Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer

Breast Cancer Clinical Trial

— Subito  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02810743
• Other study ID #: M16BRC
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: January 25, 2017
• Est. completion date: December 1, 2033

Study information

• Verified date: March 2024
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: December 1, 2033
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• ddAC-CP-Olaparib
ddAC-CP-Olaparib
• ddAC-mini CTC
ddAC - mini CTC

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille
France	Hopital Tenon, University Marie-Curie	Paris
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	AZVU	Amsterdam
Netherlands	Medical spectrum Twente	Enschede	Overijssel
Netherlands	University Medical Center Groningen	Groningen
Netherlands	LUMC	Leiden
Netherlands	Maastricht University Medical Center	Maastricht
Netherlands	Radboud UMC	NIjmegen
Netherlands	Erasmus Medical Center Cancer Institute	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Countries where clinical trial is conducted

France,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	time from randomization to death from any cause.	assessed up to 120 months
Secondary	Recurrence free interval	time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first	assessed up to 120 months
Secondary	Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03	Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03	up to 30 days after end of treatment
Secondary	cost-effectiveness measured by costs per quality-adjusted life years (QALYs)	cost-effectiveness measured by costs per quality-adjusted life years (QALYs)	assessed up to 120 months
Secondary	Patient reported outcomes	Patient reported outcomes; including quality of life (QoL) determined by a comprehensive panel of QoL questionnaires	assessed up to 24 months
Secondary	cost-effectiveness measured by incremental cost-effectiveness ratio (ICER)	cost-effectiveness measured by incremental cost-effectiveness ratio (ICER)	assessed up to 120 months