Breast CancerPhase 2DespaTILNCT07074106
TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC
A Phase 2 study testing Carboplatin and a Taxane in people with Breast Cancer, run by D'Or Institute for Research and Education at 5 sites in Brazil.
Trial summary
This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carboplatin and a Taxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 5 sitesBrazil
- Study dates
- 31 Oct 2025to 1 Jul 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary invasive breast carcinoma.
- One of the following conditions:
- Clinical stage T1c N0 M0 with any level of TILs; or
- Clinical stage T2 N0 M0 with TILs ≥ 50%.
- Estrogen receptor (ER) and progesterone receptor (PR) expression < 10%.
- HER2-negative or non-amplified, according to current ASCO-CAP criteria.
Show all 10Show fewer
- No evidence of distant metastasis based on imaging performed prior to study entry (chest/abdomen/pelvis CT scan or FDG PET-CT).
- Age ≥ 18 years.
- ECOG performance status of 0 to 2.
- Adequate organ function
Who cannot join
- The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), active ischemic heart disease, or chronic liver or kidney disease.
- Pregnant or breastfeeding participants.
- History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Intituto D'Or de Pesquisa e Ensino São Paulo contact
5 sites in 1 country
Brazil5 sites, 5 recruiting
- Recruiting
Instituto D'Or de Pesquisa e Ensino de Brasília
Brasília
pesquisaclinica@idor.org, oncologia.projetos@idor.org
- Not yet recruiting
Instituto D'Or de Pesquisa e Ensino de Curitiba
Curitiba
pesquisaclinica@idor.org, oncologia.projetos@idor.org
- Recruiting
Instituto D'Or de Pesquisa e Ensino do Rio de Janeiro
Rio de Janeiro
pesquisaclinica@idor.org, oncologia.projetos@idor.org
- Recruiting
Instituto D'Or de Pesquisa e Ensino de Salvador
Salvador
pesquisaclinica@idor.org, oncologia.projetos@idor.org
- Recruiting
Instituto D'Or de Pesquisa e Ensino de São Paulo
São Paulo
pesquisaclinica@idor.org, oncologia.projetos@idor.org
About this study
Official title: DespaTIL Study: A Phase II Trial of De-escalated Neoadjuvant Chemotherapy for Early-Stage Triple-Negative Breast Cancer Guided by Tumor-Infiltrating Lymphocytes (TILs) and Radiologic Response
This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment.
Patients with stage I triple-negative breast cancer (regardless of TIL levels) and those with stage II disease and high TILs (50% or more) will receive a combination of two chemotherapy drugs (carboplatin and a taxane) for four cycles.
Read more
If imaging shows the tumor has completely disappeared after this treatment, the patient will go straight to surgery. If the tumor is still visible, the treatment will be strengthened with additional chemotherapy drugs (anthracycline and cyclophosphamide), with or without a medicine called pembrolizumab, which helps the immune system fight cancer.
The main goal of the study is to see how many patients have a complete disappearance of the cancer after treatment. Other goals include understanding how imaging results relate to what is found during surgery and tracking how long patients live without the cancer coming back.
Read the detailed description
This is a phase II, single-arm clinical trial investigating a de-escalated neoadjuvant chemotherapy regimen for stage I and II triple-negative breast cancer (TNBC), guided by tumor-infiltrating lymphocytes (TILs) and radiologic response.
Patients with stage I TNBC (regardless of TIL levels) and stage II TNBC with TILs ≥ 50% will receive four cycles of carboplatin and a taxane. Those who achieve a complete radiologic response will proceed to surgery, while patients without a complete radiologic response will be escalated to a regimen including anthracycline and cyclophosphamide, with or without pembrolizumab.
The primary objective is to evaluate the pathological complete response rate. Secondary outcomes include the correlation between radiologic and pathologic response, event-free survival, and overall survival.
- Conditions
- Breast Cancer
- Being tested
- Carboplatin and a Taxane
- Keywords
- TILs, Breast cancer, radiological response, Descalonation of neoadjuvant treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboplatin and a TaxaneDrug
All patients will receive Carboplatin and a Taxane for 4 cycles.
- Patients who achieve a complete radiological response will proceed directly to surgery.
- Patients without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Carboplatin and Taxane - 4 Cycles | Experimental | All patients will receive Carboplatin and a Taxane for 4 cycles. Patients who achieve a complete radiological response will proceed directly to surgery. Those without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery. Receives: Drug: Carboplatin and a Taxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response rate after 4 cycles of Carboplatin plus Paclitaxel.
