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PTC Guiding Neoadjuvant Treatment in Breast Cancer

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05103293
Collaborator
(none)
40
Enrollment
2
Arms
26
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: patient-derived tumor-like cell clusters drug sensitivity test
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Neoadjuvant Therapy for Breast Cancer Based on Patient-derived Tumor-like Cell Clusters Advanced Drug Sensitization Regimens: a Phase II Randomized Controlled Clinical Study
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. pCR rate [one month after operation]

      pathological complete response

    2. objective response rate [half year after randomize]

      cCR or PR or SD according to RECIST1.1

    Secondary Outcome Measures

    1. 2y-Disease free survival rate [2year]

      survive with neither invasive recurrence nor new invasive diseases

    2. 5y-Disease free survival rate [5year]

      survive with neither invasive recurrence nor new invasive diseases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Female between 18 to 70 years old.

    2. Patients diagnosed as invasive breast cancer by pathology.

    3. Clinical stage considered as T1-4N0-3M0.

    4. HER2 overexpression by IHC or FISH positive.

    5. Patients plan to accept neoadjuvant therapy, or plane 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 or not considered surgery therapy.

    3. Patients cannot accept chemotherapy or molecular targeted therapy, because of severe cardiovascular diseases or other reasons

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Zhejiang Cancer Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    YU Xingfei, Doctor, Zhejiang Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT05103293
    Other Study ID Numbers:
    • PTC-breastNAT
    First Posted:
    Nov 2, 2021
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by YU Xingfei, Doctor, Zhejiang Cancer Hospital
    patient-derived tumor-like cell clusters
    breast cancer
    neoadjuvant therapy
    pathologic complete response
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Nov 2, 2021