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

Plain-language summary

This study is evaluating personalized pre-surgery (neoadjuvant) treatments for high-risk breast cancer based on the genetic and biological features of the tumor; the drugs used include tamoxifen, letrozole, palbociclib, docetaxel, trastuzumab, and olaparib. It enrolled adults with previously untreated, non-inflammatory breast cancer larger than 4 cm. The study is in Phase 2 and is not currently recruiting but is ongoing (active, not recruiting).

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Active, not recruiting

Sponsor

Haukeland University Hospital

Intervention

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, Neoadjuvant docetaxel + trastuzumab + pertuzumab, Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab, Neoadjuvant olaparib, Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone), Breast conserving surgery or mastectomy + SNB/axillary dissection, Postoperative radiotherapy breast/chest wall + regional lymph nodes, Adjuvant trastuzumab, Adjuvant letrozole (postmenopausal women), Adjuvant tamoxifen + goserelin (premenopausal women), Adjuvant palbociclib (if palbociclib given neoadjuvant), Adjuvant Epirubicin+ Cyclophosphamide

Start date

4/15/2016

Estimated completion

6/1/2030

Countries

Norway

Related genes

Locations

• Lørenskog, Norway
• Bergen, Norway
• Haugesund, Norway
• Stavanger, Norway
• Førde, Norway
• Trondheim, Norway
• Tromsø, Norway

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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