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ER+HER2- Breast CancerPhase 2NeoSaciANCT07109284

SKB264 Combined With KL-A167 Neoadjuvant Therapy for Early-stage, High-risk ER+/HER2- Breast Cancer

A Phase 2 study testing Sacituzumab tirumotecan and Tagitanlimab in people with ER+HER2- Breast Cancer, run by West China Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This study aimed to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant therapy in early-stage high-risk ER+HER2- breast cancer patients. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
ER+HER2- Breast Cancer
What is being tested?
Sacituzumab tirumotecan and Tagitanlimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
Sep 2025to Dec 2030
Phase
Phase 2
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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Females aged 18-70 years;
  • Pathologically confirmed invasive ductal breast cancer and untreated previously；
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1;
  • Life expectancy ≥3 months;
  • Have at least 1 measurable disease defined by RECIST v1.1;
  • T1c-T2 (tumor size ≥2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2;
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  • Has confirmed ER+/HER2-：ER≥1%、HER2 IHC 0、1+ or 2+/ISH-）;
  • Tumor Grade 3 of ductal histology, Or Tumor Grade 2 of ductal histology having an ER expression level percentage between 1-10%
  • Tissue or blood available for biomarker assessment;
  • Adequate organ function;
  • Patients with negative serum pregnancy test and those with fertility potential must agree to use effective contraception during the treatment period and for at least 3 months after the last dose of study drugs;
  • Patients must voluntarily participate in this study, sign an informed consent form, exhibit good compliance, and be willing to cooperate with follow-up procedures；

Who cannot join

  • Inflammatory BC；
  • Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
  • Has bilateral invasive breast cancer.
  • Has metastatic (stage IV) breast cancer.
  • Has left ventricular ejection fraction (LVEF) of <50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
  • Has received prior treatment for breast cancer.
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  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX 40, CD137).
  • Has received prior treatment for targeting TROP2 and/or topoisomerase I;
  • Patients who have had other malignancies within the past five years will be excluded from the study, with exceptions for those who have been successfully treated for cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma of the skin;
  • Has hypersensitivity to any of the components or excipients used in the study treatments.
  • History of allogeneic organ transplantation;
  • Patients with a history of non-infectious interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, those currently diagnosed with ILD or non-infectious pneumonia, or those with suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging at the time of screening, will be excluded. Additionally, patients suffering from clinically severe pulmonary damage due to pulmonary comorbidities will also be excluded. This includes, but is not limited to, any underlying pulmonary disease (such as pulmonary embolism within the past three months, severe asthma, advanced chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory conditions potentially affecting the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), as well as those who have undergone a pneumonectomy.
  • Patients with active autoimmune diseases requiring systemic treatment within the past two years will be excluded from the study. Systemic treatment does not include hormone replacement therapy, such as insulin therapy for Type 1 Diabetes, thyroid hormone replacement for hypothyroidism, or physiological doses of glucocorticoids for adrenal or pituitary insufficiency.
  • Patients with active infection requiring systemic therapy.
  • According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study, including but not limited to high blood pressure beyond the control of drugs, serious diabetes, active infection, etc.
  • Patients for whom participation in the study was deemed to be inappropriate by the investigator for any other reason were also excluded.

About this study

Official title: A Single Arm, Multi-center Phase II Study of Neoadjuvant Therapy With Sacituzumab Tirumotecan (Sac-TMT) and KL-A167 for Early-stage, High-risk ER+/HER2- Breast Cancer (NeoSaciA)

This study aimed to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant therapy in early-stage high-risk ER+HER2- breast cancer patients.

Read the detailed description

This is a single-arm, multi-center, phase II clinical trial to evaluate the efficacy and safety of SKB264 combined with KL-A167 as neoadjuvant treatment for early-stage high-risk ER+HER2- breast cancer. Eligible patients receive intravenous injections of 5mg/kg SKB264 and 900mg KL-167 every 2 weeks, with a total duration of 18 weeks for neoadjuvant therapy.

During neoadjuvant therapy, tumor assessments will be conducted every 6 weeks, followed by surgery after neoadjuvant therapy is completed. Following surgery, participants have the option to receive additional adjuvant therapy at the discretion of the treating physician. Participants will be followed at least every 6 months initially as per standard clinical practice.

The primary endpoint is to determine the pCR rate of SKB264 combined with KL-A167. Secondary endpoints include ORR, EFS, OS, and safety profile. Safety was evaluated by measuring the occurrence and severity of adverse effects by National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0.

Being tested
Sacituzumab tirumotecan, Tagitanlimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab tirumotecanBiological

    Also called SKB264, sac-TMT

    Sacituzumab tirumotecan 5 mg/kg, intravenously (iv), Q2W

  • TagitanlimabBiological

    Also called KL-A167

    Tagitanlimab 900mg, intravenously (iv), Q2W

Study groups in NCT07109284
Study groupRoleWhat they receive
Sacituzumab Tirumotecan + TagitanlimabExperimentalParticipants receive Sacituzumab Tirumotecan every 2 weeks (q2w) in combination with Tagitanlimab every 2 weeks (q2w) for 18 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sacituzumab tirumotecan infusions.
Receives: Biological: Sacituzumab tirumotecan; Biological: Tagitanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0)

    No microscopically detectable remnants of aggressive tumors in breast and axillary lymph nodes, ductal carcinoma in situ is allowed

    Measured: Up to approximately 6 months (Time of surgery)

Secondary outcomes (5)

  1. pCR Rate (ypT0/Tis)

    No microscopically detectable remnants of aggressive tumors in breast, ductal carcinoma in situ is allowed.

    Measured: Up to approximately 6 months (Time of surgery)

  2. Objective response rate (ORR)

    The percentage of participants with CR or PR as the best response during the neoadjuvant treatment, based on RECIST v1.1.

    Measured: Up to approximately 6 months (Time of surgery)

  3. Event-Free Survival (EFS)

    The time from the first treatment to disease progression that: precludes surgery, results in a local or distant recurrence, results in a second primary malignancy, or death due to any cause whichever occurs first.

    Measured: Up to approximately 3 years

  4. Overall Survival (OS)

    The time from the date of first treatment to date of death due to any cause.

    Measured: Up to approximately 3 years

  5. Adverse events (AEs)

    Evaluated by NCI CTCAE (version 5.0) :

    1. The incidence, severity, and correlation with the investigational drug of adverse events (AE), treatment-related adverse events (TRAE), and serious adverse events (SAE);
    2. The number and proportion of subjects who reduced their dosage and stopped treatment due to the aforementioned adverse events;
    3. Study the changes in vital signs, physical examination results, and laboratory results before, during, and after treatment.

    Measured: Up to approximately 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionJan 2028 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109284
Sponsor's protocol ID
SKB264-IIT-003
Acronym
NeoSaciA
Status last verified
Jul 2025
First submitted
31 Jul 2025
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sacituzumab tirumotecan and Tagitanlimab in people with ER+HER2- Breast Cancer, run by West China Hospital.

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 12 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: opening soon, as of the sponsor's last update on 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

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 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?

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?

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?

Pathological Complete Response (pCR) Rate (ypT0/Tis ypN0) (time frame: Up to approximately 6 months (Time of surgery)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07109284.

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 7 Aug 2025.

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