PTC Guiding Neoadjuvant Treatment in Breast Cancer

NCT05103293 | Completed Phase 2

• 1 other identifier: PTC-breastNAT
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the primary endpoint.

Conditions

Pathological Conditions, Signs and Symptoms

Keywords

patient-derived tumor-like cell clusters; breast cancer; neoadjuvant therapy; pathologic complete response

Outcome Measures

Primary Outcomes (2)

• pCR rate

  pathological complete response

  one month after operation

• objective response rate

  cCR or PR or SD according to RECIST1.1

  half year after randomize

Secondary Outcomes (2)

• 2y-Disease free survival rate

  2year

• 5y-Disease free survival rate

  5year

Study Arms (2)

PTC group

EXPERIMENTAL

Patients randomized into this group receiving PTC test and choose regimens according to this test results

Diagnostic Test: patient-derived tumor-like cell clusters drug sensitivity test

Control group

NO INTERVENTION

Patients randomized into this group receiving routine regimens according to subtypes

Interventions

patient-derived tumor-like cell clusters drug sensitivity test DIAGNOSTIC_TEST

Intervention Description：Neoadjuvant therapy regimen of patients in the PTC group is guided by PTC drug sensitivity results. After operation, adjuvant targeted therapy for pCR patients is based on original treatment, adjuvant targeted therapy for non-pCR patients is based on a secondary PTC drug sensitivity results.

Also known as: PTC

PTC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female between 18 to 70 years old.
• Patients diagnosed with invasive breast cancer by pathology.
• Clinical stage considered as T2-4N0-2M0 .
• HER2 overexpression by IHC or FISH positive.
• Patients plan to accept neoadjuvant therapy or plan to accept adjuvant therapy after neoadjuvant therapy and surgery.

You may not qualify if:

• Patients have already accepted any other anti-tumor treatment not included in our project.
• Patients with metastasis are not considered surgery therapy.
• Patients cannot accept chemotherapy or anti-HER2 targeted therapy, because of severe cardiovascular diseases or other reasons

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

MeSH Terms

Conditions

Pathological Conditions, Signs and Symptoms; Breast Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes

Study Officials

• Xingfei Yu, M.D.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: November 2, 2021
• Study Start: November 1, 2021
• Primary Completion: December 10, 2023
• Study Completion: December 10, 2023
• Last Updated: December 27, 2023

Record last verified: 2023-12

Locations

CN (1)