HER2-negative Breast CancerNCT06993506
Real-world Study of SKB264 Monotherapy or Combination Therapy in Recurrent or Metastatic HER2-negative Breast Cancer
An observational study of HER2-negative Breast Cancer and Recurrence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 19 sites in China.
Trial summary
This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/ HER2-BC)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-negative Breast Cancer, Recurrence, Metastasis
- What is being tested?
- SKB264 Monotherapy or Combination Therapy
- How many people
- 500 participants
- Where
- 19 sitesChina
- Study dates
- 28 May 2026to 31 Oct 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer
Who may be able to join
- Aged ≥ 18 years old at the time of signing the informed consent form, regardless of gender;
- Patient must meet one of the following pathological diagnoses and classifications:
- 2.1) For TNBC Cohort: -Histological/cytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC; -Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); 2.2) For HR+/HER2- BC Cohort: -Histological/cytological confirmed of HR+/HER2- breast cancer from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC.-Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection);
- Plan to receive SKB264 monotherapy or combination therapy;
- Prior treatment lines: -For TNBC Cohort: ≤2 lines of systemic antitumor therapy for unresectable locally advanced, recurrent, or metastatic disease; -For HR+/HER2- BC Cohort: ≤2 lines of systemic antitumor therapy (excluding endocrine therapy) for unresectable locally advanced, recurrent, or metastatic disease;
- Voluntarily participate in the study, sign the informed consent form and demonstrate good compliance.
Who cannot join
- Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;
- Patients who are currently participating in other interventional clinical studies;
- Known allergy to the investigational drug or any of its components;
- Pregnant or lactating women;
- Any situation that the researchers consider to interfere with the evaluation of the study drug or the safety of the subjects or the analysis of the study results, or any other situation that the researchers consider inappropriate to participate in this study.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites, 19 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Xue Wang, 86-010-87787242, wxyxyuki@163.com
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Ling Xu
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Weihong Zhao
- Recruiting
The first hospital of Jilin University
Changchun, Jilin, 130021
Lihua Kang
- Recruiting
The First People's Hospital of Changde City
Changde, Hunan, 415003
Tao Wu
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350000
Weiwei Huang
- Recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230601
Fanfan Li
- Recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315100
Zhengyang Xu, +86（0574）87017701
- Recruiting
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Bei Xu
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei
Zhenchuan Song, +86 0086-311-86095757
- Recruiting
Taihe Hospital
Shiyan, Hubei, 442099
Zhiguo Luo
- Recruiting
Suining Central Hospital
Suining, Sichuan, 629000
Maoshan Chen
- Recruiting
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030032
Xiaojun Zhang
- Not yet recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Yanxia Zhao
- Not yet recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
Hongmei Zheng
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Qingmo Yang
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Jiannan Liu
- Not yet recruiting
The Third People's Hospital of Zhengzhou
Zhengzhou, Henan, 450000
Lige Yao
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Fang Wang
About this study
Official title: Sacituzumab Tirumotecan Monotherapy or Combination Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer: A Real-World Study
This study is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/ HER2-BC) cohort. The aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.
- Conditions
- HER2-negative Breast Cancer, Recurrence, Metastasis
- Being tested
- SKB264 Monotherapy or Combination Therapy
- Medical subject headings
- Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKB264 Monotherapy or Combination TherapyDrug
The interventions in this study comprised SKB264 monotherapy or combination therapy involving SKB264. The specific combination regimens were determined based on real-world clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| TNBC Cohort | * Histological/cytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC;
* Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection) Receives: Drug: SKB264 Monotherapy or Combination Therapy | |
| HR+/HER2- BC Cohort | * Histological/cytological confirmed of HR+/HER2- breast cancer from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC.
* Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); Receives: Drug: SKB264 Monotherapy or Combination Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer
Measured: Time from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 weeks.
Secondary outcomes (5)
Real world progression free survival (rwPFS) of SKB264 monotherapy or combination therapy
Measured: Time from initiation of SKB264 monotherapy or combination therapy to the first documented evidence of progression or death, whichever came first, assessed up to 24 weeks.
Duration of treatment (DOT) of SKB264 monotherapy or combination therapy
Measured: Time from initiation of SKB264 monotherapy or combination therapy to its discontinuation, assessed up to 24 weeks.
Real world objective response rate (rwORR) of SKB264 monotherapy or combination therapy
Measured: The proportion of patients who had a complete or partial response documented by imaging reports or by assessment of treating physician during the study treatment, which is approximately up to 24 weeks from the initiation of the study treatment.
Real world overall survival (rwOS) of SKB264 monotherapy or combination therapy
Measured: Time from initiation of SKB264 monotherapy or combination therapy to death from any cause, assessed up to 48 weeks.
Number of patients with adverse events of SKB264 monotherapy or combination therapy in the real-world setting, graded and recorded according to NCI CTCAE v5.0.
