Breast Cancer (Early Breast Cancer)MCarb-TNCT07821229

Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in BRCA-associated Triple-negative Locally Advanced Breast Cancer

A study testing Neoadjuvant Chemotherapy (NACT) in people with Breast Cancer (Early Breast Cancer) and BRCA 1 Gene Mutation, run by N.N. Petrov National Medical Research Center of Oncology at 1 site in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 to 70 years, women only
Conditions the study is for: Breast Cancer (Early Breast Cancer), BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
What is being tested?: Neoadjuvant Chemotherapy (NACT)
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteRussia
Study dates: 27 Sep 2022to 1 Dec 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Signed informed consent to participate in the study;
Histopathological confirmation of triple-negative breast cancer;
Stage: clinical T1-T4, N0-3, M0;
Positive molecular genetic test for BRCA1|2 gene mutation (PCR test or NGS result);
Age > 18 years;
ECOG status 0-1.

Who cannot join

Prior administration of any systemic therapy for breast cancer;
Stage IV disease;
Severe uncontrolled chronic comorbidities or acute illnesses;
Renal dysfunction;
Age > 70 years;
Presence of a second malignant tumor (except for previously cured malignancies);
Pregnancy or breastfeeding;
Negative molecular genetic test for BRCA1|2 gene mutation

Trial locations and contacts

1 site in 1 country.

Russia1 site

N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, 197758

Other trials in Russia

About this study

Official title: Use of a Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in Patients With BRCA-associated Triple-negative Locally Advanced Breast Cancer

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.

Read the detailed description

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.

Conditions: Breast Cancer (Early Breast Cancer), BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Being tested: Neoadjuvant Chemotherapy (NACT)
Keywords: BRCA-associated triple-negative early breast cancer, mitomycin, germline mutation BRCA1, BRCA2
Medical subject headings: Breast Neoplasms, Fanconi Anemia, Complementation Group D1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Neoadjuvant Chemotherapy (NACT)Procedure or surgery
neoadjuvant chemotherapy according to the regimen of mitomycin in combination with carboplatin, followed by paclitaxel
Neoadjuvant Chemotherapy (NACT)Procedure or surgery
neoadjuvant chemotherapy according to the AC regimen, followed by paclitaxel in combination with carboplatin

Study groups in NCT07821229
Study group	Role	What they receive
MCarb - T (mitomycin + carboplatin, paclitaxel)	Experimental	mitomycin at a dose of 10 mg/m2, carboplatin AUC5, paclitaxel 80 mg/m2 Receives: Procedure: Neoadjuvant Chemotherapy (NACT)
AC - TCarb (doxorubicin + cyclophosphamide, paclitaxel + carboplatin)	Active comparator	doxorubicin at a dose of 60 mg/m2, cyclophosphamide 600 mg/m2, paclitaxel 80 mg/m2, carboplatin AUC2 Receives: Procedure: Neoadjuvant Chemotherapy (NACT)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From enrollment to pathological assessment (after surgery) from 6 to 7 months

Secondary outcomes (3)

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.
Measured: Until 30 days after last patient treatment visit
Response rate
To assess the objective response rate (OR) by RECIST v1.1 2.
Measured: 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.
Measured: "through study completion, an average of 1 year"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Sep 20221 Dec 2030

First posted15 Sep 2026
Study start27 Sep 2022
Primary completion1 Dec 2030 (estimated)
Study completion1 Dec 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast Cancer (Early Breast Cancer)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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 o
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07821229
Sponsor's protocol ID: 928080
Other IDs: 9/280
Acronym: MCarb-T
Status last verified: Sep 2026
First submitted: 6 May 2026
Last updated: 15 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Use of a Combination of Mitomycin and Carboplatin in Neoadjuvant Therapy in Patients With BRCA-associated Triple-negative Locally Advanced Breast Cancer
ClinicalTrials.gov ID: NCT07821229
Acronym / sponsor ID: MCarb-T / 928080
Conditions: Breast Cancer (Early Breast Cancer), BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Keywords: BRCA-associated triple-negative early breast cancer, mitomycin, germline mutation BRCA1, BRCA2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: N.N. Petrov National Medical Research Center of OncologyUniversity, hospital or other
Study start: 27 Sep 2022 (actual)
Primary completion: 1 Dec 2030 (estimated)
Study completion: 1 Dec 2030 (estimated)
First posted: 15 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: 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 o

Arm	Type	Receives
MCarb - T (mitomycin + carboplatin, paclitaxel)	Experimental	Procedure: Neoadjuvant Chemotherapy (NACT)mitomycin at a dose of 10 mg/m2, carboplatin AUC5, paclitaxel 80 mg/m2
AC - TCarb (doxorubicin + cyclophosphamide, paclitaxel + carboplatin)	Active comparator	Procedure: Neoadjuvant Chemotherapy (NACT)doxorubicin at a dose of 60 mg/m2, cyclophosphamide 600 mg/m2, paclitaxel 80 mg/m2, carboplatin AUC2

Who may qualify

Ages: 18 to 70 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Signed informed consent to participate in the study;
Histopathological confirmation of triple-negative breast cancer;
Stage: clinical T1-T4, N0-3, M0;
Positive molecular genetic test for BRCA1|2 gene mutation (PCR test or NGS result);
Age > 18 years;

Key exclusion criteria (8 listed)

Prior administration of any systemic therapy for breast cancer;
Stage IV disease;
Severe uncontrolled chronic comorbidities or acute illnesses;
Renal dysfunction;
Age > 70 years;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Neoadjuvant Chemotherapy (NACT)neoadjuvant chemotherapy according to the regimen of mitomycin in combination with carboplatin, followed by paclitaxel	Procedure or surgery	MCarb - T (mitomycin + carboplatin, paclitaxel)
Neoadjuvant Chemotherapy (NACT)neoadjuvant chemotherapy according to the AC regimen, followed by paclitaxel in combination with carboplatin	Procedure or surgery	AC - TCarb (doxorubicin + cyclophosphamide, paclitaxel + carboplatin)

Primary outcome

Pathomorphological response
Time frame: From enrollment to pathological assessment (after surgery) from 6 to 7 months
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.

3 secondary outcomes

Adverse events incidence
Time frame: Until 30 days after last patient treatment visit
Response rate
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
Time frame: "through study completion, an average of 1 year"

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
Individual participant dataSharing planned: Yes

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathomorphological response (time frame: From enrollment to pathological assessment (after surgery) from 6 to 7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07821229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.