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Triple-negative Breast CancerPhase 2NeoATCTNCT04914390

A Phase Ⅱ Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer

A Phase 2 study testing AT regimen, Tislelizumab and Anlotinib in people with Triple-negative Breast Cancer, run by Sichuan Provincial People's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a prospective, single-arm and open-label phase II study, evaluating the efficacy and safety of anlotinib combined with tislelizumab and AT regimen as neoadjuvant treatment for triple-negative breast cancer. Participants will undergo/receive PDL1 testing after enrollment. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
AT regimen, Tislelizumab and Anlotinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
15 Sep 2023to 30 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has newly diagnosed, locally advanced TNBC, as defined by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines.
  • Age 18-75 years, female patients
  • ECOG performance status ≤1
  • Has previously untreated locally advanced non-metastatic (M0) TNBC defined as the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee of Cancer (AJCC) staging criteria for breast cancer as assessed by the investigator based on radiological and/or clinical assessment:T1c, N1-N2、T2, N0-N2、T3, N0-N2、T4a-d, N0-N2
  • Demonstrates adequate organ function:
  • Patients did not receive blood, platelet transfusion or growth factor support treatment within 14 days before blood sample collection in the screening period, and needed to meet:
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  • Hemoglobin（HB）>= 9g / dL;
  • The absolute value of neutrophil（ANC）>= 1.5 x 10^9/L;
  • Platelets（PLT）>= 100 x 10^9/L;
  • The biochemical inspection must meet the following indicators:
  • Serum creatinine（Cr）<= 1.5 ULN, or creatinine clearance（CCr）>= 60mL / min;
  • Total bilirubin（TBIL）<= 1.5 ULN, Or total bilirubin>1.0 ULN but direct bilirubin <= 1.0 ULN;
  • AST and ALT <= 2.5 ULN.
  • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through >= 120 days after the last dose of study treatment, and have a negative serum pregnancy test <= 7 days before the first administration of the study drug.

Who cannot join

  • Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
  • Has received prior chemotherapy, targeted therapy, and radiation therapy within the past 12 months.
  • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or antiangiogenic drug therapy.
  • Patients who are known to be allergic to Tislelizumab, Anlotinib, nab-paclitaxel or Anthracyclines;
  • Has multiple factors affecting oral medication. Such as inability to swallow, chronic diarrhea and intestinal obstruction;
  • Patients with any severe and/or uncontrolled disease, including:
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  • Patients whose blood pressure control is not ideal (systolic pressure >= 150 mmHg, diastolic pressure >= 100 mmHg);
  • Having grade I or above myocardial ischemia or infarction, arrhythmia (including QTc >= 450ms(male) or QTc >= 470ms(female) and grade >= 2 congestive heart failure (New York Heart Association (NYHA) classification);
  • Active or uncontrolled severe infection;
  • Antiviral treatment for cirrhosis, decompensated liver disease, active hepatitis or chronic hepatitis;
  • Renal failure requires hemodialysis or peritoneal dialysis;
  • A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a History of organ transplantation;
  • Poor control of diabetes mellitus (FBG) > 10mmol/L;
  • Urine routine indicated urinary protein >= ++, and confirmed 24-hour quantitative urinary protein > 1.0g;
  • Patients with epileptic seizures requiring treatment;
  • Patients whose tumors have invaded around important blood vessels according to imaging findings or whose tumors are likely to invade important blood vessels or whose tumors are obviously necrotic and cause fatal massive hemorrhage according to the judgment of the researchers during the follow-up study;
  • Patient has experienced A number of thrombosis events, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism within 6 months;
  • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months;
  • Regardless of the severity, patients with any physical signs or history of bleeding, patients with bleeding or bleeding events greater than or equal to CTCAE 3 within four weeks prior to the first administration, or patients with unhealed wounds, fractures, gastric and duodenal active ulcers, ulcerative colitis, or unresected tumors have active bleeding, or may be caused as determined by the researchers. Other conditions of gastrointestinal bleeding and perforation;
  • Uncontrolled pleural effusion, pericardial effusion and peritoneal effusion requiring repeated drainage;
  • Patients who have participated in clinical trials of other drugs within 4 weeks; Concomitant diseases that, according to the investigator's judgment, may seriously endanger the patient's safety or affect the patient's completion of the study.

Trial locations and contacts

1 site in 1 country.

