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Application of Anlotinib Hydrochloride Capsules in Neoadjuvant Chemotherapy for Triple Negative Breast Cancer

Application of Anlotinib Hydrochloride Capsules in Neoadjuvant Chemotherapy for Triple Negative Breast Cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038174
Enrollment
Unknown
Registered
2020-09-12
Start date
2019-01-16
Completion date
Unknown
Last updated
2020-11-30

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

Conditions

Triple negative breast cancer

Interventions

experimental group :Anlotinib hydrochloride + Neoadjuvant chemotherapy

Sponsors

The Second Affiliated Hospital of Xi'an Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Patients voluntarily participate in this study; 2. Patients with locally advanced triple-negative breast cancer (stage IIB, IIIA, IIIB, and IIIC) diagnosed by pathology; 3. Have not received any anti-tumor treatment (including any form of chemotherapy, radiotherapy, and Chinese medicine treatment) within at least one month before treatment; 4. Hemoglobin (HB) >= 90g/L; 5. The absolute value of neutrophils (ANC) >=1.5x10^9/L; 6. Platelets (PLT) >=80x10^9/L; 7. Total bilirubin (TBIL) = 60ml/min.

Exclusion criteria

Exclusion criteria: 1. Received radiotherapy, chemotherapy and targeted therapy within at least one month before enrollment; 2. Concomitant with other malignant diseases or diagnosed with other malignant diseases within 5 years before enrollment; 3. Patients who have used Anlotinib Hydrochloride Capsules in the past; 4. Patients with any severe or uncontrolled disease; 5. There are many factors that affect oral drugs (such as: inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 6. Participated in other anti-tumor drug clinical trials within four weeks; 7. Arterial/venous thrombosis occurred within 6 months; 8. According to the investigator's judgment, the tumor is very likely to invade important blood vessels and cause fatal bleeding during the follow-up trial; 9. According to the judgment of the investigator, there is a concomitant disease that seriously endangers the safety of the patient or affects the completion of the trial.

Design outcomes

Primary

MeasureTime frame
Pathological complete remission;

Secondary

MeasureTime frame
Progression-free survival;Objective response rate;safety;

Countries

China

Contacts

Public ContactShuqun Zhang
zhangshuqun1971@aliyun.com+86 13891841249

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026