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

NCT04676997 | Unknown Phase 2

• 1 other identifier: MA-BC-II-006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Triple Negative Breast Cancer

Keywords

Neoadjuvant; PD-1

Outcome Measures

Primary Outcomes (1)

• 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 tumor on hematoxylin and eosin evaluation of breast specimen and all sampled regional lymph nodes 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 27-30 weeks

Secondary Outcomes (4)

• 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

  Up to approximately 27-30 weeks

• Event-Free Survival (EFS) in all participants

  Up to approximately 5 years

• Objective Overall Response Rate (ORR)

  Up to approximately 25-30 weeks

• Adverse events (AEs)

  Up to approximately 35 weeks

Study Arms (1)

Camrelizumab+Chemotherapy

EXPERIMENTAL

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

Biological: Camrelizumab; Drug: Nab paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide

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.

Camrelizumab+Chemotherapy

Nab paclitaxel DRUG

125 mg/m² on day 1, 8 and 15 of Cycles 1-4 (QW 3/4); IV infusion.

Camrelizumab+Chemotherapy

Epirubicin DRUG

90 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.

Camrelizumab+Chemotherapy

Cyclophosphamide DRUG

600 mg/m² on day 1 of Cycles 5-8 (Q2W); 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:

• Newly diagnosed breast cancer
• Years, female;
• 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);
• Stage at presentation: T1c N1-2 or T2-4 N0-2;
• at least one measurable lesion according to RECIST 1.1;
• Adequate function of major organs meets the following requirements:
• Neutrophils ≥ 1.5×10\^9/L
• Platelets ≥ 100×10\^9/L
• Hemoglobin ≥ 90g/L
• lymphocyte≥0.5×10\^9/L
• Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
• ALT and AST ≤ 3 × ULN
• ALP≤ 2.5 × ULN
• BUN and Cr ≤ 1.5 × ULN

You may not qualify if:

• Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
• Inflammatory breast cancer
• patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
• 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.
• 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

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University Recruiting

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

camrelizumab; Taxes; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Doxorubicin; 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

Central Study Contacts

Jinming Yu, MD

CONTACT

+8613806406293; jn7984729@public.jn.sd.cn

Yongsheng Wang, MD

CONTACT

+8613505409989; wangysh2008@aliyun.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Shandong Cancer Hospital and Institute

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 21, 2020
• Study Start: May 20, 2020
• Primary Completion: July 30, 2021
• Study Completion: February 28, 2024
• Last Updated: December 21, 2020

Record last verified: 2020-12

Locations

CN (1)