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Breast NeoplasmsPhase 3NCT06313463

Study Of Capecitabine Combined With Camrelizumab For Non-pCR TNBC With TLS After Neoadjuvant Chemoterapy

A Phase 3 study testing Carrellizumab + Capecitabine in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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
Search all trials

Trial summary

This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy… Read more about this study

Who is it for?
Ages 18 to 80 years, women only
Conditions the study is for
Breast Neoplasms
What is being tested?
Carrellizumab + Capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
375 participants
Where
1 siteChina
Study dates
Mar 2024to Dec 2035
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 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent form.
  • Female patients aged ≥18 years at the time of signing informed consent.
  • Patients with adequate cognitive ability and willingness to understand and comply with the treatment and follow-up plans as required by the study protocol.
  • Confirmed invasive breast cancer on histological examination.
  • Clinical stage at presentation: cT4/any N/M0, any cT/N2-3/M0, or cT1-3/N0-1/M0 (patients with cT1mi/T1a/T1b/N0 are not eligible).
  • Confirmation of TNBC diagnosis and TLS and PD-L1 status through central examination of representative tumor tissue specimens resected during surgery.
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  • Patients with synchronous bilateral invasive disease or multicentric tumors (involving more than one quadrant) are eligible for the study, provided that all discrete lesions are confirmed by the central laboratory as TNBC and TLS-positive. For patients with multifocal tumors (more than one mass involving the same quadrant), sampling must be performed on at least one lesion, confirmed by the central laboratory as TNBC and TLS-positive.
  • For patients with multifocal or multicentric breast cancer, measurement of the largest lesion to determine the T stage is required.
  • Confirmation of TNBC and prospective assessment of TLS presence in tumor tissue before study enrollment, confirmed by HE staining and immunofluorescence staining. TLS positivity is defined as the presence of CD3+ and CD20+ cell aggregates identified by HE staining or immunofluorescence staining on tumor tissue or peritumoral tissue sections.
  • Completion of preoperative systemic chemotherapy and camrelizumab treatment.
  • Pathological assessment after neoadjuvant treatment did not achieve pCR.
  • Adequate resection: Complete removal of all clinically evident lesions in the breast and lymph nodes.
  • Interval between the date of initial surgery and randomization date not exceeding 12 weeks.
  • Eastern Cooperative Oncology Group performance status score of 0 or 1.
  • Completion of neoadjuvant therapy with echocardiography or multi-gated acquisition scan showing left ventricular ejection fraction (LVEF) ≥50% during the screening period and an absolute decrease in LVEF compared to pre-chemotherapy LVEF not exceeding 15%. Alternatively, if LVEF assessment was not performed pre-chemotherapy, LVEF must be ≥55% during the screening period post-neoadjuvant therapy.
  • Life expectancy ≥6 months.
  • Adequate hematological and organ function.
  • Negative HIV test result during screening, with the following exceptions: patients with positive HIV test results during screening are eligible to participate in the study, provided they receive stable antiretroviral therapy, have a CD4 count ≥200/µL, undetectable viral load, and no history of AIDS-defining opportunistic infections within 12 months prior to randomization. Investigators should consider potential drug interactions between study treatment and antiretroviral therapy before patient enrollment.
  • Negative hepatitis B surface antigen (HBsAg) test result during screening.
  • Negative hepatitis C virus (HCV) antibody test result during screening, or positive HCV antibody test result during screening, followed by negative HCV RNA test result.
  • For women of childbearing potential: agreement to practice abstinence (no heterosexual intercourse) or use contraception, and agreement not to donate eggs.

Who cannot join

  • Stage IV (metastatic) breast cancer
  • Inadequate resection (as described in the inclusion criteria)
  • At the end of preoperative systemic therapy, the overall response assessment by the researchers resulted in disease progression.
  • Patients recommended for radiotherapy for breast cancer but contraindicated due to medical reasons (e.g., connective tissue diseases or prior radiation to the ipsilateral breast).
  • Presence of another malignant tumor within the last 5 years before screening (excluding appropriately treated cervical carcinoma in situ, non-melanoma skin cancer, Stage I endometrial carcinoma, or DCIS).
  • Prior use of CD137 agonists or immune checkpoint inhibitors, including anti-cytotoxic T-lymphocyte-associated protein 4, anti-PD-1, and anti-PD-L1 therapeutic antibodies.
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  • Current presence of ≥ Grade 2 peripheral neuropathy (according to NCI CTCAE v5.0).
  • Dyspnea at rest.
  • Presence of any of cardiopulmonary dysfunction.
  • Current or past history of autoimmune disease or immunodeficiency.
  • Idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonia, or history of idiopathic pneumonia or evidence of active pneumonia.
  • Active tuberculosis.
  • History of severe, uncontrolled systemic diseases (e.g., clinically significant cardiovascular, pulmonary, or metabolic diseases; impaired wound healing; ulcers).
  • Known active liver disease, such as autoimmune hepatitis or sclerosing cholangitis.
  • Receipt of major surgery within 4 weeks before randomization (excluding breast cancer surgery) or anticipated need for major surgery during the study.
  • Occurrence of severe infection within 4 weeks before randomization, including but not limited to hospitalization due to complications of infection, sepsis, or severe pneumonia, SARS-CoV-2 infection, or any active infection deemed likely to affect patient safety by the investigator.
  • Receipt of therapeutic antibiotics by intravenous injection within 2 weeks or oral antibiotics within 5 days before randomization.
  • Previous allogeneic bone marrow or solid organ transplantation.
  • Contraindication to experimental drugs or any other diseases, metabolic disorders, physical examination findings, or clinical laboratory findings that may affect the interpretation of results or may put the patient at high risk of treatment-related complications.
  • Receipt of a live attenuated vaccine within 4 weeks before randomization or anticipated need for such a vaccine during the study treatment period or within 5 months after the last dose of treatment.
  • Receipt of experimental treatment within 28 days before randomization.
  • Receipt of systemic immunostimulatory agents (including but not limited to interferons and IL-2) within 4 weeks before randomization or within 5 half-lives of the drug (whichever is longer).
  • Receipt of systemic immunosuppressive medications (including but not limited to corticosteroids, azathioprine, methotrexate, salicylates, and anti-tumor necrosis factor-alpha [TNF-α] agents) within 2 weeks before randomization or anticipated need for systemic immunosuppressive medications during the study treatment period.
  • Previous severe hypersensitivity/allergic reaction to chimeric or humanized antibodies or fusion proteins.
  • Known severe hypersensitivity to any component of the drug.
  • Pregnancy or lactation, or planning to become pregnant within 6 months after the end of the study treatment period.

