Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma

Triple Negative Breast Cancer Clinical Trial

Official title:

Carbonic Anhydrase IX Enzyme in Triple Negative Breast Carcinoma: Relationship With Prognostic Factors and Response to Neoadjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06309459
• Other study ID #: IRB 2023/04-34
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2024
• Source: Kahramanmaras Sutcu Imam University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Triple-negative breast carcinoma is characterized by the absence of estrogen receptors, progesterone receptors, and HER2/neu receptors. Carbonic anhydrase IX (CA IX) is a tumor-associated cell surface glycoprotein that is involved in adaptation to hypoxia-induced acidosis and plays a role in cancer progression. This study aimed to investigate CA IX expression in TNBC and its relationship with treatment effect.

Description:

Tru-cut biopsy materials, sent to our hospital pathology laboratory between August 2018 and May 2023, will be examined. Invasive carcinoma cases will be evaluated according to estrogen, progesterone, and HER 2 receptor levels. Triple-negative tumor cases were isolated and those cases who underwent breast resection in our hospital after receiving neoadjuvant chemotherapy (Adriamycin, cyclophosphamide, and then paclitaxel for 4 cycles) were included in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Older than 18 years
• Triple-negative mastectomy cases
• Patients whose data can be available
• Patients who were operated in our hospital

Exclusion Criteria:

• Younger than 18 years
• Not triple negative mastectomy cases
• Patients with missing data
• Patients who were operated in another hospital

Related Conditions & MeSH terms

• Breast Neoplasms
• Carcinoma
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Diagnostic Test:
• Carbonic anhydrase staining levels
CA IX is a transmembrane protein, it exhibits cytoplasmic membrane staining. Immunohistochemically positive cells were graded as Low staining if they constituted <10% of the total and high staining if they constituted = 10% (15).

Locations

Country	Name	City	State
Turkey	Kahramanmaras Sütçü Imam University	Kahramanmaras

Sponsors (1)

Lead Sponsor	Collaborator
Kahramanmaras Sutcu Imam University

Country where clinical trial is conducted

Turkey, 

References & Publications (9)

Bakherad H, Ghasemi F, Hosseindokht M, Zare H. Nanobodies; new molecular instruments with special specifications for targeting, diagnosis and treatment of triple-negative breast cancer. Cancer Cell Int. 2022 Aug 6;22(1):245. doi: 10.1186/s12935-022-02665-0. — View Citation

Carroll CP, Bolland H, Vancauwenberghe E, Collier P, Ritchie AA, Clarke PA, Grabowska AM, Harris AL, McIntyre A. Targeting hypoxia regulated sodium driven bicarbonate transporters reduces triple negative breast cancer metastasis. Neoplasia. 2022 Mar;25:41-52. doi: 10.1016/j.neo.2022.01.003. Epub 2022 Feb 9. — View Citation

Gillies RJ, Brown JS, Anderson ARA, Gatenby RA. Eco-evolutionary causes and consequences of temporal changes in intratumoural blood flow. Nat Rev Cancer. 2018 Sep;18(9):576-585. doi: 10.1038/s41568-018-0030-7. — View Citation

Godet I, Doctorman S, Wu F, Gilkes DM. Detection of Hypoxia in Cancer Models: Significance, Challenges, and Advances. Cells. 2022 Feb 16;11(4):686. doi: 10.3390/cells11040686. — View Citation

Lee P, Chandel NS, Simon MC. Cellular adaptation to hypoxia through hypoxia inducible factors and beyond. Nat Rev Mol Cell Biol. 2020 May;21(5):268-283. doi: 10.1038/s41580-020-0227-y. Epub 2020 Mar 6. — View Citation

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. — View Citation

Warburg O, Wind F, Negelein E. THE METABOLISM OF TUMORS IN THE BODY. J Gen Physiol. 1927 Mar 7;8(6):519-30. doi: 10.1085/jgp.8.6.519. No abstract available. — View Citation

Wu Q, You L, Nepovimova E, Heger Z, Wu W, Kuca K, Adam V. Hypoxia-inducible factors: master regulators of hypoxic tumor immune escape. J Hematol Oncol. 2022 Jun 3;15(1):77. doi: 10.1186/s13045-022-01292-6. — View Citation

Yin L, Duan JJ, Bian XW, Yu SC. Triple-negative breast cancer molecular subtyping and treatment progress. Breast Cancer Res. 2020 Jun 9;22(1):61. doi: 10.1186/s13058-020-01296-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Poor prognostic factors in patients with TNBC	Higher staining CA IX levels (= 10%) in TNBC patients' pathological specimens is a poor prognostic factor	2018-2023
Primary	The treatment success with inhibiting the CA IX enzyme levels' effectiveness	Treatment success in TNBC patients by evaluating changes in CA IX staining levels	2018-2023