Antibody-drug ConjugatesNCT06877416
Analysis of Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer
An observational study of Antibody-drug Conjugates and HER2-low Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Antibody-drug Conjugates, HER2-low Breast Cancer, Breast Neoplasms
- What is being tested?
- Non-intervention research
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to Jan 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative) who received sequential administration of two or more antibody-drug conjugates (ADCs).
Who may be able to join
- Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)
- Received sequential administration of two or more ADCs
- Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.
Who cannot join
- Concomitant with other tumor components at the time of diagnosis;
- Have a history of any other malignant tumors;
- Lack of complete data
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, 1 recruiting
- Recruiting
Sun yat-sen University Cancer
Guangzhou, Guangdong, 510060
About this study
Official title: A Multi-center, Retrospective, Study on Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer
This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms.
This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.
Read the detailed description
Breast cancer is one of the most common malignancies in women, posing a significant threat to female health. According to current molecular subtypes, breast cancer is classified into hormone receptor-positive, HER2-positive, and triple-negative breast cancer. However, with the development of novel therapeutic strategies such as antibody-drug conjugates (ADCs), increasing attention has been directed toward HER2-low breast cancer (defined as HER2 immunohistochemistry [IHC] 1+ or 2+/FISH-negative), which accounts for approximately 60%-70% of breast cancer cases. ADCs can exert potential therapeutic effects in HER2-low breast cancer through the "bystander effect" and have been widely adopted in clinical practice. Nevertheless, the optimal sequential treatment strategy for HER2-low patients remains unclear, with a lack of definitive clinical guidelines and limited understanding of resistance mechanisms.
This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients and explore potential resistance mechanisms. By conducting a retrospective analysis of clinical data from HER2-low patients treated with sequential ADCs, the investigators will evaluate the therapeutic outcomes and safety profiles of various ADC sequencing approaches. Additionally, integrating genomic profiling with routine clinical data, the investigators seek to identify prognostic biomarkers and elucidate resistance pathways. The findings are expected to guide personalized treatment strategies for HER2-low breast cancer patients, ultimately improving clinical outcomes.
- Being tested
- Non-intervention research
- Keywords
- Antibody-drug conjugates, HER2-low Breast Cancer, Retrospective Studies
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-intervention researchOther
Non-intervention research
| Study group | Role | What they receive |
|---|---|---|
| First-line Trastuzumab Deruxtecan → Second-line Sacituzumab Govitecan | Not described Receives: Other: Non-intervention research | |
| First-line Sacituzumab Govitecan → Second-line Trastuzumab Deruxtecan | Not described Receives: Other: Non-intervention research | |
| First-line RC48 → Second-line Trastuzumab Deruxtecan | Not described Receives: Other: Non-intervention research | |
| First-line Trastuzumab Deruxtecan → Second-line RC48 | Not described Receives: Other: Non-intervention research | |
| First-line SKB264 → Second-line Trastuzumab Deruxtecan | Not described Receives: Other: Non-intervention research | |
| First-line Trastuzumab Emtansine → Second-line TQB2102 | Not described Receives: Other: Non-intervention research | |
| First-line TQB2102 → Second-line Trastuzumab Deruxtecan | Not described Receives: Other: Non-intervention research | |
| First-line RC48 → Second-line TQB2102 | Not described Receives: Other: Non-intervention research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
Measured: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
Secondary outcomes (1)
Overall survival
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive.
Measured: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Jan 2020
- Primary completion1 Jan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-drug ConjugatesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yalan Yang, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877416
- Sponsor's protocol ID
- 20252696
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Retrospective, Study on Exploring Optimized Sequential Treatment Strategies of Antibody-Drug Conjugates (ADCs) in HER2-Low-Expressing Breast Cancer
- ClinicalTrials.gov ID
- NCT06877416
- Acronym / sponsor ID
- 20252696
- Keywords
- Antibody-drug conjugates, HER2-low Breast Cancer, Retrospective Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 14 Mar 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.
This study retrospectively analyzes the clinical data of HER2-low breast cancer (IHC 1+/2+ and FISH-negative) patients treated with sequential antibody-drug conjugates (ADCs). Key variables include patient demographics, tumor characteristics, ADC regimens (e.g., trastuzumab deruxtecan, sacituzumab govitecan), treatment sequencing, survival outcomes, and safety profiles. Genomic data (e.g., HER2 expression dynamics, TROP2 levels) are integrated to explore resistance mechanisms and prognostic biomarkers.mechanisms.
