Triple-Negative Breast Cancer (TNBC)Phase 2DETENTE-1NCT07786428
Tailored Neoadjuvant Chemoimmunotherapy for Stage I TNBC
A Phase 2 study testing Pembrolizumab, Paclitaxel (Chemotherapy) and Carboplatin in people with Triple-Negative Breast Cancer (TNBC), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare the effectiveness of several treatment regimens for stage I triple negative breast cancer before surgery. The main question it aims to answer is if these regimens will reduce or completely remove all cancer cells before surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- Pembrolizumab, Paclitaxel (Chemotherapy) and Carboplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 31 Oct 2030
- 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
- Must have histologically confirmed invasive triple negative breast cancer as defined by ER/PR <10% and HER2 negative by ASCO/CAP criteria or disease consistent with TNBC by physician assessment, with confirmation by study PI.
- Must have untreated, non-metastatic (M0), cT1 (T1a-T1c) N0 disease. Biopsies of suspicious lymph nodes to confirm nodal status are required.
- Bilateral or multifocal disease can be included as long as all areas have been biopsied and are consistent with invasive triple negative breast cancer. In the case of bilateral or multifocal disease, the tumor with the most advanced T stage should be used to assess eligibility.
- The patient must be ≥ 18 years of age on day of signing informed consent.
- Male participants must agree to use a contraception as detailed in Appendix A of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
- A female participant is eligible to participate if she is not pregnant (see Appendix A), not breastfeeding, and if at least one of the following conditions apply:
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- Not a WOCBP as defined in Appendix A; -OR-
- A WOCBP who agrees to follow the contraceptive guidance in Appendix A during the treatment period and for at least 6 months after the last dose of study treatment.
- The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
- Provides adequate archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue. Note: If submitting unstained cut slides, newly cut slides should be submitted to the testing laboratory within 14 days from the date slides are cut (see Section 9.3).
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Patients living with HIV must have well-controlled HIV on ART, defined as:
- CD4 count ≥350 cells/mm3 at time of screening
- Must have achieved and maintained virologic suppression. This is defined as an HIV RNA level below 50 or the lower limit of detection using the locally available assay at the time of screening and for at least 12 weeks before screening.
- It is advised that participants must not have had any AIDS-defining opportunistic infections within the past 12 months
- Participants on ART must have been on a stable regimen, without changes in drugs or dose modifications, for at least 4 weeks before study entry (Day 1) and agree to continue ART throughout the study
- The combination ART regimen must not contain any anti-retroviral medications that interact with CYP3A4 inhibitors/inducers/substrates (https://www.fda.gov/drugs/drug-interactions-labeling/drug-development-and- drug-interactions-table-substrates-inhibitors-and-inducers)
- Participants who have a history of hepatitis B surface antigen positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on antiviral therapy throughout study interventions and follow local guidelines for HBV antiviral therapy post completion of study intervention.
- Participants with history of hepatitis C virus infection are eligible if HCV viral load is undetectable at screening. Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization.
- Have adequate organ function
Who cannot join
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see Appendix A). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Has received systemic anti-cancer therapy, including investigational agents, prior to randomization.
- If the participant has received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Has received radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines is allowed.
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- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- o Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Has a known additional malignancy (other than their current breast cancer diagnosis) that is progressing or has required active systemic treatment within the past 3 years.
- o Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids within the previous 5 years or has current pneumonitis/interstitial lung disease.
- Has an active infection requiring systemic therapy.
- Has a known history of active mycobacterium tuberculosis.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance use disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant, breastfeeding, or is expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Has significant cardiovascular disease, such as:
- History of myocardial infarction, acute coronary syndrome or coronary angioplasty/stenting/bypass grafting within the last 6 months
- Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA class III or IV
- Angina pectoris requiring anti-anginal medication, uncontrolled arrhythmias, or uncontrolled hypertension (systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥ 100mmHg).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Meredith Carter, MS, 214-648-7097, Meredith.Carter@UTSouthwestern.edu
About this study
Official title: A Phase 2 Randomized Pilot Study to Develop Tailored Neoadjuvant Chemoimmunotherapy Strategies in Stage I Triple-negative Breast Cancer (DETENTE-1)
The goal of this clinical trial is to compare the effectiveness of several treatment regimens for stage I triple negative breast cancer before surgery. The main question it aims to answer is if these regimens will reduce or completely remove all cancer cells before surgery.
