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

NCT02624973

Last updated date
Study Location
Akershus University Hospital
Lørenskog, Akershus, , Norway
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial
Official Title  ICMJE PErsonalized TREatment of High-risk MAmmary Cancer - the PETREMAC Trial
Brief 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). 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: 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 + cyclophosphamide
  • Drug: Neoadjuvant docetaxel
  • Drug: Neoadjuvant docetaxel + trastuzumab + pertuzumab
  • Drug: Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab
  • Drug: Neoadjuvant olaparib
  • Drug: Neoadjuvant cyclophosphamide (after 10 weeks of olaparib 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 trastuzumab
  • Drug: Adjuvant letrozole (postmenopausal women)
  • Drug: Adjuvant tamoxifen + goserelin (premenopausal women)
  • Drug: Adjuvant palbociclib (if palbociclib given neoadjuvant)
  • Drug: Adjuvant Epirubicin+ Cyclophosphamide
Study Arms  ICMJE
  • Experimental: A
    ER/PGR>50% TP53 wt
    Interventions:
    • 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
  • Experimental: B
    ER/PGR>50% TP53 mutated
    Interventions:
    • 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)
  • Experimental: C
    ER/PGR<50% TP53 wt
    Interventions:
    • 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)
  • Experimental: D
    ER/PGR<50% TP53 mutated
    Interventions:
    • 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)
  • Experimental: E
    HER2+ TP53 wt
    Interventions:
    • 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)
  • Experimental: F
    HER2+ TP53 mutated
    Interventions:
    • 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)
  • Experimental: G
    Triple negative breast cancer TP53 wt
    Interventions:
    • 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
  • Experimental: H
    Triple negative breast cancer TP53 mutated
    Interventions:
    • 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
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, Balmaña J, Serra V, Janssen EAM, Knappskog S, Lønning 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: December 4, 2015)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2030
Actual Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02624973
Other Study ID Numbers  ICMJE 2015/8463
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Tumor genomic data will be made available after publication.
Responsible Party Haukeland University Hospital
Study Sponsor  ICMJE Haukeland University Hospital
Collaborators  ICMJE
  • Helse Vest
  • Pfizer
  • AstraZeneca
Investigators  ICMJE
Principal Investigator:Hans Petter Eikesdal, MD PhDConsultant oncologist
PRS Account Haukeland University Hospital
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP