New treatments for early-stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II trial focuses on early-stage breast cancer (stage II-III) and evaluates the effectiveness of preoperative chemotherapy by comparing standard treatment with multiple experimental therapies. Utilizing an adaptive design, the trial allows for the addition of new treatments during or after the study, enhancing flexibility. Patients are categorized by subtype and randomized to receive either standard or experimental treatments, with the incorporation of circulating tumor DNA (ctDNA) analysis for better efficacy and prognosis predictions.

Why it matters

Who can join: the full rules

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 Criteria:

1. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.
2. History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.
3. Infection requiring systemic treatment.
4. 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).

Where it's running

• Nagoya City University
  Nagoya, Aichi-ken, Japan Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.