Construction and Validation of an Assessment Model of PCR After NAT on Breast Cancer Patients With AI Technology

NCT05441098 | Unknown

• 1 other identifier: NCC3299
• Study Type: observational
• Target: 1,821
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is a major cause of survival for women worldwide. Neoadjuvant therapy as an important treatment for locally advanced breast cancer has had many positive effects for breast cancer patients. As drug therapy for breast cancer continues to evolve, the percentage of pathologic complete responses continues to increase. However, at present, pCR can only be judged by pathological testing of surgically resected specimens, and the question of whether pCR can be accurately judged preoperatively has become an urgent issue.Therefore, this project plans to establish and validate a model for determining pCR after NAT in breast cancer based on clinical information, imaging and pathological information of breast cancer patients in multiple centers using artificial intelligence technology in accordance with international guidelines and domestic expert consensus on breast cancer NAT, in order to solve the problem of surgical decision making for patients after NAT, by combining experts from breast medicine, surgery, pathology and imaging departments in several tertiary care hospitals across China. The model will be validated to solve the problem of surgical decision making for post-NAT patients.

Conditions

Breast Cancer

Keywords

Breast cancer; Neoaduvant therapy; Radiomics; Pathologic complete response

Outcome Measures

Primary Outcomes (1)

• pathological complete response

  Complete disappearance of breast cancer lesions from the pathology after chemotherapy

  Post surgery based on up to approximately 24 weeks neoadjuvant therapy

Study Arms (1)

Neoadjuvant therapy

Patients with breast cancer treated with neoadjuvant therapy attending each center from 2010-2020.

Other: Neoadjuvant therapy

Interventions

Neoadjuvant therapy OTHER

Preoperative systemic therapy for breast cancer patients

Neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer treated with neoadjuvant therapy and with MRI data attending each center from 2010-2020.

You may qualify if:

• patients admitted to each study center between January 1, 2010 and December 31, 2021.
• ≥18 years of age, female, with an ECOG score ≤2.
• pathological biopsy confirmed invasive breast cancer.
• were initially treated with neoadjuvant therapy.
• have MRI imaging data prior to radical surgery after neoadjuvant treatment.
• underwent surgery as planned after neoadjuvant therapy and obtained postoperative pathology information.

You may not qualify if:

• Bilateral breast cancer, multiple lesions or occult breast cancer.
• no data related to breast MRI.
• no surgery after neoadjuvant therapy, no postoperative pathology results.

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Peng Yuan, M.D.

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Yue, M.D.

CONTACT

+86 18612621749; sunlight_1985@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: April 1, 2022
• Primary Completion: June 1, 2022
• Study Completion: December 31, 2022
• Last Updated: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)