Breast CancerPhase 2NCT06535893
Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer
A Phase 2 study testing TN and TN-1 in people with Breast Cancer, run by Nagoya City University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- TN and TN-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteJapan
- Study dates
- 30 Jul 2024to 30 Jun 2040
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed invasive breast carcinoma
- Stage II or III
- ECOG performance status of 0 or 1
- Age 18-80
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Japan1 site, 1 recruiting
- Recruiting
Nagoya City University
Nagoya, Aichi-ken, 467-8601
Kazuki Nozawa, MD, 052-853-8628, k.nozawa@med.nagoya-cu.ac.jp
Kazuki Nozawa, MD
About this study
Official title: Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)
Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- TN, TN-1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNDrug
Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab
TN-1Drug
Also called KEYNOTE-522 regimen
Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC
| Study group | Role | What they receive |
|---|---|---|
| JCOG2205-TN | Active comparator | KEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab Receives: Drug: TN |
| JCOG2205-TN-1 | Experimental | Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Receives: Drug: TN-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response (pCR)
pCR is defined as the absence of invasive cancer in the breast and sampled regional lymph nodes.
Measured: Baseline to surgery
ctDNA clearance rate
ctDNA test was performed by Natera
Measured: Before Neoadjuvant chemotherapy to surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2024
- Study start30 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Responsible party
- Principal investigator, Kazuki Nozawa, Nagoya City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06535893
- Sponsor's protocol ID
- JCOG2205
- Status last verified
- Nov 2025
- First submitted
- 30 Jul 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)
- ClinicalTrials.gov ID
- NCT06535893
- Acronym / sponsor ID
- JCOG2205
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Collaborators
- Japan Clinical Oncology Group
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2040 (estimated)
- First posted
- 2 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JCOG2205-TN | Active comparator | Drug: TNKEYNOTE-522 regimen: Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab |
| JCOG2205-TN-1 | Experimental | Drug: TN-1Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically or cytologically confirmed invasive breast carcinoma
- Stage II or III
- ECOG performance status of 0 or 1
- Age 18-80
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNCarboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab | Drug | JCOG2205-TN |
| TN-1Also: KEYNOTE-522 regimenCarboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC | Drug | JCOG2205-TN-1 |
Primary outcome
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.
ctDNA clearance rate
Time frame: Before Neoadjuvant chemotherapy to surgery
ctDNA test was performed by Natera
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TN and TN-1 in people with Breast Cancer, run by Nagoya City University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathological complete response (pCR) (time frame: Baseline to surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.