Clinical trial NCT02810743: Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer
Official title: Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer Patients with Personalized Therapy (SUBITO) - an International Randomized Phase III Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Stage III
HER2 negative
homologous recombination deficiency (HRD)
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigator-initiated, international, multicentre, randomized, open-label, (neo)adjuvant phase III study in target population (stage III, HER2-negative, BRCA1-like breast cancer patients) comparing optimized standard-dose chemotherapy with intensified, alkylating chemotherapy with stem cell rescue.


Eligibility criteria: Inclusion Criteria:

* Women and men with stage III adenocarcinoma of the breast harboring signs of a breast cancer with features of homologous recombination deficiency (HRD)
* Age of 18-65 years
* The tumor must be HER2-negative
* Treatment must start within 8 weeks after the last surgical resection
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1

Exclusion Criteria:

* Previous radiation therapy
* Previous chemotherapy
* Any previous treatment with a PARP-inhibitor, including olaparib
* Pre-existing neuropathy from any cause in excess of Grade 1
* Chronic concomitant use of known strong or moderate CYP3A inducers

Primary outcomes:
measure: Overall survival in all patients
timeFrame: assessed up to 120 months
Secondary outcomes:
measure: Overall survival in patients without a germline BRCA1/2 mutation
timeFrame: assessed up to 120 months
measure: Recurrence free interval in all patients
timeFrame: assessed up to 120 months
measure: Recurrence free interval in patients with an HR impaired tumor
timeFrame: assessed up to 120 months
measure: Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03
timeFrame: up to 30 days after end of treatment
measure: cost-effectiveness measured by costs per quality-adjusted life years (QALYs)
timeFrame: assessed up to 120 months
measure: Patient reported outcomes
timeFrame: assessed up to 24 months
measure: cost-effectiveness measured by incremental cost-effectiveness ratio (ICER)
timeFrame: assessed up to 120 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Paris
country: France
facility: Hopital Tenon, University Marie-Curie
city: Enschede
country: Netherlands
facility: Medical spectrum Twente
state: Overijssel
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Amsterdam
country: Netherlands
facility: AZVU
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: LUMC
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
city: NIjmegen
country: Netherlands
facility: Radboud UMC
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center Cancer Institute
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: NKI-AvL
name: Sabine Linn, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References: