Clinical trial · Interventional
Apatinib in Neoadjuvant Therapy for Patients With Breast Cancer
Efficacy and Safety of Apatinib Added to Docetaxel and Cisplatin Neoadjuvant Therapy for Patients With Breast Cancer: a Randomized, Parallel Controlled Phase II Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To verify the role of apatinib in neoadjuvant therapy for breast cancer, the investigators designed a prospective, randomized, parallel-controlled phase II/III trial, to investigate the efficacy and safety of apatinib combined with TP (paclitaxel + cisplatin) or TP regimen alone as neoadjuvant therapy for stage II-III breast cancer treatment. 100 cases of eligible patients were diagnosed by core needle biopsy and immunohistochemistry, with the molecular subtypes of triple-negative, HER2+ or Luminal B, evaluated by pathological complete remission (pCR), objective response rate (ORR), adverse events, disease free survival (DFS) and OS, aiming at providing a new way for neoadjuvant therapy in breast cancer and anti-angiogenic treatment of malignant tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- apatinib+TP
- description
- TP neoadjuvant chemotherapy (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3) combined with apatinib (received TP concurrently with apatinib 500mg, day1-21).
- interventionNames
- Drug: Apatinib
- Drug: paclitaxel
- Drug: cisplatin
- type
- SHAM_COMPARATOR
- label
- TP
- description
- TP neoadjuvant chemotherapy alone (paclitaxel 165mg/m2 day 1, cisplatin 40mg, day 1-3).
- interventionNames
- Drug: paclitaxel
- Drug: cisplatin
Primary outcomes (1)
- measure
- The primary endpoint is pathological complete remission (pCR)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. breast invasive carcinoma diagnosed by core needle biopsy, without previous treatments for breast cancer; 2. with the molecular subtypes of triple-negative, HER2+ or Luminal B, confirmed by immunohistochemistry; 3. breast cancer within stage IIb-IIIc, planned to receive neoadjuvant therapy; 4. women aged from 18 to 70 years old; 5. required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; 6. left ventricular ejection fraction (LVEF) greater than 55% without clinical symptoms or signs of heart failure; 7. Adequate bone marrow, with white blood cell ≥4.0×109 /L,neutrophils ≥2.0×109 /L, platelet ≥100×109 /L, hemoglobin ≥ 90 g/L; 8. Serum creatinine ranges from 44 to 133 mol/L; 9. Glutamic pyruvic transaminase and Glutamic-oxalacetic Transaminase ≤2 times to superior limit of normal value; 10. bilirubin ≤ superior limit of normal value; 11. Expected survival ≥ 12 months; 12. pregnancy tests must be negative, and the couples of patients should agree to use effective contraception during treatment and the following one year; 13. approved by the institutional ethnics committee of the Fourth Hospital of Hebei Medical University, with signature to the Informed consent. Exclusion Criteria: 1. severe systemic infection; 2. being allergic or intolerant to apatinib, paclitaxel, cisplatin; 3. having received any testing drugs, radiotherapy or other chemotherapy drugs within 30 days before being enrolled in this trial; 4. uncontrolled hypertension, severe heart function; 5. researchers believe that participating in the test does not meet the best interests of the patients (e.g. cause adverse health) or may interfere with the evaluation of response.
References
Publications (0)
Data not yet available