Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)
Overview
- Phase
- Phase 2
- Intervention
- TN
- Conditions
- Breast Cancer
- Sponsor
- Nagoya City University
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- ctDNA clearance rate
- Status
- Recruiting
- Last Updated
- 5 months ago
Overview
Brief 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.
Detailed 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.
Investigators
Kazuki Nozawa
Principal Investigator
Nagoya City University
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically confirmed invasive breast carcinoma
- •Stage II or III
- •ECOG performance status of 0 or 1
Exclusion Criteria
- •Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.
- •History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.
- •Infection requiring systemic treatment.
- •Active double cancer (however, the following are not excluded: (1) Completely resected 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) Other cancers that have not recurred for more than 5 years).
Arms & Interventions
JCOG2205-TN
KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
Intervention: TN
JCOG2205-TN-1
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab
Intervention: TN-1
Outcomes
Primary Outcomes
ctDNA clearance rate
Time Frame: Before Neoadjuvant chemotherapy to surgery
ctDNA test was performed by Natera
pathological complete response (pCR)
Time Frame: Baseline to surgery
pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes.