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

ConditionBreast Cancer

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-80

SponsorNagoya City University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed invasive breast carcinoma

Stage II or III

ECOG performance status of 0 or 1

Age 18-80

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

TN
Drug
Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
TN-1
Drug
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: JCOG2205-TNActive comparator 1 intervention

Group B: JCOG2205-TN-1Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

pathological complete response (pCR)

pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes.

Time frame

Baseline to surgery

ctDNA clearance rate

ctDNA test was performed by Natera

Time frame

Before Neoadjuvant chemotherapy to surgery

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nagoya City University

Lead sponsor

Japan Clinical Oncology Group

Collaborator

Source ClinicalTrials.gov

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