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

Sponsor
Haukeland University Hospital
Study ID
NCT02624973
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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) — DRUG
  • Breast conserving surgery or mastectomy + SNB/axillary dissection — PROCEDURE
    After response to neoadjuvant treatment
  • Postoperative radiotherapy breast/chest wall + regional lymph nodes — RADIATION
  • Adjuvant trastuzumab — DRUG
  • Adjuvant letrozole (postmenopausal women) — DRUG
  • Adjuvant tamoxifen + goserelin (premenopausal women) — DRUG
  • Adjuvant palbociclib (if palbociclib given neoadjuvant) — DRUG
  • Adjuvant Epirubicin+ Cyclophosphamide — DRUG

Study Details

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 Dates

Start date
Apr 15, 2016
Status verified
Feb 2026
Primary completion
Jun 1, 2020
Completion
Jun 30, 2030

Study Design

Enrollment
200 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: A
    ER/PGR\>50% TP53 wt
  • Experimental: B
    ER/PGR\>50% TP53 mutated
  • Experimental: C
    ER/PGR\<50% TP53 wt
  • Experimental: D
    ER/PGR\<50% TP53 mutated
  • Experimental: E
    HER2+ TP53 wt
  • Experimental: F
    HER2+ TP53 mutated
  • Experimental: G
    Triple negative breast cancer TP53 wt
  • Experimental: H
    Triple negative breast cancer TP53 mutated

Primary Outcome Measure

Predictive and prognostic value of mutations in 300 cancer-related genes assessed in breast cancer tissue by next generation sequencing before starting neoadjuvant therapy. [ Time Frame: Ten years ]

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