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Substantially improving the cure rate of high-risk BRCA1-like breast cancer patients with personalized therapy (SUBITO) - an international randomized phase III trial
EU CTIS ID: 2024-516196-32-00
What this study is testing
To investigate whether neoadjuvant systemic treatment of intensified alkylating chemotherapy with peripheral stem cell rescue (mCTC) (and adjuvant capecitabine for patients without (near) pathologic complete response) compared to AC-CP chemotherapy (and adjuvant capecitabine for patients without (near) pathologic complete response) followed by 1-year olaparib monotherapy substantially improves overall survival (OS) in patients with stage III, HER2-negative, HR impaired or HR deficient breast cancer.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Males or females ≥18 and <66 years of age and fit to undergo autologous stem cell transplantation
- Histologically confirmed adenocarcinoma of the breast
- The tumor must be: HER2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 at immunohistochemistry);AND Hormone receptor negative; or in case of a histological grade III tumor an estrogen receptor of <50% and progesterone receptor of <50% (Unless BRCA1 or BRCA2 germline mutation carrier)
- Patients treated in the neoadjuvant setting
- Women and men with stage III adenocarcinoma of the breast (according to AJCC staging manual 7th edition; Stage IIIA: T0-2N2 or T3N1-2; Stage IIIB: T4N0-2; Stage IIIC: any TN3) harboring signs of a breast cancer with features of homologous recombination deficiency (HRD) Based on the results of the preliminary work, the following HRD working definition will be employed: The patient is a known BRCA1 or BRCA2 mutation carrier; and/or the tumor exhibits a BRCA1 promoter hypermethylation, and/or the tumor exhibits a BRCA1-like DNA copy number profile
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
You likely can't join if
- Evidence of distant metastases
- Previous radiation therapy
- Previous chemotherapy (except for ddAC cycles 1-3 for the current breast cancer, or another third generation chemotherapy cycle 1
- Any previous treatment with a PARP-inhibitor, including olaparib
- Pre-existing neuropathy from any cause > Grade 1
- Pregnant; or breastfeeding and not willing to stop breastfeeding in order to be able to participate in the study
See the full eligibility criteria
- Males or females ≥18 and <66 years of age and fit to undergo autologous stem cell transplantation
- Histologically confirmed adenocarcinoma of the breast
- The tumor must be: HER2-negative (either score 0 or 1 at immunohistochemistry or negative at in situ hybridization [CISH or FISH] in case of score 2 at immunohistochemistry);AND Hormone receptor negative; or in case of a histological grade III tumor an estrogen receptor of <50% and progesterone receptor of <50% (Unless BRCA1 or BRCA2 germline mutation carrier)
- Patients treated in the neoadjuvant setting
- Women and men with stage III adenocarcinoma of the breast (according to AJCC staging manual 7th edition; Stage IIIA: T0-2N2 or T3N1-2; Stage IIIB: T4N0-2; Stage IIIC: any TN3) harboring signs of a breast cancer with features of homologous recombination deficiency (HRD) Based on the results of the preliminary work, the following HRD working definition will be employed: The patient is a known BRCA1 or BRCA2 mutation carrier; and/or the tumor exhibits a BRCA1 promoter hypermethylation, and/or the tumor exhibits a BRCA1-like DNA copy number profile
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Provision of informed consent
- Evidence of distant metastases
- Previous radiation therapy
- Previous chemotherapy (except for ddAC cycles 1-3 for the current breast cancer, or another third generation chemotherapy cycle 1
- Any previous treatment with a PARP-inhibitor, including olaparib
- Pre-existing neuropathy from any cause > Grade 1
- Pregnant; or breastfeeding and not willing to stop breastfeeding in order to be able to participate in the study
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.