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PErsonalized TREatment of high-risk MAmmary Cancer - the PETREMAC trial
EU CTIS ID: 2024-519364-40-00
What this study is testing
Identify molecular markers of therapy response/resistance and survival outcome.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Previously untreated, histologically confirmed non-inflammatory breast cancer, >4 cm in diameter when evaluated clinically +/- metastatic ipsilateral axillary deposits for which the smallest diameter of the largest node >2 cm by CT or ultrasound scan. For patients with HER2 positive and triple negative breast cancers in Arms E-H the requirement is a tumor size >2 cm, and the tumor must be located so that repeated biopsies can be taken.
- 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: 1) Neutrophils > 1.5 x 109/L, 2) Platelets > 100 x 109/L, 3) 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. 4) Serum creatinine < 1.5 x ULN. 5) ALT and Alk Phos (ALP) <2.5 x ULN
- WHO performance status 0-1
- Known tumor ER, PGR, HER2 and TP53 status.
You likely can't join if
- 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)
See the full eligibility criteria
Who can join
- Previously untreated, histologically confirmed non-inflammatory breast cancer, >4 cm in diameter when evaluated clinically +/- metastatic ipsilateral axillary deposits for which the smallest diameter of the largest node >2 cm by CT or ultrasound scan. For patients with HER2 positive and triple negative breast cancers in Arms E-H the requirement is a tumor size >2 cm, and the tumor must be located so that repeated biopsies can be taken.
- 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: 1) Neutrophils > 1.5 x 109/L, 2) Platelets > 100 x 109/L, 3) 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. 4) Serum creatinine < 1.5 x ULN. 5) ALT and Alk Phos (ALP) <2.5 x ULN
- 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).
- 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.
What rules you out
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.