Measured: 3 mo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2025
- Study start31 Oct 2025
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Collaborators
- Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07074106
- Sponsor's protocol ID
- 831-25-ONCOLOGIA-IDOR-SP-M-I
- Acronym
- DespaTIL
- Status last verified
- Mar 2026
- First submitted
- 9 Jul 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DespaTIL Study: A Phase II Trial of De-escalated Neoadjuvant Chemotherapy for Early-Stage Triple-Negative Breast Cancer Guided by Tumor-Infiltrating Lymphocytes (TILs) and Radiologic Response
- ClinicalTrials.gov ID
- NCT07074106
- Acronym / sponsor ID
- DespaTIL / 831-25-ONCOLOGIA-IDOR-SP-M-I
- Conditions
- Breast Cancer
- Keywords
- TILs, Breast cancer, radiological response, Descalonation of neoadjuvant treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Collaborators
- Grupo Brasileiro de Estudos do Câncer de Mama (GBECAM)
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 20 Jul 2025 (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 is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment.
Patients with stage I triple-negative breast cancer (regardless of TIL levels) and those with stage II disease and high TILs (50% or more) will receive a combination of two chemotherapy drugs (carboplatin and a taxane) for four cycles.
If imaging shows the tumor has completely disappeared after this treatment, the patient will go straight to surgery. If the tumor is still visible, the treatment will be strengthened with additional chemotherapy drugs (anthracycline and cyclophosphamide), with or without a medicine called pembrolizumab, which helps the immune system fight cancer.
The main goal of the study is to see how many patients have a complete disappearance of the cancer after treatment. Other goals include understanding how imaging results relate to what is found during surgery and tracking how long patients live without the cancer coming back.
Detailed description
This is a phase II, single-arm clinical trial investigating a de-escalated neoadjuvant chemotherapy regimen for stage I and II triple-negative breast cancer (TNBC), guided by tumor-infiltrating lymphocytes (TILs) and radiologic response.
Patients with stage I TNBC (regardless of TIL levels) and stage II TNBC with TILs ≥ 50% will receive four cycles of carboplatin and a taxane. Those who achieve a complete radiologic response will proceed to surgery, while patients without a complete radiologic response will be escalated to a regimen including anthracycline and cyclophosphamide, with or without pembrolizumab.
The primary objective is to evaluate the pathological complete response rate. Secondary outcomes include the correlation between radiologic and pathologic response, event-free survival, and overall survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carboplatin and Taxane - 4 Cycles | Experimental | Drug: Carboplatin and a TaxaneAll patients will receive Carboplatin and a Taxane for 4 cycles. Patients who achieve a complete radiological response will proceed directly to surgery. Those without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Histologically confirmed primary invasive breast carcinoma.
- One of the following conditions:
- Clinical stage T1c N0 M0 with any level of TILs; or
- Clinical stage T2 N0 M0 with TILs ≥ 50%.
- Estrogen receptor (ER) and progesterone receptor (PR) expression < 10%.
Key exclusion criteria (3 listed)
- The subject has an uncontrolled severe concomitant condition, including but not limited to: active or ongoing infection, unstable angina, uncontrolled cardiac arrhythmia, congestive heart failure (NYHA Class III or IV), active ischemic heart disease, or chronic liver or kidney disease.
- Pregnant or breastfeeding participants.
- History of severe allergic reactions, including anaphylaxis or other hypersensitivity reactions to platinum-based agents or taxanes.
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 |
|---|---|---|
| Carboplatin and a TaxaneAll patients will receive Carboplatin and a Taxane for 4 cycles. * Patients who achieve a complete radiological response will proceed directly to surgery. * Patients without a complete radiological response will receive Doxorubicin and Cyclophosphamide, with or without Pembrolizumab, for an additional 4 cycles before surgery. | Drug | Carboplatin and Taxane - 4 Cycles |
Primary outcome
Pathological complete response rate after 4 cycles of Carboplatin plus Paclitaxel.
Time frame: 3 mo
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 1 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Intituto D'Or de Pesquisa e Ensino São Paulo contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Carboplatin and a Taxane in people with Breast Cancer, run by D'Or Institute for Research and Education at 5 sites in Brazil.
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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Intituto D'Or de Pesquisa e Ensino São Paulo (pesquisaclinica@idor.org, oncologia.projetos@idor.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response rate after 4 cycles of Carboplatin plus Paclitaxel. (time frame: 3 mo). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Apr 2026.