Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer

Last updated: November 12, 2024
Sponsor: Nagoya City University
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

TN

TN-1

Clinical Study ID

NCT06535893
JCOG2205
  • Ages 18-80
  • All Genders

Study Summary

Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically or cytologically confirmed invasive breast carcinoma

  2. Stage II or III

  3. ECOG performance status of 0 or 1

  4. Age 18-80

Exclusion

Exclusion Criteria:

  1. Continuous systemic administration (oral or intravenous) of steroid drugs or otherimmunosuppressants.

  2. History or complication of interstitial lung disease or pulmonary fibrosis diagnosedby imaging or clinical findings.

  3. Infection requiring systemic treatment.

  4. Active double cancer (however, the following are not excluded: (1) Completelyresected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage I,carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2)Gastrointestinal cancer that has been curatively resected by ESD or EMR, (3) Othercancers that have not recurred for more than 5 years).

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: TN
Phase: 2
Study Start date:
June 24, 2024
Estimated Completion Date:
June 30, 2040

Study Description

This randomized phase II trial targets early-stage breast cancer (stage II-III) with preoperative chemotherapy (NAC). It compares standard treatment with multiple experimental treatments using an adaptive design, allowing new treatments to be added during or after the trial. Patients are classified by subtype and randomized between standard and experimental treatments.

The trial is flexible, permitting single or combination new drug therapies and incorporating circulating tumor DNA (ctDNA) evaluation for precise efficacy and prognosis prediction.

Connect with a study center

  • Nagoya City University

    Nagoya, Aichi 467-8601
    Japan

    Active - Recruiting

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