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Breast CancerPhase 2NCT07896668

Pucotenlimab and Anlotinib in Combination With Chemotherapy

A Phase 2 study testing LP in people with Breast Cancer, run by Zhejiang Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A prospective, multicenter, single-arm clinical study enrolling patients with histologically confirmed invasive carcinoma, clinical stage II-III, known PD-L1 status, and treatment-naïve triple-negative breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
LP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteChina
Study dates
1 Sep 2025to 1 Sep 2032
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation and signed informed consent.
  • Age ≥ 18 years, male or female.
  • Histologically confirmed invasive breast carcinoma with documented ER-negative, PR-negative, and HER2-negative status, defined as:
  • ER and PR: nuclear staining < 10% by IHC;
  • HER2: 0 or 1+ by IHC, or 2+ with negative FISH amplification.
  • Known PD-L1 status.
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  • Assessed by breast surgeon as eligible and planned for radical mastectomy.
  • Clinical stage II-III per AJCC 8th edition and at least one measurable lesion per RECIST v1.1.
  • No prior systemic therapy for the current disease, including surgery, radiotherapy, chemo/immunotherapy, etc.
  • ECOG performance status 0-1.
  • Adequate hematologic and organ function, as defined by:
  • Absolute neutrophil count ≥ 1.5 × 10⁹/L;
  • Platelet count ≥ 100 × 10⁹/L;
  • Hemoglobin ≥ 90 g/L;
  • Total bilirubin ≤ 1.5 × ULN;
  • AST, ALT, and ALP ≤ 2.5 × ULN;
  • Serum creatinine ≤ 1.5 × ULN or creatinine clearance (Cockcroft-Gault formula) ≥ 50 mL/min.
  • Adequate cardiac function:
  • NYHA class < 3;
  • Left ventricular ejection fraction (LVEF) ≥ 50%.
  • Life expectancy ≥ 3 months.
  • Contraceptive requirements:
  • Female patients: surgically sterile, postmenopausal, or agree to use at least one medically approved contraceptive measure (e.g., IUD, oral contraceptives, condoms) during and for 6 months after the treatment period; negative serum/urine pregnancy test within 7 days prior to enrollment; not lactating.
  • Male patients: agree to use at least one medically approved contraceptive measure (e.g., condom, abstinence) during and for 6 months after the treatment period.
  • Willing and able to comply with study visits, procedures, prohibitions, and restrictions specified in the protocol.

Who cannot join

  • Stage IV (metastatic) TNBC.
  • History of invasive malignancy ≤ 5 years prior to informed consent, except adequately treated basal/squamous cell skin cancer or in situ cervical cancer.
  • Prior systemic anticancer therapy (including investigational agents) before planned start of study treatment.
  • Known hypersensitivity to pucotenlimab, nab-paclitaxel, or any of their components.
  • Active or history of autoimmune disease with potential for relapse (e.g., SLE, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, multiple sclerosis, vasculitis, glomerulonephritis) or high risk (e.g., organ transplant requiring immunosuppressive therapy). Exceptions allowed for:
  • Type I diabetes mellitus stabilized on fixed insulin regimen;
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  • Autoimmune hypothyroidism on hormone replacement therapy only;
  • Skin conditions not requiring systemic therapy (e.g., eczema, rash involving < 10% BSA, psoriasis without ocular symptoms).
  • Major surgery, open biopsy, or significant trauma within 4 weeks prior to planned start of study treatment. Major surgery defined as requiring at least 3 weeks of recovery before study treatment.
  • History of allogeneic organ or hematopoietic stem cell transplantation.
  • Pregnant or lactating female patients.
  • Untreated acute/chronic active hepatitis B or hepatitis C infection. Exceptions:
  • HBV carriers or patients stabilized on antiviral therapy with HBV DNA ≤ 500 IU/mL or < 2500 copies/mL are allowed.
  • Active hepatitis C defined as positive anti-HCV antibody with quantifiable HCV RNA above the lower limit of detection.
  • Uncontrolled concurrent illness, including but not limited to:
  • HIV positive;
  • Active or poorly controlled severe infection;
  • Severe or uncontrolled systemic disease (e.g., severe psychiatric/neurological disorders, epilepsy/dementia, unstable or uncompensated respiratory, cardiovascular, hepatic, or renal disease);
  • Unstable systemic disease such as diabetes (fasting glucose ≥ 10 mmol/L) or hypertension (systolic BP > 150 mmHg or diastolic BP > 90 mmHg).
  • Active bleeding or new thrombotic disease on therapeutic anticoagulation, or bleeding diathesis.
  • Active tuberculosis.
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuan Huang contact

