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PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial
Sponsor: Haukeland University Hospital
Summary
Breast cancer is an optimal "model disease" for studying personalized medicine. Breast cancer was the first malignancy for which a predictive factor forecasting response to therapy was identified nearly 50 years ago; the expression of the estrogen receptor (ER). Furthermore, breast cancer is by far the malignancy in which prognostic and predictive factors have been most extensively studied. Primary medical treatment (pre-surgical medical therapy) offers a unique setting to explore predictive factors due to the fact that primary breast cancers are easily accessible to repeated tissue sampling and evaluation of therapy response both clinically and radiologically. For many years, the investigators have studied predictive factors in primary medical treatment of breast cancer. In the present project, the investigators will implement a new trial concept where the current knowledge from previous trials with respect to predictive markers (hormone receptors, HER2; TP53, CHEK2 and RB1), will be combined with massive parallel sequencing (MPS). Thereby, the investigators aim to design the "next-generation" primary medical treatment where 1) therapy regimens are individualized based on a limited number of known predictive factors and, 2) MPS is used to explore additional predictive factors and their co-regulators in order to fully identify the mechanisms of drug sensitivity / resistance across individual tumours and pave the way for further personalized breast cancer therapy in the future. As for the new era of "genomic medicine", the current trial concept will allow individual tumours to be characterized by their unique gene mutation / epigenetic modification profile upfront, to allocate patients to their optimal personalized medicine as compared to "classical" drug testing through phase II/III trials.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2016-04-15
Completion Date
2030-06
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Neoadjuvant tamoxifen + goserelin (premenopausal women)
Neoadjuvant letrozole (postmenopausal women)
Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone)
Neoadjuvant docetaxel + cyclophosphamide
Neoadjuvant docetaxel
Neoadjuvant docetaxel + trastuzumab + pertuzumab
Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab
Neoadjuvant olaparib
Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone)
Breast conserving surgery or mastectomy + SNB/axillary dissection
After response to neoadjuvant treatment
Postoperative radiotherapy breast/chest wall + regional lymph nodes
Adjuvant trastuzumab
Adjuvant letrozole (postmenopausal women)
Adjuvant tamoxifen + goserelin (premenopausal women)
Adjuvant palbociclib (if palbociclib given neoadjuvant)
Adjuvant Epirubicin+ Cyclophosphamide
Locations (7)
Akershus University Hospital
Lørenskog, Akershus, Norway
Haukeland University Hospital
Bergen, Hordaland, Norway
Helse Fonna
Haugesund, Rogaland, Norway
Helse Stavanger
Stavanger, Rogaland, Norway
Helse Førde
Førde, Sogn Og Fjordande, Norway
St. Olavs Hospital
Trondheim, Sør Trøndelag, Norway
Helse Nord/UNN
Tromsø, Troms, Norway