A Phase 2 interventional study of Tislelizumab and Nab paclitaxel in HER2-negative Breast Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. Status unknown at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-03.
Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Phase 2, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of tislelizumab plus chemotherapy vs chemotherapy alone as perioperative treatment in participants who have triple negative HER2 negative breast cancer.
After a screening phase of approximately 28 days, each participant will receive neoadjuvant study treatment (Tislelizumab + Chemotherapy OR Chemotherapy) based on the randomization schedule for approximately 24 weeks (8 cycles). Each participant will then undergo definitive surgery 3-6 weeks after conclusion of the last cycle of the neoadjuvant study treatment.
After definitive surgery, each participant will receive adjuvant study treatment (routine adjuvant treatment +/- Tislelizumab) for approximately 42 weeks (14 cycles).
Following adjuvant study treatment, each participant will be monitored for safety, survival and disease recurrence.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 55 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Cancer Institute and Hospital, Chinese Academy of Medical Sciences is the lead sponsor of 373 studies on the registry; 270 are open to participants now.
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Exclusion Criteria:
Participants receive tislelizumab every 3 weeks (Q3W) + nab-paclitaxel weekly x 4 cycles, followed by tislelizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 14 cycles of tislelizumab Q3W plus capecitabine (TNBC subtype) or endocrine therapy (Luminal subtype) as adjuvant therapy post-surgery. Each cycle is 21 days.
Biological: Tislelizumab · Drug: Nab paclitaxel · Drug: Doxorubicin · Drug: Epirubicin · Device: Cyclophosphamide
Participants receive nab-paclitaxel weekly x 4 cycles followed by (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by capecitabine (TNBC subtype) or endocrine therapy (Luminal subtype) as adjuvant therapy post-surgery. Each cycle is 21 days.
Drug: Nab paclitaxel · Drug: Doxorubicin · Drug: Epirubicin · Device: Cyclophosphamide
On Day 1 of the last seven cycles in the neoadjuvant and each cycle in the adjuvant phases of the study for a total of 21 cycles; intravenous (IV) infusion.
On Days 1 and 8 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
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.
Time frame: Up to 30 weeks
This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences