Related Experiment Video
Updated: May 11, 2026
Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Neoadjuvant rh-endostatin, docetaxel and epirubicin for breast cancer: efficacy and safety in a prospective,
Background:
Recombinant human endostatin (rh-endostatin) is a novel antiangiogenesis drug developed in China. Previous experiments have shown that rh-endostatin can inhibit the proliferation and migration of endothelial cells and some types of tumor cells. In this study, we evaluated the efficacy and safety profiles of combination therapy of rh-endostatin and neoadjuvant chemotherapy for breast cancer patients in a prospective, randomized, controlled, phase II trial.
Methods:
Sixty-eight patients with core-biopsy confirmed breast cancer were allocated randomly to two groups to receive 3 cycles of intravenous administration of either neoadjuvant DE (docetaxel: 75 mg/m2, d1, epirubicin: 75 mg/m2, d1, every 3 weeks), or neoadjuvant DE combined with rh-endostatin (7.5 mg/m2, d1-d14, every 3 weeks). The primary end point was clinical response based upon Response Evaluation Criteria in Solid Tumors, and the secondary end point was safety and quality of life.
Results:
All patients were assessable for toxicity and 64 (94.2%) were assessable for efficacy evaluation. The objective response rate was 67.7% for chemotherapy (n = 31) and 90.9% for rh-endostatin plus chemotherapy (n = 33) (P = 0.021). A retrospective subset analysis revealed that rh-endostatin was more effective in premenopausal patients and patients with ECOG score of zero (P = 0.002 and P = 0.049, respectively). Five patients in the rh-endostatin plus chemotherapy arm achieved pathologic complete response compared with 2 in the chemotherapy arm (P = 0.428). No significant difference was identified in quality of life score and side effects (P > 0.05).
Conclusion:
The combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients.
Trial Registration:
ClinicalTrials.gov Identifier, NCT00604435.
Insights
Adding recombinant human endostatin (rh-endostatin) to neoadjuvant chemotherapy significantly improved tumor response rates in breast cancer patients. This combination therapy demonstrated enhanced efficacy without increasing adverse events or negatively impacting quality of life.
Area of Science:
- Oncology
- Pharmacology
- Clinical Trials
Background:
- Recombinant human endostatin (rh-endostatin) is a novel anti-angiogenesis agent.
- Previous studies indicated rh-endostatin inhibits endothelial cell and tumor cell proliferation and migration.
- This study evaluates rh-endostatin in combination with neoadjuvant chemotherapy for breast cancer.
Purpose of the Study:
- To assess the efficacy and safety of combining rh-endostatin with neoadjuvant chemotherapy in breast cancer patients.
- To determine the clinical response rate and safety profile of the combination therapy.
- To evaluate the impact on quality of life.
Main Methods:
- A prospective, randomized, controlled, phase II trial.
- Sixty-eight breast cancer patients received 3 cycles of neoadjuvant chemotherapy (DE: docetaxel and epirubicin) or DE plus rh-endostatin.
- Clinical response assessed by Response Evaluation Criteria in Solid Tumors; safety and quality of life were secondary endpoints.
Main Results:
- The objective response rate was significantly higher in the rh-endostatin plus chemotherapy group (90.9%) compared to chemotherapy alone (67.7%) (P=0.021).
- Rh-endostatin showed greater efficacy in premenopausal patients and those with ECOG score of zero.
- No significant differences in quality of life or side effects were observed between the groups.
Conclusions:
- Combination therapy of rh-endostatin and neoadjuvant chemotherapy significantly increases tumor response rates in breast cancer.
- The addition of rh-endostatin does not increase toxicity or negatively affect quality of life.
- Rh-endostatin shows promise as an adjunct to neoadjuvant chemotherapy for breast cancer treatment.
More Related Videos
04:04Endobronchial Ultrasound-guided Intratumoral Injection of Cisplatin for the Treatment of Isolated Mediastinal Recurrence of Lung Cancer
Published on: February 12, 2017
08:57Sample Extraction and Simultaneous Chromatographic Quantitation of Doxorubicin and Mitomycin C Following Drug Combination Delivery in Nanoparticles to Tumor-bearing Mice
Published on: October 5, 2017