Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Doxorubicin

Liposomal doxorubicin

Tislelizumab

Albumin-Bound Paclitaxel

Epirubicin

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

Participants receive Tislelizumab every 3 weeks (Q3W) + Anlotinib d1-14 (Q3W) + AT regimen (Q3W) x 6 cycles as neoadjuvant therapy prior to surgery.

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.

AT regimen

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

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.

Anlotinib

Jing Luo, Prof.

Prof.Chenjie

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.

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

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

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.

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.

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).

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.

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

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.

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.

Sichuan Provincial People's Hospital

Prof.

Docetaxel

Carboplatin

Cisplatin

Participants receive AT regimen for neoadjuvant therapy

Participants receive TP regimen for neoadjuvant therapy

Doxorubin 60mg/㎡ d1 or Epirubicin 75mg/㎡ d1 Docetaxel 75mg/㎡ d1 1/21d

Albumin paclitaxel 125mg/㎡ d1, 8 Cisplatin 75mg/㎡ d1-3 1/21d✖6 or carboplatin AUC6 d1 1/21d✖6

TP regimen

Prof. Luojing

This is a prospective, randomized and open-label phase II study, evaluating the efficacy and safety of AT vs TP regimen as neoadjuvant treatment for early HER2-negative breast cancer. Participants will undergo/receive HRD testing after enrollment. HRD-positive patients will be randomly assigned in a ratio of 1:1 to receive AT（Doxorubicin or Epirubicin+docetaxel）or TP（Albumin paclitaxel + Cisplatin or Carboplatin）regimen respectively, followed by surgery. HRD-negative patients will be assigned to receive TP（Albumin paclitaxel + Cisplatin or Carboplatin）regimen if TNBC, or AT（Doxorubicin or Epirubicin+docetaxel）rigemen, followed by surgery.

This study intends to adopt Simon's two-stage optimal design. In stage 1, 15 HRD-positive and 15 HRD-negative patients will be recruited to receive AT or TP regimen as neoadjuvant therapy. If more than 5 patients in the HRD-positive group achieve pCR(pathological complete response) , the trial expands to stage 2, otherwise the trial terminates. In stage 2, another 31 HRD- positive and 31 HRD-negative patients will be enrolled.

AT Versus TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer

A Randomized Phase 2 Trial to Assess the Efficacy of AT in Comparison to TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer : Evaluating the Homologous Recombination Deficiency(HRD) Biomarker

1. To compare the pathologic response to neoadjuvant AT regimen in HER2- breast cancer with and without HR-deficiency, defined as a high HRD score or a BRCA mutation
2. To compare the pathologic response to neoadjuvant TP regimen in HER2- breast cancer with and without HR-deficiency, defined as a high HRD score or a BRCA mutation
3. To compare the pathologic response to neoadjuvant AT vs TP regimen in HER2- breast cancer with HR-deficiency, defined as a high HRD score or a BRCA mutation

To determine the response rates of the breast tumor and axillary nodes based on imaging tests. (sonography, mammography, or MRI) after treatment.

RCB in the breast tissue and the lymph node tissue will be performed after the completion of neoadjuvant systemic therapy.

To assess the pCR rate in HRD high with vs without tBRCA mutation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase Ⅱ Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer	NCT04914390	Triple-negative...	AT regimen Tislelizumab Anlotinib	18 Years - 75 Years	Sichuan Provincial People's Hospital
AT Versus TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer	NCT04499118	HER2-negative B...	AT regimen TP regimen	18 Years -	Sichuan Provincial People's Hospital
AT Versus TP as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer	NCT04499118	HER2-negative B...	AT regimen TP regimen	18 Years -	Sichuan Provincial People's Hospital
A Phase Ⅱ Study of Anlotinib Combined With Tislelizumab and AT in the Neoadjuvant Treatment of Triple-negative Breast Cancer	NCT04914390	Triple-negative...	AT regimen Tislelizumab Anlotinib	18 Years - 75 Years	Sichuan Provincial People's Hospital

Spots Global Cancer Trial Database for at regimen

Every month we try and update this database with for at regimen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for at regimen

Every month we try and update this database with for at regimen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for at regimen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.