Individualized treatment of locally advanced breast cancer based on molecular biomarkers - the PETREMAC trial

PErsonalized TREatment of high-risk MAmmary Cancer - the PETREMAC trial - PETREMAC trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002816-34-NO

Enrollment

200

Registered

2015-10-28

Start date

2016-02-09

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally advanced breast cancer

Interventions

Trade Name: Ibrance Product Name: palbociclib Product Code: PD0332991 Pharmaceutical Form: Tablet Trade Name: Perjeta Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Olaparib-

Eligibility

Sex/Gender

All

Inclusion criteria

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 ULN is accepted if there is no evidence of biliary obstruction. ? Serum creatinine =65 years) yes F.1.3.1 Number of subjects for this age range 50

Exclusion criteria

Exclusion criteria: Unstable angina pectoris or heart failure ? 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Identify molecular markers of therapy response/resistance and survival outcome in patients with locally advanced breast cancer ;Secondary Objective: a)To assess changes in genetic/epigenetic disturbances in tumor tissue during therapy b) The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison. c)Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A. d) 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. e)To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery. f) Breast conserving surgery rate (potential to avoid mastectomy). g)To assess the safety and tolerability of the study treatment given. ;Primary end point(s): The primary endpoint of this trial is to prospectively evaluate the predictive and prognostic value of pre-treatment assessment of a panel of 300 known potential driver mutations in breast cancer by next generation sequencing of tumor DNA.;Timepoint(s) of evaluation of this end point: Annualy	—

Measure

Time frame

Main Objective: Identify molecular markers of therapy response/resistance and survival outcome in patients with locally advanced breast cancer ;Secondary Objective: a)To assess changes in genetic/epigenetic disturbances in tumor tissue during therapy b) The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison. c)Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A. d) 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. e)To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery. f) Breast conserving surgery rate (potential to avoid mastectomy). g)To assess the safety and tolerability of the study treatment given. ;Primary end point(s): The primary endpoint of this trial is to prospectively evaluate the predictive and prognostic value of pre-treatment assessment of a panel of 300 known potential driver mutations in breast cancer by next generation sequencing of tumor DNA.;Timepoint(s) of evaluation of this end point: Annualy

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Secondary

Measure	Time frame
Secondary end point(s): The secondary endpoints of this trial are; a) To assess changes in genetic/epigenetic disturbances in tumor tissue during therapy b) The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison. c) Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A. d) 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. e) To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery. f) Breast conserving surgery rate (potential to avoid mastectomy). g) To assess the safety and tolerability of the study treatment given. ;Timepoint(s) of evaluation of this end point: Side effects: continously. Efficacy of treatment: interim analysis after first 100 patients, estimated to be after 2 yrs	—

Measure

Time frame

Secondary end point(s): The secondary endpoints of this trial are; a) To assess changes in genetic/epigenetic disturbances in tumor tissue during therapy b) The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison. c) Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A. d) 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. e) To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery. f) Breast conserving surgery rate (potential to avoid mastectomy). g) To assess the safety and tolerability of the study treatment given. ;Timepoint(s) of evaluation of this end point: Side effects: continously. Efficacy of treatment: interim analysis after first 100 patients, estimated to be after 2 yrs

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Countries

Norway

Contacts

Public ContactReseach and development dept

Helse Bergen, Haukeland University Hospital

postmottak@helse-bergen.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026