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- Pembrolizumab, Paclitaxel (Chemotherapy), Carboplatin
- Keywords
- Breast, DÉTENTE-1, neoadjuvant chemoimmunotherapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Also called Keytruda
Pembrolizumab 200 mg fixed dose IV once every 3 weeks
Paclitaxel (Chemotherapy)Drug
Also called Taxol
Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle
CarboplatinDrug
Also called Paraplatin
Carboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab | Experimental | Pembrolizumab 200 mg fixed dose IV once every 3 weeks administered on Day 1 of each Cycle Receives: Drug: Pembrolizumab |
| Paclitaxel + Carboplatin | Experimental | Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle AND
Carboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle Receives: Drug: Paclitaxel (Chemotherapy); Drug: Carboplatin |
| Pembrolizumab + Paclitaxel + Carboplatin | Experimental | Pembrolizumab 200 mg fixed dose IV once every 3 weeks administered on Day 1 of each Cycle AND
Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle AND Carboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle Receives: Drug: Pembrolizumab; Drug: Paclitaxel (Chemotherapy); Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pathologic complete response (pCR)
To describe rates of pCR in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel-pembrolizumab.
pCR is defined as the absence of residual invasive cancer in the breast and all sampled regional lymph nodes following neoadjuvant therapy. It is assessed by histopathologic examination.
Measured: Enrollment to surgery at 12 weeks
Secondary outcomes (5)
Residual disease burden
To describe residual disease burden at time of surgery in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel-pembrolizumab.
Residual disease will be assessed by histopathologic examination. It is measured by the residual cancer burden index (Residual Cancer Burden Calculator): https://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3
Measured: Enrollment to surgery at 12 weeks
Rate of treatment discontinuation
To assess the rate of treatment discontinuation due to poor response for each treatment arm prior to cycle 3.
To describe the rate of treatment discontinuation in each arm, which is defined as the proportion of patients that are removed from study at interval imaging due to Poor Response compared to the total number of patients treated on the arm.
Measured: Enrollment to 6 weeks
Assess 3-year invasive disease-free survival (IDFS)
To assess 3-year invasive disease-free survival (IDFS) in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel-pembrolizumab.
IDFS will be defined by the Neo-STEEP (Standardized Definitions for Efficacy End Points) system for adjuvant breast cancer trials.
Measured: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Treatment-related adverse events
To describe treatment-related adverse events in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin- paclitaxel-pembrolizumab.
These will be defined and graded by the NCI's CTCAE (Common Terminology Criteria for Adverse Events) version 6.0.
Measured: Start of study treatment (cycle 1 day 1) until 30 days after the last dose of study treatment.
3-year overall survival (OS)
To assess overall survival in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel- pembrolizumab.
To estimate the 3-year overall survival (OS). OS will be defined in accordance with Neo- STEEP criteria to be the time from randomization to death from breast cancer, death from non-breast cancer causes or death from unknown cause.
Measured: From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Oct 2029 (estimated)
- Study completion31 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Gruber, University of Texas Southwestern Medical Center
- Investigators
- Joshua Gruber, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07786428
- Sponsor's protocol ID
- STU20261119
- Acronym
- DETENTE-1
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Pilot Study to Develop Tailored Neoadjuvant Chemoimmunotherapy Strategies in Stage I Triple-negative Breast Cancer (DETENTE-1)
- ClinicalTrials.gov ID
- NCT07786428
- Acronym / sponsor ID
- DETENTE-1 / STU20261119
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Keywords
- Breast, DÉTENTE-1, neoadjuvant chemoimmunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Oct 2029 (estimated)
- Study completion
- 31 Oct 2030 (estimated)
- First posted
- 26 Aug 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.
