy and lactation.
- Severe hepatic impairment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Biyun Wang, +86 18017312387, pro_wangbiyun@163.com
About this study
Official title: A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Triple-negative Breast Cancer
The aim of this trial is to explore the real-world patient-reported health-related quality of life (HRQOL), functioning, symptoms and symptom tolerability of sacituzumab govitecan or chemotherapy of the physician's choice for Chinese mTNBC patients. Evaluation of HRQOL and functioning using the EORTC QLQ-C30 and QLQ-BR45 questionnaires, including change from baseline and time to deterioration in each scale or item. Treatment-related symptoms and tolerability were assessed using the Patient-Reported Outcomes of the PRO-CTCAE and PGI-TT questionnaires.
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- Sacituzumab Govitecan, chemotherapy, metastatic breast cancer, TNBC
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sacituzumab Govitecan cohort | Not described | |
| Chemotherapy of the physician's choice cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported HRQOL
Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires
Measured: 6 weeks
Secondary outcomes (8)
Patient-reported functioning
Patient-reported functioning evaluated by QLQ-BR45 questionnaires.
Measured: 6 weeks
Patient-reported symptoms
Treatment-related symptoms were assessed using the Patient-Reported Outcomes of the PRO-CTCAE.
Measured: 6 weeks
Patient-reported tolerability
Treatment-related tolerability were assessed using the Patient-Reported Outcomes of the PGI-TT questionnaires.
Measured: 6 weeks
PFS
Progression free survival
Measured: 6 weeks
ORR
Overall Response Rate
Measured: 6 weeks
CBR
Clinical benefit Rates
Measured: 6 weeks
OS
Overall Survival
Measured: 6 weeks
Safety
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TNBC - Triple-Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Biyun Wang, MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798506
- Sponsor's protocol ID
- YOUNGBC-32
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world, Multicenter, Prospective Study to Evaluate the Patient-reported Outcome in Chinese Patients Who Received Sacituzumab Govitecan or Chemotherapy of the Physician's Choice for Metastatic Triple-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06798506
- Acronym / sponsor ID
- YOUNGBC-32
- Conditions
- TNBC - Triple-Negative Breast Cancer
- Keywords
- Sacituzumab Govitecan, chemotherapy, metastatic breast cancer, TNBC
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 29 Jan 2025 (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.
The aim of this trial is to explore the real-world patient-reported health-related quality of life (HRQOL), functioning, symptoms and symptom tolerability of sacituzumab govitecan or chemotherapy of the physician's choice for Chinese mTNBC patients. Evaluation of HRQOL and functioning using the EORTC QLQ-C30 and QLQ-BR45 questionnaires, including change from baseline and time to deterioration in each scale or item. Treatment-related symptoms and tolerability were assessed using the Patient-Reported Outcomes of the PRO-CTCAE and PGI-TT questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sacituzumab Govitecan cohort | – | – |
| Chemotherapy of the physician's choice cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients have been diagnosed with metastatic triple-negative breast cancer (mTNBC). ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections.
Key inclusion criteria (7 listed)
- Patients aged over 18 years old.
- Patients have been diagnosed with metastatic triple-negative breast cancer (mTNBC). ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patients' primary or metastatic tumor sections. ER-negative and PgR-negative status was defined as≤1% staining in the nuclei by IHC. HER2-negative status was defined by IHC staining 0 to 1+ or fluorescence in situ hybridization ratio <2.0 if IHC 2+ or IHC not performed.
- The metastatic disease was confirmed by clinical, imaging, histological, or cytological measures, including unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
- Patients who have received at least 1 prior regimen in the metastatic setting.
- Plan to receive or has received sacituzumab govitecan monotherapy or chemotherapy of the physician's choice.
Key exclusion criteria (4 listed)
- If participating in any controlled clinical trial, the subject cannot take part in this study.
- HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
- Pregnancy and lactation.
- Severe hepatic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-reported HRQOL
Time frame: 6 weeks
Patient-reported health-related quality of life (HRQOL) evaluated by EORTC QLQ-C30 questionnaires
8 secondary outcomes
Patient-reported functioning
Time frame: 6 weeks
Patient-reported symptoms
Time frame: 6 weeks
Patient-reported tolerability
Time frame: 6 weeks
PFS
Time frame: 6 weeks
ORR
Time frame: 6 weeks
CBR
Time frame: 6 weeks
OS
Time frame: 6 weeks
Safety
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TNBC - Triple-Negative Breast Cancer, run by Fudan University at 1 site in China.
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 7 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: opening soon, as of the sponsor's last update on 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Biyun Wang, Professor (+86 13701748410, pro_wangbiyun@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported HRQOL (time frame: 6 weeks). 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 29 Jan 2025.