Clinical trial · Interventional
A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early
PROMIX - Preoperative Treatment of Breast Cancer With a Combination of Epirubicin, Docetaxel and Bevacizumab. A Translational Trial on Molecular Markers and Functional Imaging to Predict Response Early. A Phase 2 Study.
- 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)
Patients with localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases receive six cycles of chemotherapy with epirubicin and docetaxel. Treatment evaluations are performed after the second, fourth and sixth cycle. In case of SD/PR after the second course, bevacizumab is added to the combination for the remaining four courses. Besides standard response evaluation clinically and by mammography and ultrasound, several functional imaging techniques including MR, CT-PET and contrast-enhanced ultrasound are investigated. Fresh tumor tissue samples from the primary tumor are collected before start, after two courses and in connection with surgery. The aim of the trial is to detect biological factors and functional imaging techniques with the ability to predict response at an early stage of treatment.
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 |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Docetaxel | Drug | Docetaxel | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Epirubicin Docetaxel Bevacizumab
- description
- Epirubicin and docetaxel i.v. infusion q 3 weeks for 2 cycles. * If complete response this treatment continues for 4 cycles, totally 6 cycles. * If partial response or stable disease, epirubicin and docetaxel and bevacizumab i.v. infusion q 3 weeks for 4 cycles. * If progressive disease after the first 2 cycles individualized treatment.
- interventionNames
- Drug: Epirubicin
- Drug: Docetaxel
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Evaluation of the sensitivity and of defined diagnostic and biological procedures to detect response/non-response to neoadjuvant treatment at an early point among patients with breast cancer.
- timeFrame
- 6 weeks
Secondary outcomes (5)
- measure
- Identification of tumour characteristics and treatment-related changes of tumour characteristics predictive of long-term prognosis.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent * Female patients with breast cancer confirmed by histology. * Tumour and blood samples according to APPENDIX I available. * Age 18 years or older. Elderly patients in condition adequate for chemotherapy. * Localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases including ipsilateral supraclavicular nodes with breast cancer diagnosis confirmed by histological examination with or without breast tumour lesions. * Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders. * ECOG performance status 0-1. * Patients in child-bearing age with adequate contraception. Exclusion Criteria: * Distant metastases, including node metastases in the contralateral breast region and in the mediastina. * Other malignancy for the last two years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. * HER2-amplification verified by FISH analysis. * Pregnancy or lactation. * Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders. * Recent history of thromboembolism and ongoing medication with full-dose anticoagulants. * Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment. * Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion. * History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding. * Non-healing wound, active peptic ulcer or bone fracture. * History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment.
References
Publications (3)
- RESULTSaracco A, Szabo BK, Tanczos E, Bergh J, Hatschek T. Contrast-enhanced ultrasound (CEUS) in assessing early response among patients with invasive breast cancer undergoing neoadjuvant chemotherapy. Acta Radiol. 2017 Apr;58(4):394-402. doi: 10.1177/0284185116658322. Epub 2016 Jul 28. PMID 27461224
- DERIVEDTribukait B. Early prediction of pathologic response to neoadjuvant treatment of breast cancer: use of a cell-loss metric based on serum thymidine kinase 1 and tumour volume. BMC Cancer. 2020 May 18;20(1):440. doi: 10.1186/s12885-020-06925-y. PMID 32423477
- DERIVEDNakamura M, Zhang Y, Yang Y, Sonmez C, Zheng W, Huang G, Seki T, Iwamoto H, Ding B, Yin L, Foukakis T, Hatschek T, Li X, Hosaka K, Li J, Yu G, Wang X, Liu Y, Cao Y. Off-tumor targets compromise antiangiogenic drug sensitivity by inducing kidney erythropoietin production. Proc Natl Acad Sci U S A. 2017 Nov 7;114(45):E9635-E9644. doi: 10.1073/pnas.1703431114. Epub 2017 Oct 23. PMID 29078273