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ACTIVE NOT RECRUITING
NCT02624973
PHASE2

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

Sponsor: Haukeland University Hospital

View on ClinicalTrials.gov

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

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

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