HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
NCT03387553
Breast Cancer, Breast Cancer Female
Tampa, Florida, United States
View Trial DetailsNCT Number: NCT03800355
An observational, Other Designs (OD) post-marketing, multicenter study, which will obtain retrospective data from male patients diagnosed with invasive breast cancer between 2000 and 2019 in the medical oncology departments of hospitals that are associated with Spanish Breast Cancer Research Group (GEICAM) (using information obtained from patient medical histories).
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Notify Me18 year and older
Male
Observational
Complejo Hospitalario Universitario de Ferrol, Ferrol, A Coruña, Spain
One of the objectives of this project is to ensure representativeness of the cases referred to. Accordingly, participating sites agree to enroll in the study male patients who were diagnosed with breast cancer in the period between 2000 and 2019.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From date of patient breast cancer diagnosis until 2019.
General condition age will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
Performance status by Eastern Cooperative Oncology Group (ECOG) Scale
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With Substance abuse of tobacco and alcohol will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
Diagnosis of other primary tumors synchronous or metachronous, will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
BMI is a value derived from the mass (weight) and height. The BMI is defined as the body mass divided by the square of the body height, and is universally expressed in units of kg/m2, resulting from mass in kilograms and height in metres.
Time frame: From date of patient breast cancer diagnosis until 2019.
Primary comorbidities will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
Mutational status of BRCA or other genes of genetic predisposition will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
Family history of cancer will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
Date of diagnosis will be collected.
Time frame: From date of patient breast cancer diagnosis until 2019.
The histology of the tumor will be collected
Time frame: From date of patient breast cancer diagnosis until 2019.
Tumor clinical and/or pathological stage will be collected through the tumor-node-metastasis (TNM) staging system of the Union for International Cancer Control (UICC).
Time frame: From date of patient breast cancer diagnosis until 2019.
Hormone-receptor expression will be collected
Time frame: From date of patient breast cancer diagnosis until 2019.
Human Epidermal Growth Factor Receptor 2 (HER-2) expression will be collected
Time frame: From date of patient breast cancer diagnosis until 2019.
Tumor histologic grade will be collected
Time frame: From date of patient breast cancer diagnosis until 2019.
Tumor Ki-67 proliferation index will be collected
Time frame: From date of patient breast cancer diagnosis until 2017.
Number of Participants With Presence of lymphovascular invasion will be collected
Time frame: From date of patient breast cancer diagnosis until 2019.
Will be collected date of surgery
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of participants with each type of surgery: mastectomy or lumpectomy or quadrantectomy or lymphadenectomy or sentinel lymph node biopsy will be collected.
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With neoadjuvant chemotherapy and adjuvant chemotherapy.
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With adjuvant radiotherapy
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With hormonotherapy
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With other type of anti-cancer treatment.
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With each relapse type: local, regional or distant
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With site of metastatic disease
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With occurrence of other primary tumors whether or not of breast origin (in situ or invasive).
Time frame: From date of patient breast cancer diagnosis until 2019.
The date of the last review and current clinical condition will be recorded.
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With tumor subtypes, luminal profiles (e.g., luminal subtypes M1/M2, intrinsic subtypes)
Time frame: From date of patient breast cancer diagnosis until 2019.
Number of Participants With risk groups on the reference of breast cancer in women, including morphological analyses and description of the clinical profile (e.g., morphological type, differentiation (histologic grade), Estrogen Receptor (ER), Progesterone Receptor (PgR), Human Epidermal growth factor Receptor 2 (HER2), Androgen Receptor (AR), Ki-67).
Time frame: From date of patient breast cancer diagnosis until 2019.
Date and cause of death, when applicable.
Time frame: From date of patient breast cancer diagnosis until 2019.
DFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented relapse event (local, regional and/or distant) of the disease, second breast or non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
Time frame: From date of patient breast cancer diagnosis until 2019.
DMFS: it is defined as the time from date of initial breast cancer diagnosis to the date of the first documented distant relapse, second invasive non-breast primary tumor, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
Time frame: From date of patient breast cancer diagnosis until 2019.
PFS: it is defined as the time from the start date of a specific treatment to the documentation of disease progression on such treatment, or death due to any cause, whichever occurs first. In the event that none of the previous events were observed, censoring the last contact date will be considered.
Time frame: From date of patient breast cancer diagnosis until 2019.
OS: it is defined as the time from the date of initial breast cancer diagnosis to the date of death due to any cause.
Spanish Breast Cancer Research Group
Other
An Observational, Retrospective Study on the Progress of Breast Cancer Cases in Males and the Assessment of Relapse Risk Through Gene Sequencing
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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