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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Helse Bergen HF

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

29 Nov 2024 → ongoing

Decision date (initial)

2024-11-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Helse Vest · Astra Zeneca · Pfizer

External identifiers

EU CT number

2024-519364-40-00

EudraCT number

2015-002816-34

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others

Identify molecular markers of therapy response/resistance and survival outcome.

Secondary objectives 6

1. Objective response rate (ORR), compared to historical data.
2. Tumor Ki67 reduction after 2 and 6 weeks of treatment in Arm A
3. Recurrence-free and overall survival, compared to historical data.
4. Percentage of patients successfully completing neoadjuvant treatment and surgery.
5. Breast conserving surgery rate (potential to avoid mastectomy).
6. Safety and tolerability of the study treatment

Conditions and MedDRA coding

Breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. 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.
2. WHO performance status 0-1
3. Known tumor ER, PGR, HER2 and TP53 status.
4. Known tumor Ki67 percentage (if ER/PGR>50% and TP53 wt status).
5. Known tumor Ki67 percentage (if ER/PGR>50% and TP53 wt status).
6. Distant metastasis not suspected. Patients will undergo radiology exams during screening phase, after signing the informed consent.
7. Age >18 years
8. Patients must have clinically and/or radiographically documented measurable breast cancer according to RECIST.
9. Radiology studies (CT thorax/abdomen and bone scintigraphy/bone scan) must be performed within 28 days prior to registration.
10. 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
11. Before patient registration/randomization, written informed consent must be given according to national and local regulations.
12. 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

Exclusion criteria 8

1. Unstable angina pectoris or heart failure
2. Other co-morbidity that, based on the assessment of the treating physician, may preclude the use of chemotherapy at actual doses.
3. Pregnant or lactating patients can not be included.
4. 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.
5. Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
6. Active cystitis (to be treated upfront)
7. Active bacterial infections
8. Urinary obstruction

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary objective 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.

Secondary endpoints 7

1. To assess how genetic/epigenetic disturbances in tumor tissue change during therapy
2. The objective response rate (ORR) of personalized medicine, compared to ORR for best standard-of-care using historical data for comparison.
3. Tumor Ki67 reduction after 2 and 5 weeks of treatment in Arm A.
4. To estimate recurrence-free and overall survival when patients are treated with the optimal personalized treatment available as of 2016, using historical data for comparison.
5. To evaluate the percentage of patients completing neoadjuvant treatment as outlined in Figure 1 and completing surgery.
6. Breast conserving surgery rate (potential to avoid mastectomy).
7. To assess the safety and tolerability of the study treatment given.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Helse Bergen HF

Sponsor organisation

Helse Bergen HF

Address

Haukelandsveien 22

City

Bergen

Postcode

5021

Country

Norway

Scientific contact point

Organisation

Helse Bergen HF

Contact name

Hanna Elisabet Dillekås

Public contact point

Organisation

Helse Bergen HF

Contact name

Hanna Elisabet Dillekås

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications