An observational study in Breast Cancer, sponsored by Guangdong Provincial People's Hospital. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-08-06.
Sponsored by Guangdong Provincial People's Hospital · Observational
The purpose of this clinical research is to evaluate the accuracy of a multi-parametric model based on magnetic resonance imaging (MRI) in predicting pathological complete response (pCR) after the first cycle of neoadjuvant therapy (NAT) given to patients with locally advanced breast cancer, thus allowing early chemotherapy regimen modification to increase number of patients achieving pCR or save patients from toxic effects of ineffective chemotherapy.
Breast cancer is the most prevalent cancer among women worldwide. NAT has been well established in managing breast cancer for patients with locally advanced cancer and early-stage operable breast cancers of specific molecular subtypes. Though pCR has been demonstrated to be associated with better survival, it can only be judged by pathological testing of surgically resected specimens. Thus, predicting pCR earlier during NAT is imperative and can timely switch to a new personalized treatment strategy and exempt from unnecessary chemotherapy toxicity for patients.
This is a multicenter, prospective cohort study of 301 patients undergoing MRI after the first cycle of neoadjuvant chemotherapy. This project plans to establish and validate a model for determining pCR during NAT in breast cancer based on clinical information, imaging and pathological information of patients in multiple centers, in order to provide important references for further early diagnosis and personalized treatment.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 301 is above the median of 184 across 2,711 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Guangdong Provincial People's Hospital is the lead sponsor of 237 studies on the registry; 102 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Selection of patients diagnosed with breast cancer and treated with neoadjuvant chemotherapy
For training cohort:
Inclusion Criteria:
Exclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
From January 2019 to December 2020, 140 patients from Guangdong Province People's Hospital with complete clinicopathological information and available images of MRI before treatment and after 1st-NAT were retrospectively recruited for the training cohort
From June 2021 and December 2023, 120 patients from Guangdong Province People's Hospital were prospectively recruited for the internal validation cohort.
From June 2021 and December 2023, 41 patients from Shantou Central Hospital, The First Affiliated Hospital of Guangdong Pharmaceutical University and The First People's Hospital of Foshan were prospectively recruited for the external validation cohort.
Sensitivity
Testing the sensitivity of NeoMDSS model to predict pCR using the area under receiver operating characteristic curve.
Time frame: up to 28 weeks
Specificity
Testing the sensitivity of NeoMDSS model to predict non-pCR using the area under receiver operating characteristic curve.
Time frame: up to 28 weeks
Specificity
Testing the difference in the tumor shrinkage patterns on magnetic resonance imaging (MRI) in triple-negative breast cancer patients receiving neoadjuvant therapy , as well as the correlation between tumor regression pattern and efficacy.
Time frame: up to 6 weeks
Shrinkage pattern
The difference in tumor regression shrinkage patterns between the different treatment groups. Based on the MRI after the first cycle, the tumor SPs were grouped into three categories: CS, diffuse decrease, and no change or enlargement.
Time frame: up to 28 weeks
correlation between shrinkage patterns and efficacy
The correlation between tumor regression shrinkage patterns and treatment efficacy.
Time frame: up to 28 weeks
Ran from Jan 2019 to primary completion in Jul 2023, 54 months.
Of 1,012 non-industry observational studies under Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 141. This study's 54 months is close to that.
Counting every sponsor, half of 1,165 studies reached it within 58 months; a quarter within 26 and three quarters within 125.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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