Neoadjuvant Camrelizumab Plus Chemotherapy in Triple Negative Breast Cancer

NCT05088057 | Unknown Phase 2

• 1 other identifier: 2021-TNBC-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Camrelizumab plus chemotherapy as neoadjuvant therapy and Camrelizumab as adjuvant therapy in participants who have triple negative breast cancer (TNBC).

Conditions

Triple Negative Breast Cancer (TNBC)

Keywords

Camrelizumab; Chemotherapy; Neoadjuvant; PD-1

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR)

  pCR rate 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

  Up to approximately 12-30 weeks

Secondary Outcomes (4)

• Event-Free Survival (EFS)

  Up to approximately 2 years

• Objective Overall Response Rate (ORR)

  [Time Frame: Up to approximately 12-30 weeks]

• Overall survival (OS)

  Up to approximately 2 years

• Adverse events (AEs)

  Up to approximately 35 weeks

Other Outcomes (1)

• End point of exploratory study

  Up to approximately 35 weeks

Study Arms (1)

Camrelizumab+Chemotherapy

EXPERIMENTAL

PD-1+AC-T: Participants receive Camrelizumab Q3W + doxorubicin Q3W + cyclophosphamide Q3W for 4 cycles, followed by Camrelizumab Q3W + docetaxel Q3W for 4 cycles as neoadjuvant therapy prior to surgery,followed by 9 cycles of Camrelizumab Q3W as adjuvant therapy post-surgery. PD-1+TA: Participants receive Camrelizumab Q3W for 8 cycles , docetaxel Q3W + doxorubicin Q3W for 4 cycles as neoadjuvant therapy prior to surgery,followed by 9 cycles of Camrelizumab Q3W as adjuvant therapy post-surgery.

Drug: Camrelizumab; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Docetaxel

Interventions

Camrelizumab DRUG

200mg on Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles (Q3W), intravenous (IV) infusion.

Camrelizumab+Chemotherapy

Doxorubicin DRUG

60mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.

Camrelizumab+Chemotherapy

Cyclophosphamide DRUG

600 mg/m² on Day 1 of Cycles 1-4 (Q3W)of the neoadjuvant phase of the study, IV infusion.

Camrelizumab+Chemotherapy

Docetaxel DRUG

75mg/m² on Day 1 of Cycles 1-4 (Q3W) or Cycles 5-8 (Q3W) of the neoadjuvant phase of the study, IV infusion;

Camrelizumab+Chemotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years, female;
• Histologically documented Triple Negative Breast Cancer (TNBC) patients;
• The subtypes of TNBC patients should include basal cell-like subtypes (BL1, BL2), Luminal androgenic type (LAR), and other types, such as mesenchymal type (M), mesenchymal stem cell type (MSL) and immunomodulatory type (IM);
• Previously untreated non-metastatic (M0) TNBC, the primary tumor (T) and regional lymph node (N) combined staging determined by the investigator based on radiological and/or clinical evaluation. Stage at presentation: T1c, N1-N2; T2, N0-N2; T3, N0-N2;
• Promising radical surgical treatment;
• At least one measurable lesion according to RECIST 1.1;
• Life expectancy is not less than 3 months;
• ECOG: 0～1;
• Adequate function of major organs meets the following requirements:
• Neutrophils ≥ 1.5×10\^9/L Hemoglobin ≥ 90g/L Platelets ≥ 100×10\^9/L Total bilirubin≤ 1.5 × the upper limit of normal (ULN) ALT and AST ≤ 2.5 × ULN Serum creatinine ≤1.5 × ULN, Endogenous creatinine clearance ≥50mL/min;
• Left ventricular ejection fraction (LVEF) ≥50% or ≥ limit of normal (LLN) was evaluated by echocardiography (ECHO) or Multigated Acquisition (MUGA);
• Women with childbearing potential who are must agree to take effective contraceptive measures during the study period and ≥120 days after the last administration of the study drug, and must have a negative serum pregnancy test result within 7 days prior to initiation of study drug.
• The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with follow-up;

You may not qualify if:

• Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment;
• Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies;
• 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;
• 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, including pulmonary fibrosis, acute lung disease, etc.;
• Administration of a live attenuated vaccine within 30 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study;
• Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment;
• Has a history of serious cardiovascular disease, including myocardial infarction, acute coronary syndrome or coronary angioplasty/stent implantation/bypass grafting history in the past 6 months, and have level II-IV congestion Heart failure (CHF), or III NYHA and IV CHF history;
• Prior allogeneic stem cell or solid organ transplantation
• History of neurological or psychiatric disorders, including schizophrenia, severe depressive disorder, bipolar disorder, etc.;
• Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first administration of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• History of severe hypersensitivity reactions to other monoclonal antibodies, or intravenous infusion, or Doxorubicin, or cyclophosphamide, or docetaxel;
• 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;
• Any other situation evaluated by researchers.

Sponsors & Collaborators

• Aiping Shi: lead

Study Sites (1)

Aiping Shi

Changchun, Jilin, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; Doxorubicin; Cyclophosphamide; Docetaxel

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes

Study Officials

• Aiping Shi, PhD

  The First Hospital of Jilin University

  STUDY DIRECTOR

Central Study Contacts

Aiping Shi, PhD

CONTACT

15804301451; 13364308696@163.com; 1172694608@qq.com; kjkzhaoliyuan@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: The First Hospital of Jilin University

Study Record Dates

• First Submitted: October 11, 2021
• First Posted: October 21, 2021
• Study Start: September 20, 2021
• Primary Completion: August 19, 2024
• Study Completion: November 1, 2024
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)