Breast CancerPhase 1/2NCT05824325
Different Targeted Antibody-drug Conjugates For HER2 Ultra-low or No Expression Advanced Breast Cancer（GALAXY）
A Phase 1/2 study testing SHR-A1811 and TROP2 ADC in people with Breast Cancer, run by Fudan University at 1 site in China.
Trial summary
This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- SHR-A1811 and TROP2 ADC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 14 Mar 2023to 10 Oct 2026
- Phase
- Phase 1/2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ECOG Performance Status of 0 or 1
- Pathologically documented breast cancer that:
- is advanced or metastatic
- is histologically confirmed to be HER2 IHC 0 (ISH- or untested)
- was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- Disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic breast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must have progressed after at least 1 line of endocrine therapy with or without CDK4/6 inhibitor.
- Has protocol-defined adequate organ and bone marrow function. Ability to understand and willingness to sign a written informed consent document.
Who cannot join
- Has previously been treated with any anti-HER2 therapy. Known prior severe hypersensitivity to investigational product or any component in its formulation and other monoclonal antibodies.
- Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.
- History of other malignancy than breast cancer within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
- Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.
- Has uncontrolled intercurrent illness or significant cardiovascular disease. History of clinically significant lung diseases. History of immunodeficiency, including HIV positive. Known active hepatitis B virus or hepatitis C virus infection. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Different Targeted Antibody-drug Conjugates for HER2 Ultra-low or no Expression Advanced Breast Cancer: a Phase Ⅰb/Ⅱ Study（GALAXY）
This is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer
- Conditions
- Breast Cancer
- Being tested
- SHR-A1811, TROP2 ADC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR-A1811Drug
HER2 ADC
TROP2 ADCDrug
TROP2 ADC
| Study group | Role | What they receive |
|---|---|---|
| Experimental: HER2 ADC | Experimental | Patients diagnosed with HER2 ultra-low or no expression are recruited Receives: Drug: SHR-A1811 |
| Experimental: TROP2 ADC | Experimental | Patients diagnosed with HER2 ultra-low or no expression are recruited. Receives: Drug: TROP2 ADC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events (AEs)- Phase 1
Occurrence of AEs in Phase 1 graded according to CTCAE v5.0
Measured: Up to follow-up period, approximately 24 months
Objective Response Rate (ORR)- Phase 2
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
Measured: Until progression, assessed up to approximately 24 months
Secondary outcomes (7)
Progression Free Survival (PFS
Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.
Measured: Until progression, assessed up to approximately 24 months
Overall Survival (OS)
time to death due to any cause
Measured: Until death, assessed up to approximately 24 months
Duration of Response (DoR)
Time from the date of first documented response until the date of documented progression or death in the absence of disease progression.
Measured: Until progression, assessed up to approximately 24 months
Disease Control Rate (DCR)
The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.
Measured: Baseline through end of study, assessed up to 24 months
Clinical Benefit Rate (CBR)
The percentage of subjects with CR, PR and SD≥24 weeks，as determined by the Investigator at local site per RECIST 1.1.
Measured: Until progression or death, assessed up to approximately 24 months
Exploratory analyses
HER2-PET was done at baseline to further explore the clinical utility of HER2-PET for HER2 detection
Measured: Baseline until disease progression or loss of clinical benefit, assessed up to 24 months
Safety
Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
Measured: Up to follow-up period, approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start14 Mar 2023
- Primary completion10 Apr 2025 (estimated)
- Study completion10 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05824325
- Sponsor's protocol ID
- GALAXY
- Status last verified
- Jun 2023
- First submitted
- 5 Mar 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Targeted Antibody-drug Conjugates for HER2 Ultra-low or no Expression Advanced Breast Cancer: a Phase Ⅰb/Ⅱ Study（GALAXY）
- ClinicalTrials.gov ID
- NCT05824325
- Acronym / sponsor ID
- GALAXY
- Conditions
- Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 14 Mar 2023 (actual)
- Primary completion
- 10 Apr 2025 (estimated)
- Study completion
- 10 Oct 2026 (estimated)
- First posted
- 21 Apr 2023 (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 is a phaseⅠb/Ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for HER2 ultra-low or no expression advanced breast cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: HER2 ADC | Experimental | Drug: SHR-A1811Patients diagnosed with HER2 ultra-low or no expression are recruited |
| Experimental: TROP2 ADC | Experimental | Drug: TROP2 ADCPatients diagnosed with HER2 ultra-low or no expression are recruited. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ECOG Performance Status of 0 or 1
- is advanced or metastatic
- is histologically confirmed to be HER2 IHC 0 (ISH- or untested)
- was never previously HER2-positive (IHC 3+ or ISH+) At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1.
- Disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic breast cancer. Subjects with HER2-negative and hormone-receptor positive tumors must have progressed after at least 1 line of endocrine therapy with or without CDK4/6 inhibitor.
Key exclusion criteria (5 listed)
- Has previously been treated with any anti-HER2 therapy. Known prior severe hypersensitivity to investigational product or any component in its formulation and other monoclonal antibodies.
- Any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration.
- History of other malignancy than breast cancer within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ).
- Meningeal metastasis or active brain parenchymal metastasis. Any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of > 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration.
- Has uncontrolled intercurrent illness or significant cardiovascular disease. History of clinically significant lung diseases. History of immunodeficiency, including HIV positive. Known active hepatitis B virus or hepatitis C virus infection. Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study.
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 |
|---|---|---|
| SHR-A1811HER2 ADC | Drug | Experimental: HER2 ADC |
| TROP2 ADCTROP2 ADC | Drug | Experimental: TROP2 ADC |
Primary outcome
Occurrence of adverse events (AEs)- Phase 1
Time frame: Up to follow-up period, approximately 24 months
Occurrence of AEs in Phase 1 graded according to CTCAE v5.0
Objective Response Rate (ORR)- Phase 2
Time frame: Until progression, assessed up to approximately 24 months
The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.
7 secondary outcomes
Progression Free Survival (PFS
Time frame: Until progression, assessed up to approximately 24 months
Overall Survival (OS)
Time frame: Until death, assessed up to approximately 24 months
Duration of Response (DoR)
Time frame: Until progression, assessed up to approximately 24 months
Disease Control Rate (DCR)
Time frame: Baseline through end of study, assessed up to 24 months
Clinical Benefit Rate (CBR)
Time frame: Until progression or death, assessed up to approximately 24 months
Exploratory analyses
Time frame: Baseline until disease progression or loss of clinical benefit, assessed up to 24 months
Safety
Time frame: Up to follow-up period, approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SHR-A1811 and TROP2 ADC in people with 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 5 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Occurrence of adverse events (AEs)- Phase 1 (time frame: Up to follow-up period, approximately 24 months). The study lists 2 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 27 Jun 2023.