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Breast CancerPhase 2PETREMACNCT02624973

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

A Phase 2 study testing Neoadjuvant tamoxifen + goserelin (premenopausal women), Neoadjuvant letrozole (postmenopausal women) and Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone) in people with Breast Cancer, run by Haukeland University Hospital at 7 sites in Norway.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Neoadjuvant tamoxifen + goserelin (premenopausal women), Neoadjuvant letrozole (postmenopausal women) and Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
7 sitesNorway
Study dates
15 Apr 2016to Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 17Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Norway7 sites

  • Haukeland University Hospital

    Bergen, Hordaland, 5021

  • Helse Førde

    Førde, Sogn Og Fjordande

  • Helse Fonna

    Haugesund, Rogaland

  • Akershus University Hospital

    Lørenskog, Akershus

  • Helse Stavanger

    Stavanger, Rogaland

  • Helse Nord/UNN

    Tromsø, Troms

  • St. Olavs Hospital

    Trondheim, Sør Trøndelag

Other trials in Norway

About this study

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
Being tested
Neoadjuvant tamoxifen + goserelin (premenopausal women), Neoadjuvant letrozole (postmenopausal women), Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone), Neoadjuvant docetaxel + cyclophosphamide, Neoadjuvant docetaxel
Keywords
neoadjuvant treatment, personalized medicine
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 + cyclophosphamideDrug

  • Neoadjuvant docetaxelDrug

  • Neoadjuvant docetaxel + trastuzumab + pertuzumabDrug

  • Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumabDrug

  • Neoadjuvant olaparibDrug

  • Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone)Drug

  • Breast conserving surgery or mastectomy + SNB/axillary dissectionProcedure or surgery

    After response to neoadjuvant treatment

  • Postoperative radiotherapy breast/chest wall + regional lymph nodesRadiation

  • Adjuvant trastuzumabDrug

  • Adjuvant letrozole (postmenopausal women)Drug

  • Adjuvant tamoxifen + goserelin (premenopausal women)Drug

  • Adjuvant palbociclib (if palbociclib given neoadjuvant)Drug

  • Adjuvant Epirubicin+ CyclophosphamideDrug

Study groups in NCT02624973
Study groupRoleWhat they receive
AExperimentalER/PGR>50% TP53 wt
Receives: 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; 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
BExperimentalER/PGR>50% TP53 mutated
Receives: Drug: Neoadjuvant docetaxel + cyclophosphamide; Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection; Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes; Drug: Adjuvant letrozole (postmenopausal women); Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
CExperimentalER/PGR<50% TP53 wt
Receives: Drug: Neoadjuvant docetaxel; Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection; Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes; Drug: Adjuvant letrozole (postmenopausal women); Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
DExperimentalER/PGR<50% TP53 mutated
Receives: Drug: Neoadjuvant docetaxel + cyclophosphamide; Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection; Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes; Drug: Adjuvant letrozole (postmenopausal women); Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
EExperimentalHER2+ TP53 wt
Receives: Drug: Neoadjuvant docetaxel + trastuzumab + pertuzumab; Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection; Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes; Drug: Adjuvant trastuzumab; Drug: Adjuvant letrozole (postmenopausal women); Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
FExperimentalHER2+ TP53 mutated
Receives: Drug: Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab; Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection; Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes; Drug: Adjuvant trastuzumab; Drug: Adjuvant letrozole (postmenopausal women); Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
GExperimentalTriple negative breast cancer TP53 wt
Receives: Drug: Neoadjuvant olaparib; Drug: Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone); Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection; Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes
HExperimentalTriple negative breast cancer TP53 mutated
Receives: Drug: Neoadjuvant olaparib; Drug: Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone); Procedure: Breast conserving surgery or mastectomy + SNB/axillary dissection; Radiation: Postoperative radiotherapy breast/chest wall + regional lymph nodes

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Primary endpoint

    Measured: Ten years

Secondary outcomes (7)

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

    Secondary endpoint

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

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

    Secondary endpoint

    Measured: Four years

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

    Secondary endpoint

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

  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

    Secondary endpoint

    Measured: Ten years

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

    Secondary endpoint

    Measured: Four years

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

    Secondary endpoint

    Measured: Four years

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

    Secondary endpoint

    Measured: Ten years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study start15 Apr 2016
  3. Primary completion1 Jun 2020
  4. Study completionJun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02624973
Sponsor's protocol ID
2015/8463
Acronym
PETREMAC
Status last verified
Feb 2026
First submitted
30 Nov 2015
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes: Tumor genomic data will be made available after publication.

Publications

  • Eikesdal HP, Yndestad S, Elzawahry A, Llop-Guevara A, Gilje B, Blix ES, Espelid H, Lundgren S, Geisler J, Vagstad G, Venizelos A, Minsaas L, Leirvaag B, Gudlaugsson EG, Vintermyr OK, Aase HS, Aas T, Balmana J, Serra V, Janssen EAM, Knappskog S, Lonning PE. Olaparib monotherapy as primary treatment in unselected triple negative breast cancer. Ann Oncol. 2021 Feb;32(2):240-249. doi: 10.1016/j.annonc.2020.11.009. Epub 2020 Nov 24.

    PubMed 33242536

  • Yndestad S, Engebrethsen C, Herencia-Ropero A, Nikolaienko O, Vintermyr OK, Lillestol RK, Minsaas L, Leirvaag B, Iversen GT, Gilje B, Blix ES, Espelid H, Lundgren S, Geisler J, Aase HS, Aas T, Gudlaugsson EG, Llop-Guevara A, Serra V, Janssen EAM, Lonning PE, Knappskog S, Eikesdal HP. Homologous Recombination Deficiency Across Subtypes of Primary Breast Cancer. JCO Precis Oncol. 2023 Sep;7:e2300338. doi: 10.1200/PO.23.00338.

    PubMed 38039432

  • Wang L, Wang D, Sonzogni O, Ke S, Wang Q, Thavamani A, Batalini F, Stopka SA, Regan MS, Vandal S, Tian S, Pinto J, Cyr AM, Bret-Mounet VC, Baquer G, Eikesdal HP, Yuan M, Asara JM, Heng YJ, Bai P, Agar NYR, Wulf GM. PARP-inhibition reprograms macrophages toward an anti-tumor phenotype. Cell Rep. 2022 Oct 11;41(2):111462. doi: 10.1016/j.celrep.2022.111462.

    PubMed 36223740

  • Batalini F, Gulhan DC, Mao V, Tran A, Polak M, Xiong N, Tayob N, Tung NM, Winer EP, Mayer EL, Knappskog S, Lonning PE, Matulonis UA, Konstantinopoulos PA, Solit DB, Won H, Eikesdal HP, Park PJ, Wulf GM. Mutational Signature 3 Detected from Clinical Panel Sequencing is Associated with Responses to Olaparib in Breast and Ovarian Cancers. Clin Cancer Res. 2022 Nov 1;28(21):4714-4723. doi: 10.1158/1078-0432.CCR-22-0749.

    PubMed 36048535

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neoadjuvant tamoxifen + goserelin (premenopausal women), Neoadjuvant letrozole (postmenopausal women) and Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone) in people with Breast Cancer, run by Haukeland University Hospital at 7 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02624973, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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