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

February 10, 2026 updated by: Haukeland University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
    • Akershus
      • Lørenskog, Akershus, Norway
        • Akershus University Hospital
    • Hordaland
      • Bergen, Hordaland, Norway, 5021
        • Haukeland University Hospital
    • Rogaland
      • Haugesund, Rogaland, Norway
        • Helse Fonna
      • Stavanger, Rogaland, Norway
        • Helse Stavanger
    • Sogn Og Fjordande
      • Førde, Sogn Og Fjordande, Norway
        • Helse Førde
    • Sør Trøndelag
      • Trondheim, Sør Trøndelag, Norway
        • St. Olavs Hospital
    • Troms
      • Tromsø, Troms, Norway
        • Helse Nord/UNN

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: A
ER/PGR>50% TP53 wt
Drug: Neoadjuvant tamoxifen + goserelin (premenopausal women)
Drug: Neoadjuvant letrozole (postmenopausal women)
Drug: Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy 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 letrozole (postmenopausal women)
Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
Drug: Adjuvant palbociclib (if palbociclib given neoadjuvant)
Drug: Adjuvant Epirubicin+ Cyclophosphamide
Experimental: B
ER/PGR>50% TP53 mutated
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 letrozole (postmenopausal women)
Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
Drug: Neoadjuvant docetaxel + cyclophosphamide
Experimental: C
ER/PGR<50% TP53 wt
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 letrozole (postmenopausal women)
Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
Drug: Neoadjuvant docetaxel
Experimental: D
ER/PGR<50% TP53 mutated
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 letrozole (postmenopausal women)
Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
Drug: Neoadjuvant docetaxel + cyclophosphamide
Experimental: E
HER2+ TP53 wt
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 letrozole (postmenopausal women)
Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
Drug: Neoadjuvant docetaxel + trastuzumab + pertuzumab
Drug: Adjuvant trastuzumab
Experimental: F
HER2+ TP53 mutated
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 letrozole (postmenopausal women)
Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
Drug: Adjuvant trastuzumab
Drug: Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab
Experimental: G
Triple negative breast cancer TP53 wt
Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection
After response to neoadjuvant treatment
Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes
Drug: Neoadjuvant olaparib
Drug: Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone)
Experimental: H
Triple negative breast cancer TP53 mutated
Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection
After response to neoadjuvant treatment
Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes
Drug: Neoadjuvant olaparib
Drug: Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Ten years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Before vs. 16-24 wks after treatment start. Four years: summary of all patients treated.
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
Four years
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
Assessment for each patient after 2 and 5 weeks of treatment. Four years - summary of all patients in arm A.
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
Ten years
To evaluate the percentage of patients completing neoadjuvant treatment and completing surgery
Time Frame: Four years
Secondary endpoint
Four years
Breast conserving surgery rate (potential to avoid mastectomy)
Time Frame: Four years
Secondary endpoint
Four years
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: Ten years
Secondary endpoint
Ten years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Haukeland University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pfizer
AstraZeneca
Helse Vest

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hans Petter Eikesdal, MD PhD, Consultant Oncologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2020

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2015/8463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Tumor genomic data will be made available after publication.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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