Investigation of Gene Mutations in Patients With Triple-negative and Patients With HER2+ Breast Cancer Adenocarcinoma

Breast Cancer Clinical Trial

Official title:

Investigation of Gene Mutations or Changes in Protein Expression,as Biomarkers With Prognostic/Predictive Value, in Patients With Triple-negative and in Patients With HER2+ Breast Cancer Adenocarcinoma,Who Underwent Intensive Adjuvant Chemotherapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04365790
• Other study ID #: HE10/13
• Status: Active, not recruiting
• Start date: April 18, 2013
• Est. completion date: September 2023

Study information

• Verified date: March 2023
• Source: Hellenic Cooperative Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The present study is a transnational study in patients with high risk recurrent breast cancer who receive adjuvant chemotherapy with epirubicin and cyclophosphamide followed by docetaxel or paclitaxel.

Description:

This will be a retrospective analysis of patients with histologically confirmed triple-negative or HER2+ operable breast cancer (with high risk of recurrence) who are treated at Hellenic Cooperative Oncology Group (HeCOG)- affiliated departments of oncology. Patients who participate are 18 years or older, women of any menopausal status with triple-negative or HER2+ breast cancer who receive epirubicin and cyclophosphamide every two weeks followed by docetaxel every three weeks or weekly paclitaxel. Patients with HER2-positive tumors are treated with trastuzumab, initiated concurrently with the first cycle of docetaxel, for 52 weeks. Pertuzumab may be combined with trastuzumab only in patients with node-positive disease.Patients can be treated with hormone therapy and/or radiotherapy. The investigation of the potential biomarkers will be performed using in situ methods in Formalin fixed paraffin embedded (FFPE) tumor sections. More specific will be investigated the expression of estrogen and progesterone receptors, the expression of SPARC proteins, special cellular activation and metastasis systems and other important pathways in cell life and reproduction. Statistical analysis: The primary endpoint of the study will be the progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Second primary endpoint will be the overall survival (OS), defined as the time from treatment initiation to patient's death or last contact. Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: September 2023
• Est. primary completion date: December 21, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years or older
• ?ny menopausal status is allowed
• triple-negative breast cancer
• HER2+ breast adenocarcinoma
• tumor size <= 5 cm
• presence of operable axillary lymph nodes or the presence of clinicopathological parameters indicating an intermediate or high risk of recurrence without the presence of infiltrated lymph nodes
• Performance status (PS) = 0 or 1
• adequate bone marrow function , heart, liver and kidney
• no other history of previous neoplasm or other serious illness Exclusion Criteria: -

Related Conditions & MeSH terms

• Adenocarcinoma
• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Greece	George Fountzilas	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

References & Publications (7)

Camp RL, Charette LA, Rimm DL. Validation of tissue microarray technology in breast carcinoma. Lab Invest. 2000 Dec;80(12):1943-9. doi: 10.1038/labinvest.3780204. — View Citation

Fisher B, Bauer M, Wickerham DL, Redmond CK, Fisher ER, Cruz AB, Foster R, Gardner B, Lerner H, Margolese R, et al. Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer. 1983 Nov 1;52(9):1551-7. doi: 10.1002/1097-0142(19831101)52:93.0.co;2-3. — View Citation

Kononen J, Bubendorf L, Kallioniemi A, Barlund M, Schraml P, Leighton S, Torhorst J, Mihatsch MJ, Sauter G, Kallioniemi OP. Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat Med. 1998 Jul;4(7):844-7. doi: 10.1038/nm0798-844. — View Citation

Meyer JS, McDivitt RW, Stone KR, Prey MU, Bauer WC. Practical breast carcinoma cell kinetics: review and update. Breast Cancer Res Treat. 1984;4(2):79-88. doi: 10.1007/BF01806389. — View Citation

Nissen-Meyer R, Kjellgren K, Mansson B. Adjuvant chemotherapy in breast cancer. Recent Results Cancer Res. 1982;80:142-8. doi: 10.1007/978-3-642-81685-7_24. — View Citation

Norton L. Theoretical concepts and the emerging role of taxanes in adjuvant therapy. Oncologist. 2001;6 Suppl 3:30-5. doi: 10.1634/theoncologist.6-suppl_3-30. — View Citation

Skacel M, Skilton B, Pettay JD, Tubbs RR. Tissue microarrays: a powerful tool for high-throughput analysis of clinical specimens: a review of the method with validation data. Appl Immunohistochem Mol Morphol. 2002 Mar;10(1):1-6. doi: 10.1097/00129039-200203000-00001. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		From treatment initiation to the first documented disease progression, up to 5 years
Primary	Overall survival		from thee date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years