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NCT Number: NCT02624973

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Akershus University Hospital, Lørenskog, Akershus, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previously untreated, histologically confirmed non-inflammatory breast cancer, >4 cm in diameter and /or metastatic ipsilateral axillary deposits for which the smallest diameter of the largest node >2 cm by CT or ultrasound scan.
  • WHO performance status 0-1
  • Known tumor ER, PGR, HER2 and TP53 status.
  • Known tumor Ki67 percentage (if ER/PGR>50% and TP53 wt status).
  • Distant metastasis not suspected. Patients will undergo radiology exams during screening phase, after signing the informed consent.
  • Age >18 years
  • Patients must have clinically and/or radiographically documented measurable breast cancer according to RECIST.
  • Radiology studies (CT thorax/abdomen and bone scintigraphy/bone scan) must be performed within 28 days prior to registration.
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
  • Before patient registration/randomization, written informed consent must be given according to national and local regulations.
  • For arms B-H:
  • Neutrophils > 1.5 x 109/L
  • Platelets > 100 x 109/L
  • Bilirubin < 2 x upper limit normal (ULN). For patients with Gilbert´s syndrome bilirubin >2 x ULN is accepted if there is no evidence of biliary obstruction.
  • Serum creatinine < 1.5 x ULN
  • ALT and Alk Phos (ALP) <2.5 x ULN
  • INR < 1.5

Exclusion criteria

  • Unstable angina pectoris or heart failure
  • Other co-morbidity that, based on the assessment of the treating physician, may preclude the use of chemotherapy at actual doses.
  • Pregnant or lactating patients can not be included.
  • Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
  • Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
  • Active cystitis (to be treated upfront)
  • Active bacterial infections
  • Urinary obstruction

Treatment and study plan

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

Primary outcomes

  1. 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

    Primary endpoint

Secondary outcomes

  1. To assess genetic/epigenetic changes within the tumor tissue during therapy

    Time frame: Before vs. 16-24 wks after treatment start. Four years: summary of all patients treated.

    Secondary endpoint

  2. The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison

    Time frame: Four years

    Secondary endpoint

  3. Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A

    Time frame: Assessment for each patient after 2 and 5 weeks of treatment. Four years - summary of all patients in arm A.

    Secondary endpoint

  4. To estimate recurrence-free and overall survival when patients are treated with the optimal personalized treatment available as of 2015, using historical data for comparison

    Time frame: Ten years

    Secondary endpoint

  5. To evaluate the percentage of patients completing neoadjuvant treatment and completing surgery

    Time frame: Four years

    Secondary endpoint

  6. Breast conserving surgery rate (potential to avoid mastectomy)

    Time frame: Four years

    Secondary endpoint

  7. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: Ten years

    Secondary endpoint

Sponsors and collaborators

Lead sponsor

Haukeland University Hospital

Other

Collaborators

  • AstraZeneca
  • Helse Vest
  • Pfizer

Registry information

Acronym: PETREMAC

Important dates

Study start
2016
Primary completion
2020
Study completion
2030
First posted
Dec 9, 2015
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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