An interventional study of Neoadjuvant Chemotherapy (NACT) and Neoadjuvant Chemotherapy (NACT) in Breast Cancer (Early Breast Cancer), BRCA 1 Gene Mutation and BRCA 2 Gene Mutation, sponsored by N.N. Petrov National Medical Research Center of Oncology. Active, not recruiting at 1 site in Russia. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by N.N. Petrov National Medical Research Center of Oncology · Not applicable, Interventional, and Treatment
Among 79 studies in Breast Neoplasms with a site in Russia — 12 open to participants now, 48 under way, 24 of them phase 3. Breast Neoplasms · Russia.
Among the 79 studies in Breast Neoplasms with a site in Russia, this one is the 53rd largest by planned enrollment of the 64 interventional ones that give a count, is one of 6 that started in 2022, is one of 8 with no phase, reaches primary completion later than 45 of the 47 other live ones, and was the 76th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
Browse Breast Neoplasms studies →12 of the 79 studies in Breast Neoplasms with a site in Russia are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Russia
Novartis Pharmaceuticals · Sites in Russia
Kidney Cancer Research Bureau · Sites in Russia
Blokhin's Russian Cancer Research Center · Sites in Russia
The Leningrad Regional Clinical Hospital · Sites in Russia
A study can be open while its sites in Russia have not opened yet or have stopped. Only those recruiting at a site in Russia →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 70 Years · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 13 · Phase 2 17 · Phase 3 30 · Phase 4 1
First in 2005; this study’s year is marked. 6 started in 2022.
This study's planned enrollment of 30 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Median enrollment 246 across the 64 interventional studies, 329 across the 15 observational. Of the 30 that completed or were terminated, 13 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
51 of 79 have an industry lead sponsor. The 10 most frequent:
N.N. Petrov National Medical Research Center of Oncology is the lead sponsor of 27 studies on the registry; 15 are open to participants now.
N.N. Petrov National Medical Research Center of Oncology has 6 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
11 of the studies in Breast Neoplasms with a site in Russia that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
| NCT04421963Phase 3AstraZenecaRoll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib | 2027-04-06 |
| NCT04784715Phase 3AstraZenecaTrastuzumab Deruxtecan (T-DXd) With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer (DESTINY-Breast09) | 2027-05-03 |
| NCT07457541Tomsk National Research Medical Center of the Russian Academy of SciencesMolecular Imaging of Fibroblast Activation Protein Expression Using Labeled Technetium-99m HYNIC-FAPI | 2026-12-31 |
| NCT06043947N.N. Petrov National Medical Research Center of OncologySurvival Monitoring in Russian Cancer Registries | 2026-12-31 |
Among the 79 studies in Breast Neoplasms with a site in Russia, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study was designed to evaluate the safety and efficacy of neoadjuvant therapy with mitomycin and carboplatin in patients with BRCA-associated locally advanced triple-negative breast cancer.
The study includes two groups: one is an experimental group receiving chemotherapy according to the MCarb-T regimen, which is compared to a control group treated with the standard AC-TCarb regimen. To participate in this study, patients must have histologically confirmed triple-negative breast cancer (TNBC) in a locally advanced stage and a germline BRCA1 or BRCA2 mutation. All patients with TNBC undergo BRCA1/BRCA2 mutation testing before starting treatment, using either polymerase chain reaction (PCR) or next-generation sequencing (NGS).
Patients in the experimental group receive 4 cycles of neoadjuvant chemotherapy with the MCarb regimen (mitomycin + carboplatin AUC5), followed by 12 weekly doses of paclitaxel. Patients in the control group receive 4 cycles of neoadjuvant chemotherapy with the AC regimen (doxorubicin + cyclophosphamide), followed by 12 weekly administrations of the TCarb regimen (paclitaxel + carboplatin AUC2).
Clinical assessment is performed after cycles 2 and 4 of MCarb/AC, as well as after completion of the 12 weekly doses of T/ TCarb, with response evaluation according to RECIST 1.1 criteria.
Upon completion of cytotoxic chemotherapy, patients undergo surgical treatment. Resected specimens are evaluated using the Miller-Payne grading system and the Residual Cancer Burden (RCB) classification to determine the efficacy of systemic therapy.
To assess the safety of neoadjuvant systemic therapy, the frequency and nature of adverse events are recorded during treatment using the NCI CTCAE version 5.0 criteria. As part of the study protocol, complete blood counts with differential and platelet counts (Fonio method) were performed every 7 days, while blood biochemistry, urinalysis, and coagulation tests were carried out every 14 days.
After completion of protocol therapy, patients were followed to assess disease status every 3 months during the first year and every 6 months thereafter. Monitoring included physical examination, ultrasound of the breasts and regional lymph nodes, mammography, contrast-enhanced computed tomography of the chest and abdomen, ultrasound or contrast-enhanced magnetic resonance imaging of the pelvis, and bone scintigraphy.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
mitomycin at a dose of 10 mg/m2, carboplatin AUC5, paclitaxel 80 mg/m2
Procedure: Neoadjuvant Chemotherapy (NACT)
doxorubicin at a dose of 60 mg/m2, cyclophosphamide 600 mg/m2, paclitaxel 80 mg/m2, carboplatin AUC2
Procedure: Neoadjuvant Chemotherapy (NACT)
neoadjuvant chemotherapy according to the regimen of mitomycin in combination with carboplatin, followed by paclitaxel
neoadjuvant chemotherapy according to the AC regimen, followed by paclitaxel in combination with carboplatin
Pathomorphological response
The pathological response assessment will be performed within 14 days after definitive breast surgery. The Miller-Payne grading system will be used to assess the pathological response in the surgical specimen by comparing residual invasive tumor cellularity with the pretreatment core needle biopsy specimen. The Residual Cancer Burden (RCB) will be assessed using the surgical specimens from the breast and regional lymph nodes and will also be calculated within 14 days after surgery.
Time frame: From enrollment to pathological assessment (after surgery) from 6 to 7 months
Adverse events incidence
Adverse events during chemotherapy are any undesirable symptoms, conditions, or diseases that occur in a patient during or after chemotherapy and may be related to its toxic effects.
Time frame: Until 30 days after last patient treatment visit
Response rate
To assess the objective response rate (OR) by RECIST v1.1 2.
Time frame: At the end of Cycle 2 (each cycle consists of 28 days). At the end of Cycle 4 (each cycle consists of 28 days). At the end of Cycle 6 (each cycle consists of 7 days). At the end of Cycle 12 (each cycle consists of 7 days).
overall and disease-free survival
Overall survival (OS) refers to the length of time from either the date of diagnosis or the start of treatment that patients are still alive. It is a key endpoint in clinical trials, measuring the effectiveness of a treatment in extending life. Disease-free survival (DFS) is the length of time after primary treatment during which a patient remains free of any signs or symptoms of the cancer. It is used to measure how well a treatment prevents recurrence.
Time frame: "through study completion, an average of 1 year"
Plan to share: Yes
Supporting information: Clinical study report
No publications or documents are linked to this record.
Started Sep 2022 (actual). Primary completion is estimated for Dec 2030, 98 months after the start.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 98 months is above that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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N.N. Petrov National Medical Research Center of Oncology