Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06535893

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nagoya City University

Nagoya, Aichi-ken, 467-8601, Japan

Location status: Recruiting

Location contact

Kazuki Nozawa, MD

CONTACT

[email protected]

052-853-8628

Kazuki Nozawa, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically confirmed invasive breast carcinoma
  • Stage II or III
  • ECOG performance status of 0 or 1
  • Age 18-80

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).

Treatment and study plan

TN

Drug

Carboplatin + paclitaxel + pembrolizumab followed by doxorubicin + cyclophosphamide + pembrolizumab

TN-1

Drug

Carboplatin + paclitaxel + pembrolizumab followed by niraparib + pembrolizumab Niraparib Pembrolizumab AC

Other names: KEYNOTE-522 regimen

Primary outcomes

  1. 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.

  2. ctDNA clearance rate

    Time frame: Before Neoadjuvant chemotherapy to surgery

    ctDNA test was performed by Natera

Sponsors and collaborators

Lead sponsor

Nagoya City University

Other

Collaborators

  • Japan Clinical Oncology Group

Registry information

Official study title

Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)

Important dates

Study start
2024
Primary completion
2027
Study completion
2040
First posted
Aug 2, 2024
Registry last updated
Nov 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.