SBRT Combined With PD-1 Inhibitor and Chemotherapy in Early-stage TNBC
Recruiting
Phase 3
Interventional Study
TNBC - Triple-Negative Breast Cancer
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 318 (estimated)
- Sponsor
- West China Hospital · Other
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About This Trial
Triple-negative breast cancer (TNBC) presents significant challenges due to its limited treatment options and poor efficacy. While neoadjuvant chemotherapy has improved breast-conserving rates and extended survival for TNBC patients, this subtype still faces issues such as restricted treatment modalities, low pathological response rates, and unfavorable prognosis compared to other subtypes. Studie…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 1\. Histologically or cytologically confirmed TNBC (ER-, PR-, HER2-)
* 2\. cT1cN1-2M0 or cT2N0-2M0;(AJCC 7th)
* 3\. ECOG performance status of 0-1;
* 4\. Adequate bone marrow function, defined as: Hb ≥ 9.0 g/dL (90 g/L); ANC ≥ 1,500/mcL (1.5 × 10\^9/L); PLT ≥ 100,000/mcL (100 …
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