Jing Luo, Prof. contact

86-18981838521

luckyluojingyu@163.com

China1 site, 1 recruiting

  • Department of breast surgery, Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610031

    Prof.Chenjie, 86-18628263734, 344562821@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Open, Single-arm, Phase Ⅱ Clinical Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer

This is a prospective, single-arm and open-label phase II study, evaluating the efficacy and safety of anlotinib combined with tislelizumab and AT regimen as neoadjuvant treatment for triple-negative breast cancer. Participants will undergo/receive PDL1 testing after enrollment. All patients will be receive 6 cycles of low-dose anlotinib combined with tislelizumab and AT（Doxorubicin or Epirubicin+albumin-bound paclitaxel）regimen, followed by surgery.

Being tested
AT regimen, Tislelizumab, Anlotinib
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

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

  • AT regimenDrug

    Also called Anthracycline/Nab-paclitaxel

    Doxorubin 60mg/㎡ d1 or Epirubicin 75mg/㎡ d1 and Nab-paclitaxel 260mg/㎡ d1 of Cycles 1-6 (Q3W) of the neoadjuvant phase of the study; IV injection.

  • TislelizumabDrug

    Also called BGB-A317

    200mg on d1 of Cycles 1-6 (Q3W) of the neoadjuvant phase of the study; IV injection.

  • AnlotinibDrug

    Also called AL3818

    8mg on d1-14 of Cycles 1-5 (Q3W) of the neoadjuvant phase of the study; po. Arotinib is a small molecule multi-target TKI, which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.

Study groups in NCT04914390
Study groupRoleWhat they receive
Tislelizumab + Anlotinib + ChemotherapyExperimentalParticipants receive Tislelizumab every 3 weeks (Q3W) + Anlotinib d1-14 (Q3W) + AT regimen (Q3W) x 6 cycles as neoadjuvant therapy prior to surgery.
Receives: Drug: AT regimen; Drug: Tislelizumab; Drug: Anlotinib

What is being measured

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

  1. Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery

    pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

    Measured: up to approximately 21-24 weeks

Secondary outcomes (6)

  1. Event-free Survival (EFS) as assessed by Investigator

    EFS is defined as the time from randomization to any of the following events: progression of disease that precludes surgery, local or distant recurrence, second primary malignancy (breast or other cancers) or death due to any cause.

    Measured: Up to approximately 3 years

  2. pCR rate using an alternative definition, ypT0 ypN0 (i.e., no invasive or noninvasive residual in breast or nodes) at the time of definitive surgery

    pCR rate (ypT0 ypN0) is defined as the percentage of participants without residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants and in participants with tumors expressing Programmed Death-Ligand 1 (PD-L1).

    Measured: up to approximately 21-24 weeks

  3. pCR rate using an alternative definition, ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery

    pCR rate (ypT0/Tis) is defined as the percentage of participants without invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants and in participants with tumors expressing PD-L1.

    Measured: up to approximately 21-24 weeks

  4. invasive disease-free survival(IDFS)

    The time from surgery to the first documented occurrence of an event defined as ipsilateral invasive local recurrence, ipsilateral locoregional invasive recurrence, distant recurrence, contralateral invasive breast cancer, or death from any cause

    Measured: up to approximately 3 years

  5. Overall survival (OS)

    OS is defined as the time from randomization to death due to any cause. Participants without documented death at the time of the analysis will be censored at the date of the last follow-up.

    Measured: up to approximately 5 years

  6. Percentage of participants who experience an adverse event (AE)

    An AE is defined as any untoward medical occurrence in a participant administered study treatment which does not necessarily have to have a causal relationship with this treatment. An AE can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of study treatment, is also an AE.

    Measured: up to approximately 60 weeks

Timeline

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

  1. First posted4 Jun 2021
  2. Study start15 Sep 2023
  3. Primary completion31 Mar 2025 (estimated)
  4. Study completion30 Sep 2025 (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
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04914390
Sponsor's protocol ID
ALTERBC008
Acronym
NeoATCT
Status last verified
Jan 2024
First submitted
31 May 2021
Last updated
22 Jan 2024
Results posted
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 AT regimen, Tislelizumab and Anlotinib in people with Triple-negative Breast Cancer, run by Sichuan Provincial People's 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 14 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 22 Jan 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. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jing Luo, Prof. (86-18981838521, luckyluojingyu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery (time frame: up to approximately 21-24 weeks). 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 NCT04914390.

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 22 Jan 2024.

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