Clinical trial NCT04365790: Investigation of Gene Mutations in Patients With Triple-negative and Patients With HER2+ Breast Cancer Adenocarcinoma
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: Triple-negative breast cancer
HER2 positive breast adenocarcinoma
Lead sponsor: Hellenic Cooperative Oncology Group
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a retrospective analysis of patients with histologically confirmed HER2- positive breast adenocarcinoma,triple-negative breast cancer with high risk of recurrence.

Patients have been treated in Hellenic Cooperative Oncology Group (HeCOG)- affiliated departments of oncology.

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Αny 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: -

Primary outcomes:
measure: Progression free survival
timeFrame: From treatment initiation to the first documented disease progression, up to 5 years
measure: Overall survival
timeFrame: from thee date of treatment initiation until death from any cause or date of last contact whichever occurred first, assessed up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: George Fountzilas
Study officials:
affiliation: Hellenic Cooperative Oncology Group
name: George Foutzilas, MD
role: PRINCIPAL_INVESTIGATOR
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