Clinical trial · Interventional
Trial of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in HER2-negative Breast Cancer
An Open-label Phase II Trial Evaluating the Efficacy and Safety of Neoadjuvant EndoTAG-1 in Combination With Paclitaxel in Patients With HER2-negative Breast Cancer
NCT01537536CI-TRIAL-00010731EndoTAG-1completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study hypothesis is that the new drug EndoTAG-1 will improve tumor volume reduction as measured by Magnetic Resonance Imaging when added to a standard chemotherapy regimen of weekly paclitaxel. This is a prospective single-center study that will investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative breast cancer that are candidate for receiving chemotherapy before surgery (neoadjuvant chemotherapy).
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EndoTAG-1 | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- EndoTAG-1
- description
- Weekly treatment with EndoTAG-1 (22 mg/m2) plus paclitaxel (70 mg/m2) for 12 weeks (ET+P) followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery.
- interventionNames
- Drug: EndoTAG-1
Primary outcomes (1)
- measure
- MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
- timeFrame
- 15 weeks after start of neoadjuvant chemotherapy.
- description
- To investigate the activity of EndoTAG-1 + paclitaxel combination therapy in patients with HER2-negative BC candidate for neoadjuvant chemotherapy, as measured by the decrease in MRI-estimated tumour volume at the end of neoadjuvant EndoTAG-1 + paclitaxel administration vs. baseline.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. newly diagnosed histologically confirmed BC with breast infiltrating carcinoma of histological grade \> 1 (either operable, or locally advanced or inflammatory) candidate for neoadjuvant chemotherapy 2. HER2-negative tumor, defined according to immunohistochemistry or using fluorescent in-situ hybridization (FISH) 3. ECOG performance status 0 or 1 4. Gender: female 5. Age : \>= 18 years old 6. Negative pregnancy test (females of childbearing potential) 7. Willingness to perform double-barrier-contraception during study and for 6 months post chemotherapy treatment (females of childbearing potential) 8. Signed informed consent Exclusion Criteria: 1. Metastatic or relapsed disease 2. Major surgery \< 3 weeks prior to enrollment 3. Severe pulmonary obstructive or restrictive disease 4. Uncontrolled inflammatory disease (autoimmune or infectious) 5. Clinically significant cardiac disease (NYHA stadium \> 2) 6. Results of laboratory tests (hematology, chemistry) outside specified limits: * WBC ≤ 3 x 109/L * ANC \< 1.5 x 109/L * Platelets \< 100 x 109/L * Hb ≤ 9.0 g/dl (≤ 5.6 mmol/l) * PTT/ INR \> 1.5 x ULN * AST or ALT \> 2.5 x ULN * Alkaline Phosphatase \> 2 x ULN * Total Bilirubin \> 1.5 x ULN 7. Pregnancy or nursing status 8. Known positive HIV testing 9. Known hypersensitivity to any component of the EndoTAG-1, paclitaxel or FEC formulations 10. History of malignancy other than breast cancer \< 5 years prior to enrollment, except skin cancer (i.e. basal or squamous cell carcinoma) treated locally 11. History of active or significant neurological disorder or psychiatric disorder that would prohibit the understanding and giving of informed consent, or would interfere in the clinical and radiological evaluation of central nervous system during the trial 12. Concurrent treatment with other experimental products. Participation in another clinical trial with any investigational product within 30 days prior to study entry
References
Publications (1)
- DERIVEDIgnatiadis M, Zardavas D, Lemort M, Wilke C, Vanderbeeken MC, D'Hondt V, De Azambuja E, Gombos A, Lebrun F, Dal Lago L, Bustin F, Maetens M, Ameye L, Veys I, Michiels S, Paesmans M, Larsimont D, Sotiriou C, Nogaret JM, Piccart M, Awada A. Feasibility Study of EndoTAG-1, a Tumor Endothelial Targeting Agent, in Combination with Paclitaxel followed by FEC as Induction Therapy in HER2-Negative Breast Cancer. PLoS One. 2016 Jul 25;11(7):e0154009. doi: 10.1371/journal.pone.0154009. eCollection 2016. PMID 27454930