Clinical trial NCT04907344: Study of Camrelizumab Plus Chemotherapy as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC)
Official title: A Multicenter, Open, Randomized Controlled Study of Camrelizumab+ Nab-paclitaxel + Carboplatin Versus Nab-paclitaxel + Carboplatin as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Triple Negative Breast Cancer
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2021-05-28
Enrollment: 420
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in Combination With Nab-Paclitaxel and carboplatin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC).


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed breast cancer;
* 18-75 Years, female;
* ECOG Performance Status of 0-1;
* Life expectancy is not less than 3 months;
* Histologically documented TNBC (negative human epidermal growth factor receptor 2 \[HER2\], estrogen receptor \[ER\], and progesterone receptor \[PgR\] status);
* Tumor stage: II-III;
* At least one measurable lesion according to RECIST 1.1;
* Adequate hematologic and organ function.;
* Must be willing to use an adequate method of contraception for the course of the study.

Exclusion Criteria:

* Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer;
* Inflammatory breast cancer;
* Has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy, radiation therapy, immunotherapy, biotherapy and TACE;
* 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., cytotoxic T-lymphocyte-associated antigen-4 \[CTLA-4\];
* 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;
* Major surgical procedure within 4 weeks prior to initiation of study treatment;
* Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus;
* Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases;
* Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study;
* Has a known history of Human Immunodeficiency Virus (HIV);
* Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis;
* Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia;
* Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment;
* Has evidence of active tuberculosis within 1year prior to initiation of study treatment;
* Prior allogeneic stem cell or solid organ transplantation;
* Pre-existing motor or sensory neuropathy of a severity≥grade 2;
* Has significant cardiovascular disease;
* Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
* Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
* History of neurological or psychiatric disorders, including epilepsy or dementia;
* Any other situation evaluated by researchers.

Primary outcomes:
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
timeFrame: Up to approximately 24 weeks
Secondary outcomes:
measure: pCR rate using the definition of 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
timeFrame: Up to approximately 24 weeks
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 24 weeks
measure: Event-Free Survival (EFS)
timeFrame: Up to approximately 5 years
measure: Invasive Disease-Free Survival (iDFS)
timeFrame: Up to approximately 5 years
measure: Overall survival (OS)
timeFrame: Up to approximately 5 years
measure: Adverse events (AEs)
timeFrame: Up to approximately 35 weeks
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Breast Cancer Department I, Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
city: Tianjin
country: China
facility: Breast Oncology, Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
affiliation: Breast Oncology, Tianjin Medical University Cancer Institute and Hospital
name: Zhongsheng Tong, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Breast Cancer Department I, Tianjin Medical University Cancer Institute and Hospital
name: Xuchen Cao, MD
role: PRINCIPAL_INVESTIGATOR
References: