Clinical trial · Observational

Inflammatory Blood Markers in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

The Prognostic and Predictive Role of Inflammatory Blood Markers in Early and Locally Advanced Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

NCT05468710CI-TRIAL-00059794unknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (6)

measure
Correlation between inflammatory blood marker (neutrophil to lymphocyte ration (NLR)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).
timeFrame
1 year
description
* 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.
measure
Correlation between inflammatory blood marker (Platelet to lymphocyte ratio(PLR)) and rate of pathological complete response (PCR), and neutropenia / peripheral neuropathy (CTCAE grade).
timeFrame
1 year
description
* 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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

References

Publications (9)

BACKGROUNDSahin 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
BACKGROUNDChen 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
BACKGROUNDCorbeau 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
BACKGROUNDDong 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
BACKGROUNDEren 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
BACKGROUNDHu 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.