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NCT Number: NCT02810743

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Paoli Calmettes, Marseille, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ddAC-CP-Olaparib

Drug

ddAC-CP-Olaparib

ddAC-mini CTC

Drug

ddAC - mini CTC

Primary outcomes

  1. Overall survival in all patients

    Time frame: assessed up to 120 months

    time from randomization to death from any cause in all patients

Secondary outcomes

  1. Overall survival in patients without a germline BRCA1/2 mutation

    Time frame: assessed up to 120 months

    time from randomization to death from any cause in without a germline BRCA1/2 mutation

  2. Recurrence free interval in all patients

    Time frame: assessed up to 120 months

    time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first in all patients

  3. Recurrence free interval in patients with an HR impaired tumor

    Time frame: assessed up to 120 months

    time from randomization to local recurrence, second primary, distant recurrence or death, whichever comes first in patients with an HR impaired tumor

  4. Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03

    Time frame: up to 30 days after end of treatment

    Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03

  5. cost-effectiveness measured by costs per quality-adjusted life years (QALYs)

    Time frame: assessed up to 120 months

    cost-effectiveness measured by costs per quality-adjusted life years (QALYs)

  6. Patient reported outcomes

    Time frame: assessed up to 24 months

    Patient reported outcomes; including quality of life (QoL) determined by a comprehensive panel of QoL questionnaires

  7. cost-effectiveness measured by incremental cost-effectiveness ratio (ICER)

    Time frame: assessed up to 120 months

    cost-effectiveness measured by incremental cost-effectiveness ratio (ICER)

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer Patients With Personalized Therapy (SUBITO) - an International Randomized Phase III Trial

Acronym: Subito

Important dates

Study start
2017
Primary completion
2024
Study completion
2033
First posted
Jun 23, 2016
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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