Study of Tislelizumab Plus Chemotherapy vs Chemotherapy as Perioperative Treatment in Participants With HER2 Negative Breast Cancer
NCT ID: NCT04498793
Last Updated: 2020-09-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
55 participants
INTERVENTIONAL
2020-09-30
2022-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PD-1 group
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.
Tislelizumab
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.
Nab paclitaxel
On Days 1 and 8 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
Doxorubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Cyclophosphamide
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
Control group
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.
Nab paclitaxel
On Days 1 and 8 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
Doxorubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Cyclophosphamide
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
Interventions
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Tislelizumab
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.
Nab paclitaxel
On Days 1 and 8 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
Doxorubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Epirubicin
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
Cyclophosphamide
On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
Eligibility Criteria
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Inclusion Criteria
* Provides a core needle biopsy consisting of at least 2 separate tumor cores from the primary tumor at screening to the central laboratory.
* Immune active subtype revealed by multiplexed
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of treatment initiation.
* Demonstrates adequate organ function.
Exclusion Criteria
* Has received prior chemotherapy, targeted therapy, or radiation therapy for breast cancer.
* Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs).
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (i.e. dosing exceeding 10 mg daily of prednisone or equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
* Has a known history of Human Immunodeficiency Virus (HIV).
* Has known active Hepatitis B or Hepatitis C.
* Has a known history of active tuberculosis.
* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
* Has an active infection requiring systemic therapy.
* Has significant cardiovascular disease, such as: history of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months OR congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
* Pregnant or lactating women are ineligible.
18 Years
ALL
No
Sponsors
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First Affiliated Hospital Xi'an Jiaotong University
OTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Beijing Huanxing Cancer Hospital
OTHER
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Ma Fei，MD
Principal Investigator
Locations
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Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Beijing Huanxing Cancer Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Other Identifiers
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NCC2474
Identifier Type: -
Identifier Source: org_study_id
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