Neoadjuvant Study of Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer (TNBC)

Sponsor
Shandong Cancer Hospital and Institute
Study ID
NCT04676997
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab — BIOLOGICAL
    200mg on days1,15 of Cycles 1-4 (Q2W); IV infusion. 200mg on day 1 of Cycles 5-8 (Q2W); IV infusion.
  • Nab paclitaxel — DRUG
    125 mg/m² on day 1, 8 and 15 of Cycles 1-4 (QW 3/4); IV infusion.
  • Epirubicin — DRUG
    90 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.
  • Cyclophosphamide — DRUG
    600 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.

Study Details

The study is being conducted to evaluate the efficacy, safety and tolerability of Camrelizumab Combination With Nab-Paclitaxel and Epirubicin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)

Key Dates

Start date
May 20, 2020
Status verified
Dec 2020
Primary completion
Jul 30, 2021
Completion
Feb 28, 2024

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab+Chemotherapy
    Participants receive Camrelizumab d1,15 (Q2W) + nab-paclitaxel d1,8,15(QW 3/4) x 4 cycles, followed by Camrelizumab Q2W + epirubicin + cyclophosphamide Q2W x 4 cycles as neoadjuvant therapy prior to surgery

Primary Outcome Measure

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 27-30 weeks ]

Central Contacts

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