Metastatic Breast CancerPhase 3NCT06081959
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
A Phase 3 study testing SKB264, Eribulin and Capecitabine in people with Metastatic Breast Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- SKB264, Eribulin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteChina
- Study dates
- 31 Oct 2023to 31 Dec 2027
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
- Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples;
- Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
- Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
- Expected survival ≥ 12 weeks;
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- Adequate organ and bone marrow function;
- Patients who are eligible for a chemotherapy regimen in the control group;
- Female patients of childbearing potential and male patients with partners of childbearing potential who use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose;
- Patients who voluntarily participate in the study and sign the ICF, and able to comply with the visit and related procedures stipulated in the plan.
Who cannot join
- Patients with a history of central nervous system (CNS) metastases or current CNS metastases；
- Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose;
- Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment;
- Uncontrollable systemic diseases assessed by the investigator;
- History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;
- Clinically serious lung injuries caused by lung diseases;
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- Patients with active chronic Inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding;
- Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
- Active hepatitis B or hepatitis C;
- Human immunodeficiency virus (HIV) antibody test positive or a history of acquired immunodeficiency syndrome (AIDS), known active syphilis infection;
- Known allergy or hypersensitivity to SKB264, or the excipients of SKB264;
- Prior TROP2 targeted therapy, prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy;
- Patients who received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
- Patients with concomitant infections requiring systemic antibiotic therapy within 2 week prior to the first dose of study treatment;
- Patients who have received live vaccines within 30 days prior to the first dose, or are scheduled to receive live vaccines during the study;
- Pregnant or lactating women.
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
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, 100021
BingHe Xu, PhD
About this study
Official title: A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
Read the detailed description
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.
- Conditions
- Metastatic Breast Cancer
- Being tested
- SKB264, Eribulin, Capecitabine, Gemcitabine, Vinorelbine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264Drug
IV infusion on day 1 and Day 15 of each 28 day cycle
EribulinDrug
1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
CapecitabineDrug
1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle
GemcitabineDrug
1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle
VinorelbineDrug
25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| SKB264 for injection | Experimental | Not described Receives: Drug: SKB264 |
| Treatment of Physician's Choice | Active comparator | Eribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice. Receives: Drug: Eribulin; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.
PFS, defined as the time from randomization to PD or death, whichever occurs first.
Measured: up to 24 months
Secondary outcomes (7)
Overall Survival (OS)
OS, defined as the time from randomization to death
Measured: up to 24 months
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
PFS, defined as the time from randomization to PD or death, whichever occurs first.
Measured: up to 24 months
Objective Response Rate (ORR)
The percentage of patients with CR and PR assessed by BIRC and investigators per RECIST v 1.1
Measured: up to 24 months
Disease Control Rate (DCR)
The percentage of patients who have achieved CR，PR and SD assessed by BIRC and investigators per RECIST v 1.1
Measured: up to 24 months
Duration of Response (DoR)
From the date that response criteria are first met to the first occurrence of PD as determined by BIRC and investigators per RECIST v1.1 or death from any cause, whichever occurs first
Measured: up to 24 months
Quality of life of patients evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale
To assess the impact of SKB264 on disease related symptoms and health related quality of life (HRQoL) in this patient population
Measured: Up to 2 years
AEs and SAEs
Incidence and severity of AEs and SAEs (per CTCAE 5.0), and clinically significant abnormal laboratory findings
Measured: AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start31 Oct 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.The 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 376 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081959
- Sponsor's protocol ID
- SKB264-Ⅲ-10
- Status last verified
- May 2026
- First submitted
- 7 Oct 2023
- Last updated
- 8 May 2026
- 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 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Phase 3 Study of SKB264 Versus Treatment of Physician's Choice (TPC) in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
- ClinicalTrials.gov ID
- NCT06081959
- Acronym / sponsor ID
- SKB264-Ⅲ-10
- Conditions
- Metastatic Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 376 participants (estimated)
- Lead sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Oct 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.
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
Detailed description
This is a randomized, open-label, multicenter Phase 3 clinical study to evaluate SKB264 monotherapy versus Treatment of Physician's Choice (TPC) in subjects with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer who had failed at least one line of systemic chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKB264 for injection | Experimental | Drug: SKB264 |
| Treatment of Physician's Choice | Active comparator | Drug: Eribulin, Drug: Capecitabine, Drug: Gemcitabine, Drug: VinorelbineEribulin, capecitabine, gemcitabine or vinorelbine will be administered and managed according to the investigator's clinical judgment, guided by clinical practice. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females aged ≥ 18 to ≤ 75 years at the time of signing the ICF;
- Histologically and/or cytologically confirmed HR+/HER2- breast cancer based on pathology reports on recent biopsy specimens or other pathological samples;
- Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage;
- Patients with at least one measurable lesion per RECIST 1.1 criteria; those with only skin or bone lesions cannot be included;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1;
Key exclusion criteria (16 listed)
- Patients with a history of central nervous system (CNS) metastases or current CNS metastases；
- Patients with other malignancies (except cured basal or squamous cell skin cancer or carcinoma in situ of the cervix) within 3 years prior to the first dose;
- Patients with any cardio cerebral Vascular disease or cardio cerebral vascular risk factors may affect investigational treatment;
- Uncontrollable systemic diseases assessed by the investigator;
- History of (noninfectious) interstitial lung disease (ILD)/noninfectious neumonitis requiring steroid therapy and current ILD/noninfectious pneumonitis, or ILD/noninfectious pneumonitis at screening that cannot be excluded by imaging;
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 |
|---|---|---|
| SKB264IV infusion on day 1 and Day 15 of each 28 day cycle | Drug | SKB264 for injection |
| Eribulin1.4 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle | Drug | Treatment of Physician's Choice |
| Capecitabine1000-1250 mg/m2, po, bid, from day 1 to Day 15 of each 21 day cycle | Drug | Treatment of Physician's Choice |
| Gemcitabine1000 mg/m2, IV infusion on day 1 and Day 8 of each 21day cycle | Drug | Treatment of Physician's Choice |
| Vinorelbine25 mg/m2, IV infusion on day 1 and Day 8 of each 21 day cycle | Drug | Treatment of Physician's Choice |
Primary outcome
Progression-free survival (PFS) assessed by BIRC per RECIST 1.1.
Time frame: up to 24 months
PFS, defined as the time from randomization to PD or death, whichever occurs first.
7 secondary outcomes
Overall Survival (OS)
Time frame: up to 24 months
Progression-free survival (PFS) assessed by the investigators per RECIST V 1.1
Time frame: up to 24 months
Objective Response Rate (ORR)
Time frame: up to 24 months
Disease Control Rate (DCR)
Time frame: up to 24 months
Duration of Response (DoR)
Time frame: up to 24 months
Quality of life of patients evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale
Time frame: Up to 2 years
AEs and SAEs
Time frame: AEs should be observed and recorded from signing the ICF until 30 days after the last dose. AEs occurring 30 days after the last dose are not required to be actively collected by the investigator.
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 8 May 2026.
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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?
A Phase 3 study testing SKB264, Eribulin and Capecitabine in people with Metastatic Breast Cancer, run by Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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 10 inclusion and 16 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 8 May 2026. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yina Diao (86-13402828610, diaoyina@kelun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) assessed by BIRC per RECIST 1.1. (time frame: up to 24 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 8 May 2026.