The goal of this clinical trial is to compare the effectiveness of several treatment regimens for stage I triple negative breast cancer before surgery. The main question it aims to answer is if these regimens will reduce or completely remove all cancer cells before surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab | Experimental | Drug: PembrolizumabPembrolizumab 200 mg fixed dose IV once every 3 weeks administered on Day 1 of each Cycle |
| Paclitaxel + Carboplatin | Experimental | Drug: Paclitaxel (Chemotherapy), Drug: CarboplatinPaclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle AND Carboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle |
| Pembrolizumab + Paclitaxel + Carboplatin | Experimental | Drug: Pembrolizumab, Drug: Paclitaxel (Chemotherapy), Drug: CarboplatinPembrolizumab 200 mg fixed dose IV once every 3 weeks administered on Day 1 of each Cycle AND Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle AND Carboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Must have histologically confirmed invasive triple negative breast cancer as defined by ER/PR <10% and HER2 negative by ASCO/CAP criteria or disease consistent with TNBC by physician assessment, with confirmation by study PI.
- Must have untreated, non-metastatic (M0), cT1 (T1a-T1c) N0 disease. Biopsies of suspicious lymph nodes to confirm nodal status are required.
- Bilateral or multifocal disease can be included as long as all areas have been biopsied and are consistent with invasive triple negative breast cancer. In the case of bilateral or multifocal disease, the tumor with the most advanced T stage should be used to assess eligibility.
- The patient must be ≥ 18 years of age on day of signing informed consent.
- Male participants must agree to use a contraception as detailed in Appendix A of this protocol during the treatment period and for at least 6 months after the last dose of study treatment and refrain from donating sperm during this period.
Key exclusion criteria (22 listed)
- A WOCBP who has a positive urine pregnancy test within 72 hours prior to randomization (see Appendix A). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. If 72 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative for subject to start receiving study medication.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
- Has received systemic anti-cancer therapy, including investigational agents, prior to randomization.
- If the participant has received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Has received radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis.
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 |
|---|---|---|
| PembrolizumabAlso: KeytrudaPembrolizumab 200 mg fixed dose IV once every 3 weeks | Drug | Pembrolizumab, Pembrolizumab + Paclitaxel + Carboplatin |
| Paclitaxel (Chemotherapy)Also: TaxolPaclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle | Drug | Paclitaxel + Carboplatin, Pembrolizumab + Paclitaxel + Carboplatin |
| CarboplatinAlso: ParaplatinCarboplatin AUC 1.5 IV once per day on Days 1, 8, 15 of each Cycle OR Carboplatin AUC 5 IV once on Day 1 of each Cycle | Drug | Paclitaxel + Carboplatin, Pembrolizumab + Paclitaxel + Carboplatin |
Primary outcome
Rate of Pathologic complete response (pCR)
Time frame: Enrollment to surgery at 12 weeks
To describe rates of pCR in patients with stage I TNBC who receive neoadjuvant therapy with pembrolizumab or carboplatin-paclitaxel or carboplatin-paclitaxel-pembrolizumab. pCR is defined as the absence of residual invasive cancer in the breast and all sampled regional lymph nodes following neoadjuvant therapy. It is assessed by histopathologic examination.
5 secondary outcomes
Residual disease burden
Time frame: Enrollment to surgery at 12 weeks
Rate of treatment discontinuation
Time frame: Enrollment to 6 weeks
Assess 3-year invasive disease-free survival (IDFS)
Time frame: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Treatment-related adverse events
Time frame: Start of study treatment (cycle 1 day 1) until 30 days after the last dose of study treatment.
3-year overall survival (OS)
Time frame: From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months
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 26 Aug 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.
Joshua Gruber, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Paclitaxel (Chemotherapy) and Carboplatin in people with Triple-Negative Breast Cancer (TNBC), run by University of Texas Southwestern Medical Center at 1 site in United States.
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 20 inclusion and 22 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: opening soon, as of the sponsor's last update on 26 Aug 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 United States. 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 Meredith Carter, MS (214-648-7097, Meredith.Carter@UTSouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Pathologic complete response (pCR) (time frame: Enrollment to surgery at 12 weeks). 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 26 Aug 2026; AzTrials last refreshed its copy on 30 Oct 2026.