Breast Cancer Clinical Trial
Official title:
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.
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.
Primary endpoints: Objective response (OR) characterized by conventional radiological and
functional imaging procedures and biological tumour markers at an early point of treatment
with epirubicin + docetaxel and effects of addition of bevacizumab as reflected by these
procedures. Early functional and biological changes signalling pathological complete
response (pCR). Secondary endpoints: Secondary endpoints: Morphological and biological
changes of tumours exposed for cytotoxic and targeted treatment. Disease-free survival.
Safety.
Evaluations:
Before start of treatment:
Tumour staging: Bone scan, chest X-ray and liver ultrasound or CT scan of chest and abdomen
within four weeks before start of treatment. Physical examination, conventional radiology
(ultrasound and mammography including pre-treatment localization with carbon suspension) and
functional imaging procedure (MRI or PET-CT or Contrast-Enhanced Ultrasound (CEUS) or
Scintigraphy with 99m-Tc-HMPAO (Ceretec)) within two weeks before start of treatment.
Blood samples (SNP, metabolomics, M-30 assay, TK/XPA-210 assay, angiogenesis markers,
TIMP-1, tissue factor) and tumour biopsies (transcriptomics, proteomics, IHC-stroma, AMOT)
are collected within two weeks before start of treatment.
During treatment:
Physical examination before start of each treatment. Imaging procedures: Mammography,
ultrasound (compulsory) one week (5-9 days) after cycles 2, 4 and 6. MRI, PET-CT,
Contrast-Enhanced Ultrasound (CEUS) applied according to availability at the participating
sites, one week (5-9 days) after cycles 2 and 4.
Tumour markers: Blood samples (proteomics, metabolomics, M-30 assay, TK/XPA-210 assay,
angiogenesis markers, TIMP-1, tissue factor) are collected 48 hours after cycles 1 thru 4.
Tumour tissue (transcriptomics, proteomics, IHC-stroma, AMOT) is taken charge of by biopsy
one week (5-9 days) after cycle 2 and from the tumour specimen in connection with surgery.
Totally, 150-200 patients with measurable/evaluable primary breast cancer are planned for
inclusion within a period of two years time. For each imaging method, approximately 40-50
patients will be included. The study is designed to find early predictors of response by
testing a set-up of several different molecular and imaging tools. In addition, for each
method changes of patterns occurring during treatment will be compared to baseline findings
and, in the case of functional imaging, standard imaging procedures.
All patients will be followed for five years after operation with regard to outcome and
toxicity.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 |