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Observation of improving the efficacy and prognosis of neoadjuvant chemotherapy for triple-negative breast cancer through early changes in effective chemotherapy regimens and combined PD-L1 inhibitors

Observation of improving the efficacy and prognosis of neoadjuvant chemotherapy for triple-negative breast cancer through early changes in effective chemotherapy regimens and combined PD-L1 inhibitors

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000029565
Enrollment
Unknown
Registered
2020-02-04
Start date
2019-08-01
Completion date
Unknown
Last updated
2020-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

Group 2:Change chemotherapy regimen, PDL1 treatment
Group 1:MRI assessment after three cycles of TCE protocol

Sponsors

Shenzhen Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. The result of cytological puncture through hollow core needle examination is invasive breast cancer; patients with primary invasive breast cancer are considered by comprehensively inquiring medical history, physical examination and B-ultrasound; all patients have at least one Measurable mass; proven non-distant metastatic breast cancer patients. (AJCC 7th edition staging criteria); 2. Never experienced breast cancer treatment, including medication and surgery, before going to the clinic; 3. The ECOG physical fitness score is assessed by a relevant experienced physician before treatment of the patient on a scale of 0 to 2; 4. The routine blood test before treatment should meet the following conditions: white blood cell count (WBC) >=4.0x10^9/L, neutrophil count (ANC) >=1.5x10^9/L, and platelet count (PLT) >=100x10^9/L; hemoglobin (Hb) >=90g/L; AST (sGOT), ALT (sGPT) <=1.5 ULN, creatinine <=1.5 ULN, total bilirubin <=1.5 ULN; 5. No serious damage to heart, liver and kidney function; 6. Sign the informed consent; 7. The initial treatment group was selected as the initial neoadjuvant three-week TAC regimen (T: docetaxel 75mg/m2 or paclitaxel 135mg/m2, iv, d1; A: pirarubicin 40mg/m2 or epirubicin 75mg/m2, iv, d1; C: cyclophosphamide 800mg/m2, iv, d1); 8. The change group of the selected plan was not satisfactory in the initial efficacy evaluation. Those who chose the second-line plan and adopted the TP plan (T: Docetaxel 75mg/m2 or Paclitaxel 135mg/m2, D1; P: Cisplatin 25mg/m2, d1, d2, D3); 9. Those who are not sensitive to the TP scheme are selected into the combined use PD-L1 group; 10. The refractory group is the one whose efficacy evaluation is not satisfactory after changing the protocol.

Exclusion criteria

Exclusion criteria: 1. Refused or unable to use acceptable methods of contraception during neoadjuvant chemotherapy for breast cancer; 2. Women who breastfeed during and after pregnancy; 3. Females with distant metastases from breast cancer and proven; 4. Patients with sensory or motor neuropathy and confirmed by relevant departments; 5. People with severe cardiovascular disease, cardiopulmonary insufficiency, active infection and HIV infection. 6. History of other malignant tumors; 7. Those who are allergic to therapeutic drugs or their accessories; 8. Withdrawal halfway.

Design outcomes

Primary

MeasureTime frame
Vital signs;blood routine;blood biochemical;B ultrasonography of breast and axillary lymph nodes;ECG;chest X-ray;

Countries

China

Contacts

Public ContactHong-Guang Liu
lhguang2006@126.com+86 18674752925

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026