A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early
PROMIX
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.
2 other identifiers
interventional
151
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Sep 2008
Longer than P75 for phase_2 breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 10, 2009
CompletedFirst Posted
Study publicly available on registry
August 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedSeptember 8, 2016
September 1, 2016
3.2 years
August 10, 2009
September 6, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 weeks
Secondary Outcomes (5)
Identification of tumour characteristics and treatment-related changes of tumour characteristics predictive of long-term prognosis.
5 years
Comparison between the standard evaluation procedures mammography, conventional ultrasound and clinical examination and functional imaging techniques and biological procedures with emphasis on detection of response at an early point of treatment.
6 weeks
Studies on the addition of bevacizumab with regard to further improvement of response in tumours with stable (SD) or partial response (PR) and the impact of treatment on angiogenesis and local features of the tumour environment.
6 weeks
Acute toxicity
6 weeks after last chemotherapy
Late toxicity
5 years after last chemotherapy
Study Arms (1)
Epirubicin Docetaxel Bevacizumab
EXPERIMENTALEpirubicin 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.
Interventions
75 mg/m2 i.v. infusion, 30 min, cycle day 1, cycles 1-6.
75 mg/m2 i.v. infusion, 60 min, cycles day 1, cycle 1-6.
15 mg/kg, i.v. infusion, 90 min, cycle day 1, cycles 3-6 if PR or SD after cycle 2.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Thomas Hatscheklead
Study Sites (6)
Sahlgrenska University Hospital
Gothenburg, Sweden
Lund University Hospital
Lund, Sweden
Malmö General University Hospital
Malmo, Sweden
Karolinska University Hospital, Dept of Oncology
Stockholm, SE-17176, Sweden
County Hospital
Sundsvall, Sweden
Uppsala University Hospital
Uppsala, Sweden
Related Publications (3)
Saracco 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: 27461224RESULTTribukait 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: 32423477DERIVEDNakamura 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: 29078273DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Hatschek, MD, PhD
Karolinska University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
August 10, 2009
First Posted
August 12, 2009
Study Start
September 1, 2008
Primary Completion
November 1, 2011
Study Completion
November 1, 2016
Last Updated
September 8, 2016
Record last verified: 2016-09