86571188122152

huangyuan@zjcc.org.cn

China1 site, 1 recruiting

  • Zhejiang Cancer Hospital

    Hangzhou

    Yuan Huang, 86571188122152, huangyuan@zjcc.org.cn

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Pucotenlimab and Anlotinib in Combination With Chemotherapy as Neoadjuvant Therapy in Early-stage Triple-negative Breast Cancer.

A prospective, multicenter, single-arm clinical study enrolling patients with histologically confirmed invasive carcinoma, clinical stage II-III, known PD-L1 status, and treatment-naïve triple-negative breast cancer. Patients will receive neoadjuvant therapy with pucotenlimab, anlotinib, and nab-paclitaxel, sequentially followed by epirubicin and cyclophosphamide, for a total of 8 cycles.

Conditions
Breast Cancer
Being tested
LP
Medical subject headings
Breast Neoplasms

What participants receive

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

  • LPDrug

    Neoadjuvant pucotenlimab, anlotinib plus nab-paclitaxel, sequentially followed by epirubicin/cyclophosphamide for 8 cycles.

Study groups in NCT07896668
Study groupRoleWhat they receive
Pucotenlimab and anlotinib in combination with chemotherapyExperimentalNot described
Receives: Drug: LP

What is being measured

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

  1. Total pathological complete response (tpCR) rate

    ypT0/Tis ypN0

    Measured: Within 30 days of definitive surgery

Secondary outcomes (8)

  1. Objective response rate (ORR)

    Measured: Prior to surgery

  2. Breast pathological complete response (bpCR) rate

    Measured: Within 30 days of definitive surgery

  3. tpCR rate in patients with PD-L1 expression

    Measured: Within 30 days of definitive surgery

  4. Event free survival (EFS)

    EFS is defined as the time from the date of first dose to the first occurrence of any of the following events: disease progression precluding curative-intent surgery, local or distant recurrence, or death from any cause. For participants without any events, EFS will be censored at the date of the last known event-free assessment.

    Measured: From date of first dose until the first documented event or up to 5 years

  5. Disease free survival (DFS)

    DFS is defined as the time from the date of surgery to the first occurrence of loco-regional or distant recurrence, or death from any cause. For participants without an event, DFS will be censored at the date of the last known disease-free assessment.

    Measured: From date of surgery up to 5 years

  6. Incidence of Adverse Events (AEs)

    Measured: Up to 30 days post-last dose (with 7-day window) or until new therapy/adjuvant therapy, whichever first.

  7. Health-Related Quality of Life Assessed by EORTC QLQ-C30

    Measured: at baseline and within 3 weeks after completion of the last neoadjuvant therapy cycle.

  8. Health-Related Quality of Life Assessed by EORTC QLQ-BR45

    Measured: at baseline and within 3 weeks after completion of the last neoadjuvant therapy cycle.

Timeline

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

  1. First posted27 Oct 2026
  2. Study start1 Sep 2025
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2032 (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
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07896668
Sponsor's protocol ID
LP2025
Status last verified
Oct 2026
First submitted
6 Sep 2026
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
Yes
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 LP in people with Breast Cancer, run by Zhejiang Cancer Hospital 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 25 inclusion and 22 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 27 Oct 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 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?

Contact Yuan Huang (86571188122152, huangyuan@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total pathological complete response (tpCR) rate (time frame: Within 30 days of definitive 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 NCT07896668.

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 Oct 2026.

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