Clinical trial NCT04264468: Correlation Between Molecular Typing and Neoadjuvant Chemotherapy in Breast Cancer Patients Based on Mammaprint/Blueprint Test
Official title: Correlation Between Molecular Typing and Neoadjuvant Chemotherapy in Breast Cancer Patients Based on Mammaprint/Blueprint Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Evaluation of the Value of Mammaprint Test Gene Variation in the Prediction of Neoadjuvant Chemotherapy for Breast Cancer
Keywords: neoadjuvant chemotherapy
Mammaprint
blueprint
prognosis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2020-02-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * Pathologically confirmed new breast cancer (invasive cancer)
* Clinical stage II-III
* women
* Aged 25-80

Brief summary: This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the technical analysis of Mammaprint in patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in tumor tissues and evaluated the accuracy and sensitivity of Mammaprint test in the efficacy of neoadjuvant chemotherapy.A new model for predicting NCT effect of breast cancer with combined risk genes and clinical parameters was established based on the clinical characteristic parameters of patients to study the accuracy and sensitivity of Mammaprint monitoring for prognosis determination of breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed new breast cancer (invasive cancer)
* Clinical stage II-III
* women
* Aged 25-80
* At least 6 months of follow-up data, clinical diagnosis and treatment information and personal information available for follow-up are complete
* Complete biological samples required for the study: fresh/frozen tissues/white tablets/wax blocks meeting the requirements of the experiment (before neoadjuvant chemotherapy)
* Tumor markers and imaging data were complete
* Neoadjuvant chemotherapy is commonly recommended by the standard NCCN guidelines

Exclusion Criteria:

* Subjects refuse to participate
* First diagnosis of stage I or IV breast cancer
* Pathological diagnosis of concurrent (or previous) other malignant tumors
* Prehistory breast cancer
* Younger than 25 or older than 80
* Clinical diagnosis and treatment information or biological samples required by the research institute do not meet the needs of the experiment

Primary outcomes:
measure: Recurrence Score variation after neoadjuvant chemotherapy
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: