Neoadjuvant Therapy, Triple-Negative Breast Cancer (TNBC)
Conditions
Brief summary
This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.
Interventions
DRUGpaclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab
paclitaxel polymeric micelles 230-300mg/m2, d1 carboplatin AUC=5, d1 iparomilimab and tuvonralimab 5mg/kg, d1 Every 3 weeks (Q3W) is a cycle, a total of 6 cycles.
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Triple-negative breast cancer * The diameter of the primary tumor must be greater than 2cm, and the clinical stage should be II-III * There is sufficient primary organ function * The ECOG (PS) score is 0 or 1 * Expected survival ≥ 6 months * The serum pregnancy test was negative. Use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed
Exclusion criteria
* Bilateral breast cancer * There is a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) * A history of invasive or metastatic breast cancer * Any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma * There is an immune deficiency disease * The presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint | After surgery（within 1 month） | Pathological complete response (pCR) rates in patients with triple-negative breast cancer |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | During neoadjuvant therapy before surgery（within 6 months） |
| The rate of event-free Survival (EFS) | 2-year |
| The incidence of treatment-related adverse event | 2-year |
Countries
China
Outcome results
None listed