Inflammatory Blood Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT05468710 | Unknown

• 1 other identifier: MD 134/2022
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Breast cancer is the most threatening disease in women. Neoadjuvant chemotherapy is a commonly used for the treatment. Inflammation plays an important role in tumor proliferation, metastasis, and resistance to chemotherapy. Inflammatory blood markers (IBM) reflect the balance between host inflammatory and immune status. Different IBM have been reported as prognostic factors for survival and predictive factors for pathological complete response and toxicity. Our aim to evaluate these IBM in breast cancer patients receiving neoadjuvant chemotherapy.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (6)

• Correlation between inflammatory blood marker (neutrophil to lymphocyte ration (NLR)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).

  * The neutrophil to lymphocyte ratio (NLR) was provided by the ratio between the absolute count of neutrophils and the absolute count of lymphocytes (NLR = N /L) * Pathological complete response (PCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system). * Toxicity endpoint, will be retrieved and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  1 year

• Correlation between inflammatory blood marker (Platelet to lymphocyte ratio(PLR)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).

  * The Platelet to lymphocyte ratio(PLR) was provided by the ratio between the absolute count of platelets and the absolute count of lymphocytes (PLR= P/L) * Pathological complete response (PCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system). * Toxicity endpoint, will be retrieved and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  1 year

• Correlation between inflammatory blood marker (monocyte to lymphocyte ratio(MLR)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).

  * The Monocyte to lymphocyte ratio (MLR) was provided by the ratio between the absolute count of monocytes and the absolute count of lymphocytes (MLR= M/L) * Pathological complete response (PCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system). * Toxicity endpoint, will be retrieved and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  1 year

• Correlation between inflammatory blood marker (systemic immune-inflammation index(SII)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).

  * The systemic immune-inflammation index is based on neutrophil (N), platelet (P) and lymphocyte (L) counts (SII = N × P/L) . * Pathological complete response (PCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system). * Toxicity endpoint, will be retrieved and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  1 year

• Correlation between inflammatory blood marker (systemic inflammation response index (SIRI)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).

  * systemic inflammation response index (SIRI) is based on neutrophils(N), monocytes(M) and lymphocytes(L) (SIRI=N×M/L) . * Pathological complete response (PCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system). * Toxicity endpoint, will be retrieved and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  1 year

• Correlation between inflammatory blood marker (Pan-Immune-Inflammation-Value (PIV)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).

  * Pan-Immune-Inflammation-Value (PIV) is based on neutrophils(N), monocytes(M),platelet(P) and lymphocytes(L) (PIV=N×M×P/L). * Pathological complete response (PCR) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (i.e., ypT0/Tis ypN0 in the current AJCC staging system). * Toxicity endpoint, will be retrieved and graded using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  1 year

Secondary Outcomes (6)

• Correlation between inflammatory blood marker (neutrophil to lymphocyte ration (NLR)) and disease-free survival (DFS) and overall survival (OS).

  1 year

• Correlation between inflammatory blood marker (Platelet to lymphocyte ratio(PLR)) and disease-free survival (DFS) and overall survival (OS).

  1 year

• Correlation between inflammatory blood marker ( Monocyte to lymphocyte ratio (MLR)) and disease-free survival (DFS) and overall survival (OS).

  1 year

• Correlation between inflammatory blood marker (Systemic immune-inflammation index (SII)) and disease-free survival (DFS) and overall survival (OS).

  1 year

• Correlation between inflammatory blood marker (systemic inflammation response index (SIRI)) and disease-free survival (DFS) and overall survival (OS).

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Invasive breast cancer, Above cT1 stage, all subtypes are included, who completed neoadjuvant systemic therapy.

You may qualify if:

• Patients aged 18 years old or more.
• Histologically proven invasive breast cancer.
• Above cT1 stage, any N Stage with no distant metastasis M0.
• All subtypes are included, either HR (ER, PR) positive or negative, HER2 positive or negative.
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
• Patients who completed their systemic neoadjuvant therapy.
• Available baseline complete blood picture before starting treatment.

