NCT02624973

PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Haukeland University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Neoadjuvant tamoxifen + goserelin (premenopausal women)
DRUG	Neoadjuvant letrozole (postmenopausal women)
DRUG	Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone)
DRUG	Neoadjuvant docetaxel + cyclophosphamide
DRUG	Neoadjuvant docetaxel
DRUG	Neoadjuvant docetaxel + trastuzumab + pertuzumab
DRUG	Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab
DRUG	Neoadjuvant olaparib
DRUG	Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone)
PROCEDURE	Breast conserving surgery or mastectomy + SNB/axillary dissection	After response to neoadjuvant treatment
RADIATION	Postoperative radiotherapy breast/chest wall + regional lymph nodes
DRUG	Adjuvant trastuzumab
DRUG	Adjuvant letrozole (postmenopausal women)
DRUG	Adjuvant tamoxifen + goserelin (premenopausal women)
DRUG	Adjuvant palbociclib (if palbociclib given neoadjuvant)
DRUG	Adjuvant Epirubicin+ Cyclophosphamide

Timeline

• Start date: 2016-04-15
• Primary completion: 2020-06-01
• Completion: 2030-06-01
• First posted: 2015-12-09
• Last updated: 2026-02-12

Locations

7 sites across 1 country: Norway