Trial locations and contacts

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

Shicheng Su contact

+86 13631304227

sushch@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510120

    Shicheng Su, M.D., Ph.D., +86 13632394954, lnl_trial@126.com

    Erwei Song, M.D., Ph.D., +86 13719237746, lnl_trial@126.com

    Recruiting

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled, Phase III Study to Evaluate the Efficacy and Safety of Camrelizumab and Capecitabine Versus Capecitabine as Adjuvant Therapy in Early-stage Triple-negative Breast Cancer Patients With Tertiary Lymphoid Structure in Tumor Who Have Residual Tumor in the Breast or Axillary Lymph Nodes Following Neoadjuvant Chemotherapy.

This study aims to evaluate the efficacy and safety of camrelizumab in combination with capecitabine compared to placebo in combination with capecitabine as adjuvant therapy for patients with triple-negative breast cancer (TNBC) who have not achieved pathological complete response (pCR) after neoadjuvant chemotherapy and have tertiary lymphoid structures (TLS) in the tumor tissue. The primary endpoint of this study is disease-free survival (DFS) to assess the long-term effectiveness of the treatment. Secondary endpoints include invasive disease- free survival (IDFS), overall survival (OS), distant recurrence-free interval (DRFI), as well as safety and patient-reported outcomes. These endpoints will comprehensively evaluate the effectiveness of the treatment and the overall survival status of the patients.

The study anticipates a total sample size of 375 patients, who will be randomly assigned to either the experimental group or the control group. The experimental group will receive 8 cycles of adjuvant therapy of capecitabine and camrelizumab. The control group will receive 8 cycles of adjuvant therapy with capecitabine and placebo. This study aims to investigate whether non-pcr breast cancer patients with TLS in tumors can benefit from the adjuvant immunotherapy.

Being tested
Carrellizumab + Capecitabine, Placebo + Capecitabine
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Carrellizumab + CapecitabineDrug

    Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Carrellizumab 200mg IV D1（Q3W），8 cycles in total

  • Placebo + CapecitabineDrug

    Capecitabine 1000-1250mg/m2 PO bid D1-14（Q3W）+ Placebo 200mg IV D1（Q3W），8 cycles in total

Study groups in NCT06313463
Study groupRoleWhat they receive
Camrelizumab groupExperimentalNot described
Receives: Drug: Carrellizumab + Capecitabine
Placebo groupPlacebo comparatorNot described
Receives: Drug: Placebo + Capecitabine

What is being measured

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

  1. Disease-Free Survival

    Time from randomization to the first occurrence of any of the following events: local recurrence, distant metastasis, contralateral breast cancer, or death from any cause.

    Measured: 3 years

Secondary outcomes (6)

  1. Invasive Disease-Free Survival

    Time from randomization to the occurrence of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause.

    Measured: 3 years

  2. Overall Survival

    Time from randomization to death from any cause.

    Measured: 3 years

  3. Distant Recurrence-Free Interval

    Time from randomization to the date of distant breast cancer recurrence.

    Measured: 3 years

  4. Patient-reported outcomes-Proportion of patients in each group experiencing clinically meaningful deterioration

    Proportion of patients in each group experiencing clinically meaningful deterioration (defined as a decrease of 10 points or more in standardized scores) in global health status/quality of life (GHS/QoL), physical, role, and cognitive functioning measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) scale.

    Measured: 3 years

  5. Patient-reported outcomes-EORTC QLQ-C30 scores after treatment

    Mean absolute scores in GHS/QoL, physical, role, and cognitive functioning evaluated using EORTC QLQ-C30.

    Measured: 3 years

  6. Patient-reported outcomes-EORTC QLQ-C30 scores changes

    Percentage of score changes from baseline in GHS/QoL, physical, role, and cognitive functioning evaluated using EORTC QLQ-C30.

    Measured: 3 years

Timeline

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

  1. First posted15 Mar 2024
  2. Study startMar 2024 (estimated)
  3. Primary completionSep 2031 (estimated)
  4. Study completionDec 2035 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
375 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06313463
Sponsor's protocol ID
SYSKY-2023-1282-02
Status last verified
Mar 2024
First submitted
6 Mar 2024
Last updated
15 Mar 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Carrellizumab + Capecitabine in people with Breast Neoplasms, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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 21 inclusion and 26 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 15 Mar 2024. 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. Some participants in this study may receive a placebo. 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 Shicheng Su (+86 13631304227, sushch@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-Free Survival (time frame: 3 years). 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 NCT06313463.

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 15 Mar 2024.

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