You may not qualify if:

• Second malignancy.
• Patients with early breast cancer cT1 (≤ 2 cm) N0.
• Metastatic patients M1.
• Patients with systemic inflammatory diseases or autoimmune diseases (Type I Diabetes mellitus, Systemic Lupus Erytheromatosis, Rheumatoid Arthritis, Sjogren's syndrome, Behcet disease).
• Pregnancy-related breast cancer.
• Patients with chronic diseases (liver cirrhosis, or end-stage renal disease).
• Patients on systemic steroids as well as those under NSAIDS or other immunomodulators (as Methotraxate, Tacrolimus and Cyclosporine).
• Patient who received radiotherapy or endocrine or targeted therapy prior to neoadjuvant chemotherapy.
• Patients who started but didn't complete neoadjuvant systemic therapy.
• Patients who didn't undergo surgery after neoadjuvant systemic therapy.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (9)

• Sahin AB, Cubukcu E, Ocak B, Deligonul A, Oyucu Orhan S, Tolunay S, Gokgoz MS, Cetintas S, Yarbas G, Senol K, Goktug MR, Yanasma ZB, Hasanzade U, Evrensel T. Low pan-immune-inflammation-value predicts better chemotherapy response and survival in breast cancer patients treated with neoadjuvant chemotherapy. Sci Rep. 2021 Jul 19;11(1):14662. doi: 10.1038/s41598-021-94184-7.

  PMID: 34282214 BACKGROUND

• Chen L, Kong X, Wang Z, Wang X, Fang Y, Wang J. Pre-treatment systemic immune-inflammation index is a useful prognostic indicator in patients with breast cancer undergoing neoadjuvant chemotherapy. J Cell Mol Med. 2020 Mar;24(5):2993-3021. doi: 10.1111/jcmm.14934. Epub 2020 Jan 27.

  PMID: 31989747 BACKGROUND

• Corbeau I, Thezenas S, Maran-Gonzalez A, Colombo PE, Jacot W, Guiu S. Inflammatory Blood Markers as Prognostic and Predictive Factors in Early Breast Cancer Patients Receiving Neoadjuvant Chemotherapy. Cancers (Basel). 2020 Sep 18;12(9):2666. doi: 10.3390/cancers12092666.

  PMID: 32962003 BACKGROUND

• Dong J, Sun Q, Pan Y, Lu N, Han X, Zhou Q. Pretreatment systemic inflammation response index is predictive of pathological complete response in patients with breast cancer receiving neoadjuvant chemotherapy. BMC Cancer. 2021 Jun 14;21(1):700. doi: 10.1186/s12885-021-08458-4.

  PMID: 34126950 BACKGROUND

• Eren T, Karacin C, Ucar G, Ergun Y, Yazici O, Imamoglu GI, Ozdemir N. Correlation between peripheral blood inflammatory indicators and pathologic complete response to neoadjuvant chemotherapy in locally advanced breast cancer patients. Medicine (Baltimore). 2020 May 29;99(22):e20346. doi: 10.1097/MD.0000000000020346.

  PMID: 32481414 BACKGROUND

• Hu Y, Wang S, Ding N, Li N, Huang J, Xiao Z. Platelet/Lymphocyte Ratio Is Superior to Neutrophil/Lymphocyte Ratio as a Predictor of Chemotherapy Response and Disease-free Survival in Luminal B-like (HER2-) Breast Cancer. Clin Breast Cancer. 2020 Aug;20(4):e403-e409. doi: 10.1016/j.clbc.2020.01.008. Epub 2020 Jan 30.

  PMID: 32201163 BACKGROUND

• Jiang C, Lu Y, Zhang S, Huang Y. Systemic Immune-Inflammation Index Is Superior to Neutrophil to Lymphocyte Ratio in Prognostic Assessment of Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy. Biomed Res Int. 2020 Dec 18;2020:7961568. doi: 10.1155/2020/7961568. eCollection 2020.

  PMID: 33381583 BACKGROUND

• Ligorio F, Fuca G, Zattarin E, Lobefaro R, Zambelli L, Leporati R, Rea C, Mariani G, Bianchi GV, Capri G, de Braud F, Vernieri C. The Pan-Immune-Inflammation-Value Predicts the Survival of Patients with Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Breast Cancer Treated with First-Line Taxane-Trastuzumab-Pertuzumab. Cancers (Basel). 2021 Apr 19;13(8):1964. doi: 10.3390/cancers13081964.

  PMID: 33921727 BACKGROUND

• Peng Y, Chen R, Qu F, Ye Y, Fu Y, Tang Z, Wang Y, Zong B, Yu H, Luo F, Liu S. Low pretreatment lymphocyte/monocyte ratio is associated with the better efficacy of neoadjuvant chemotherapy in breast cancer patients. Cancer Biol Ther. 2020;21(2):189-196. doi: 10.1080/15384047.2019.1680057. Epub 2019 Nov 4.

  PMID: 31684807 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Nivine M Gado, phd

  Ain Shams University

  STUDY DIRECTOR

Central Study Contacts

Tawfik H Abdelmalak, MD

CONTACT

+201017031435; tawfikhelmy2009@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical oncology assistant lecturer, faculty of medicine

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 21, 2022
• Study Start: September 1, 2022
• Primary Completion: July 1, 2023
• Study Completion: December 1, 2023
• Last Updated: July 21, 2022

Record last verified: 2022-07