PTC Guiding Neoadjuvant Treatment in Breast Cancer

Neoadjuvant Therapy for Breast Cancer Based on Patient-derived Tumor-like Cell Clusters Advanced Drug Sensitization Regimens: a Phase II Randomized Controlled Clinical Study

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.

Study Overview

• Status: Completed
• Conditions: Pathological Conditions, Signs and Symptoms
• Intervention / Treatment: Diagnostic test: patient-derived tumor-like cell clusters drug sensitivity test

Detailed Description

1. Before neoadjuvant therapy, all samples will be obtained by core needle biopsy for PTC drug sensitivity test.
2. After obtaining drug sensitivity results and confirming ER/PR and HER2 expression state, all recruited patients will be randomized into the PTC group or the routine treatment group, according to the method of random number table.
3. Beijing Cornerstone Life Science and Technology Co., Ltd. is responsible for gene sequencing and PTC drug sensitivity test for biological samples. All samples for the study are clinical residuals and will be used in the study, store or destruction is unapplicable.
4. Neoadjuvant therapy regimen in the PTC group is guided by PTC drug sensitivity results, and regimen in the routine treatment group is based on clinical guideline, such as (dd)EC-T for HER2 negative breast cancer, and TCH(P) or EC-TH(P) for HER2 positive breast cancer. All neoadjuvant therapy will be completed before operation if without PD.
5. According to postoperative pathological remission, pCR patients in two groups continued to complete adjuvant targeted therapy based on original treatment. For non-pCR patients in the PTC group, PTC drug sensitivity test will be done again to guide adjuvant therapy, for non-pCR patients in the routine treatment group, Capecitabine for HER2 negative breast cancer, and T-DM1 or H(P) will be selected.
6. All patients will be received radiotherapy or endocrine therapy if necessary.

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTC group; 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; 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.; Other Names: PTC
No Intervention: Control group; Patients randomized into this group receiving routine regimens according to subtypes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
2y-Disease free survival rate	survive with neither invasive recurrence nor new invasive diseases	2year
5y-Disease free survival rate	survive with neither invasive recurrence nor new invasive diseases	5year

Collaborators and Investigators

• Sponsor: Zhejiang Cancer Hospital
• Investigators: Principal Investigator: Xingfei Yu, M.D., Zhejiang Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): December 10, 2023
• Study Completion (Actual): December 10, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 29, 2021
• First Posted (Actual): November 2, 2021

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; neoadjuvant therapy; patient-derived tumor-like cell clusters; pathologic complete response
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PTC-breastNAT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No