Measured: Adverse events were assessed during study treatment and at follow-up visits, which is approximately up to 30 weeks from the initiation of the study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start28 May 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-negative Breast CancerStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PENG YUAN, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06993506
- Sponsor's protocol ID
- NCC5312
- Status last verified
- Aug 2026
- First submitted
- 12 May 2025
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sacituzumab Tirumotecan Monotherapy or Combination Therapy in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer: A Real-World Study
- ClinicalTrials.gov ID
- NCT06993506
- Acronym / sponsor ID
- NCC5312
- Conditions
- HER2-negative Breast Cancer, Recurrence, Metastasis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 28 May 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 29 May 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 is a multi-center observational real-world study, with a total of 500 patients planned to be enrolled. This study is divided into two cohorts: the triple-negative breast cancer (TNBC) cohort and the hormone receptor-positive/human epidermal growth factor receptor 2-negative breast cancer (HR+/ HER2-BC) cohort. The aim of this study is to assess the efficacy and safety of Sacituzumab Tirumotecan (SKB264) monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer in the real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TNBC Cohort | – | Drug: SKB264 Monotherapy or Combination Therapy* Histological/cytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC; * Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection) |
| HR+/HER2- BC Cohort | – | Drug: SKB264 Monotherapy or Combination Therapy* Histological/cytological confirmed of HR+/HER2- breast cancer from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC. * Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Unresectable Locally Advanced, Recurrent or Metastatic HER2-Negative Breast Cancer
Key inclusion criteria (6 listed)
- Aged ≥ 18 years old at the time of signing the informed consent form, regardless of gender;
- Patient must meet one of the following pathological diagnoses and classifications:
- 2.1) For TNBC Cohort: -Histological/cytological confirmed of triple-negative breast cancer (TNBC) from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: immunohistochemistry (IHC) of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by fluorescence in situ hybridization (FISH); Estrogen and progesterone receptor negative means that less than 1% of the cells express hormone receptors as indicated by IHC; -Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection); 2.2) For HR+/HER2- BC Cohort: -Histological/cytological confirmed of HR+/HER2- breast cancer from the most recent pre-SKB264 biopsy/pathological report, with: HER2 negative: IHC of 0 or 1+; if is 2+ by IHC, negative HER2 expression must be confirmed by FISH; HR positive: Hormone receptor-positive (HR, ER, or PR status) was defined as ≥1% expression by IHC.-Locally advanced, recurrent, or metastatic disease (locally advanced disease should be confirmed by investigators as ineligible for curative resection);
- Plan to receive SKB264 monotherapy or combination therapy;
- Prior treatment lines: -For TNBC Cohort: ≤2 lines of systemic antitumor therapy for unresectable locally advanced, recurrent, or metastatic disease; -For HR+/HER2- BC Cohort: ≤2 lines of systemic antitumor therapy (excluding endocrine therapy) for unresectable locally advanced, recurrent, or metastatic disease;
Key exclusion criteria (5 listed)
- Patients with other malignancies, except cured basal or squamous cell skin cancer or in situ cancer of cervix; and patients with other malignancies must have a tumor-free period of at least 5 years;
- Patients who are currently participating in other interventional clinical studies;
- Known allergy to the investigational drug or any of its components;
- Pregnant or lactating women;
- Any situation that the researchers consider to interfere with the evaluation of the study drug or the safety of the subjects or the analysis of the study results, or any other situation that the researchers consider inappropriate to participate in this 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 |
|---|---|---|
| SKB264 Monotherapy or Combination TherapyThe interventions in this study comprised SKB264 monotherapy or combination therapy involving SKB264. The specific combination regimens were determined based on real-world clinical practice. | Drug | HR+/HER2- BC Cohort, TNBC Cohort |
Primary outcome
Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 weeks.
5 secondary outcomes
Real world progression free survival (rwPFS) of SKB264 monotherapy or combination therapy
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to the first documented evidence of progression or death, whichever came first, assessed up to 24 weeks.
Duration of treatment (DOT) of SKB264 monotherapy or combination therapy
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to its discontinuation, assessed up to 24 weeks.
Real world objective response rate (rwORR) of SKB264 monotherapy or combination therapy
Time frame: The proportion of patients who had a complete or partial response documented by imaging reports or by assessment of treating physician during the study treatment, which is approximately up to 24 weeks from the initiation of the study treatment.
Real world overall survival (rwOS) of SKB264 monotherapy or combination therapy
Time frame: Time from initiation of SKB264 monotherapy or combination therapy to death from any cause, assessed up to 48 weeks.
Number of patients with adverse events of SKB264 monotherapy or combination therapy in the real-world setting, graded and recorded according to NCI CTCAE v5.0.
Time frame: Adverse events were assessed during study treatment and at follow-up visits, which is approximately up to 30 weeks from the initiation of the study treatment.
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 18 Aug 2026.
- 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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-negative Breast Cancer and Recurrence, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 19 sites 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 6 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 Xue Wang, M.D. (86-010-87787242, wxyxyuki@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to next treatment (TTNT) of SKB264 monotherapy or combination therapy in patients with unresectable locally advanced, recurrent or metastatic HER2-negative breast cancer (time frame: Time from initiation of SKB264 monotherapy or combination therapy to start of next treatment, assessed up to 24 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 18 Aug 2026.