This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients.
Detailed description
Breast cancer is one of the most common malignancies in women, posing a significant threat to female health. According to current molecular subtypes, breast cancer is classified into hormone receptor-positive, HER2-positive, and triple-negative breast cancer. However, with the development of novel therapeutic strategies such as antibody-drug conjugates (ADCs), increasing attention has been directed toward HER2-low breast cancer (defined as HER2 immunohistochemistry [IHC] 1+ or 2+/FISH-negative), which accounts for approximately 60%-70% of breast cancer cases. ADCs can exert potential therapeutic effects in HER2-low breast cancer through the "bystander effect" and have been widely adopted in clinical practice. Nevertheless, the optimal sequential treatment strategy for HER2-low patients remains unclear, with a lack of definitive clinical guidelines and limited understanding of resistance mechanisms.
This study aims to investigate the efficacy of different ADC sequential regimens in HER2-low breast cancer patients and explore potential resistance mechanisms. By conducting a retrospective analysis of clinical data from HER2-low patients treated with sequential ADCs, the investigators will evaluate the therapeutic outcomes and safety profiles of various ADC sequencing approaches. Additionally, integrating genomic profiling with routine clinical data, the investigators seek to identify prognostic biomarkers and elucidate resistance pathways. The findings are expected to guide personalized treatment strategies for HER2-low breast cancer patients, ultimately improving clinical outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| First-line Trastuzumab Deruxtecan → Second-line Sacituzumab Govitecan | – | Other: Non-intervention research |
| First-line Sacituzumab Govitecan → Second-line Trastuzumab Deruxtecan | – | Other: Non-intervention research |
| First-line RC48 → Second-line Trastuzumab Deruxtecan | – | Other: Non-intervention research |
| First-line Trastuzumab Deruxtecan → Second-line RC48 | – | Other: Non-intervention research |
| First-line SKB264 → Second-line Trastuzumab Deruxtecan | – | Other: Non-intervention research |
| First-line Trastuzumab Emtansine → Second-line TQB2102 | – | Other: Non-intervention research |
| First-line TQB2102 → Second-line Trastuzumab Deruxtecan | – | Other: Non-intervention research |
| First-line RC48 → Second-line TQB2102 | – | Other: Non-intervention research |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative) who received sequential administration of two or more antibody-drug conjugates (ADCs).
Key inclusion criteria (3 listed)
- Diagnosed with HER2-low breast cancer, defined as immunohistochemistry (IHC) score of 1+ or IHC score of 2+ with negative in situ hybridization (FISH-negative)
- Received sequential administration of two or more ADCs
- Complete data for patient's character, laboratory and imaging test, treatment and follow-up are available.
Key exclusion criteria (3 listed)
- Concomitant with other tumor components at the time of diagnosis;
- Have a history of any other malignant tumors;
- Lack of complete data
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 |
|---|---|---|
| Non-intervention researchNon-intervention research | Other | First-line RC48 → Second-line TQB2102, First-line RC48 → Second-line Trastuzumab Deruxtecan, First-line SKB264 → Second-line Trastuzumab Deruxtecan, First-line Sacituzumab Govitecan → Second-line Trastuzumab Deruxtecan, First-line TQB2102 → Second-line Trastuzumab Deruxtecan, First-line Trastuzumab Deruxtecan → Second-line RC48, First-line Trastuzumab Deruxtecan → Second-line Sacituzumab Govitecan, First-line Trastuzumab Emtansine → Second-line TQB2102 |
Primary outcome
Progression-free survival
Time frame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse.
1 secondary outcome
Overall survival
Time frame: From date of diagnosis until the date of death from any cause, whichever came first, assessed up to 24 months.
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 20 Mar 2025.
- Individual participant dataSharing planned: No
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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 Antibody-drug Conjugates and HER2-low Breast Cancer, run by Sun Yat-sen 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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Mar 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 Yang Yalan, Bachelor (+8613826282096, yangylan7@mail2.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of diagnosis until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.). 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 20 Mar 2025.