Clinical trial · Interventional
Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab and Chemotherapy in Breast Cancer
Phase II" Proof of Concept " Trial Evaluating Anti Cancer Stem Cell Activity of Pre-operative Bevacizumab in Combination With Chemotherapy in Breast Cancer
- 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 purpose of this study is to evaluate anti-cancer stem cell (CSC) activity (measured by the amount of Aldehyde dehydrogenase 1/ALDH1+ cells before and after treatment) of pre-operative bevacizumab in combination with conventional chemotherapy in breast cancer receiving neo-adjuvant treatment, compared to a control arm receiving chemotherapy alone.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| no bevacizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- WITH bevacizumab
- description
- bevacizumab 15 mg/kg on day 1 of each cycle : 4 cycles of 5-fluorouracil 500 mg/m² IV + epirubicin 100 mg/m² IV + cyclophosphamide 500 mg/m² IV (FEC100) every 21 days and 4 cycles of docetaxel 100 mg/m² IV every 21 days. Patients with HER2+ disease will receive trastuzumab (8 mg/kg (IV then 6 mg/kg, every 21 days), which will be started with docetaxel and administered for a total duration of 54 weeks, 18 injections.
- interventionNames
- Drug: bevacizumab
- type
- ACTIVE_COMPARATOR
- label
- without bevacizumab
- description
- 4 cycles 5-fluorouracil 500 mg/m² IV + epirubicin 100 mg/m² IV + cyclophosphamide 500 mg/m² IV of (FEC100) every 21 days and 4 cycles of docetaxel 100 mg/m² IV every 21 days. Patients with HER2+ disease will receive trastuzumab (8 mg/kg (IV then 6 mg/kg, every 21 days), which will be started with docetaxel and administered for a total duration of 54 weeks, 18 injections.
- interventionNames
- Drug: no bevacizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women older than 18 ys * Primary breast cancer treated in the neoadjuvant setting (synchronous metastatic disease are eligible) * Primary breast tumor accessible to initial biopsy * White Blood Count \> 3.000/µl and Absolute neutrophil count ≥ 1.500/µl AND platelets ≥ 100 x 109/L AND Hemoglobin ≥ 9 g/dL, Serum creatinine ≤ 150µm/l• Urine dipstick for proteinuria \< 2+. Patients discovered to have ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate ≤ 1 g of protein in 24 hours, Total bilirubin ≤ 1.5 ULN and ASAT \< 2.5 ULN AND ALAT \< 1.5 ULN (2.5 if liver metastasis), Adequate coagulation function: International normalized ratio (INR) ≤ 1.5 and TCA ≤ 1.5 x ULN * Left ventricular ejection fraction (LVEF) ≥ 55% (isotopic or * ultrasound methods) * Karnofsky Index \> 1 ; Performance status 0 to 1 * Patients must have signed a written informed consent form prior to any study specific screening procedures * Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen. Exclusion Criteria: * Previous history of cancer (other than curatively treated basal and squamous cell carcinoma of the skin and/or in-situ carcinoma of the cervix) relapsing within the 5 years before study entry * Known contra-indication to anticancer compounds used * Uncontrolled hypertension (systolic \>150 mmHg and/or diastolic \>100 mmHg) or history of hypertensive encephalopathy * History of inherited diathesis or recent thrombotic events * Non-healing wound, active peptic ulcer or bone fracture. * Major surgery or significant traumatic injury within 28 days prior to study treatment start * History of abdominal fistula, trachea-oesophageal fistula or urinary fistula * Use of Non Steroid Anti Inflammatory or full dose anticoagulants or antiaggregation treatments within 10 days * Pregnancy and breast feeding, premenopausal patient and no effective contraception * Brain metastasis. * Any unstable severe disease such as : uncontrolled cardiac or vascular disease, uncontrolled hemorrhagy, uncontrolled neuropsychiatric disorders, including dementia, uncontrolled infection or any severe disorders that may preclude study participation * Patient considered geographically, socially or psychologically unable to comply with the treatment and the required medical follow-up.
References
Publications (0)
Data not yet available