AzTrials
AzTrials

Triple Negative Breast CancerPhase 2NeoTRACTNCT05645380

Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC

A Phase 2 study testing Carboplatin, Docetaxel and Doxorubicin in people with Triple Negative Breast Cancer and Breast Cancer, run by University of Kansas Medical Center at 7 sites in United States.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer. Read more about this study

Who is it for?
Ages 18 to 120 years, women only
Conditions the study is for
Triple Negative Breast Cancer, Breast Cancer
What is being tested?
Carboplatin, Docetaxel and Doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
139 participants
Where
7 sitesUnited States
Study dates
5 Dec 2022to Dec 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 to 120 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Female subjects 18 years of age or older
  • Histologically confirmed cT1c-T3N0, cT1-T3N1-N2, cTxN1-2 TNBC
  • The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC
  • The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines
  • No previous ipsilateral breast surgery for the current breast cancer
Show all 17Show fewer
  • No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer
  • ECOG Performance Status 0 - 1 documented within 21 days prior to the start of study treatment
  • Breast and axillary imaging (including ultrasound and MRI) within 42 days (6 weeks) prior to treatment initiation
  • Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic confirmation of disease status with image-guided biopsy or fine needle aspiration
  • Archival breast tumor tissue has been obtained or has been requested for use
  • No clinically apparent metastatic disease. Staging to rule out metastatic disease is suggested for patients with clinical TNM stage III disease
  • Subjects with bilateral synchronous TNBC are eligible if they meet other eligibility criteria
  • No baseline neuropathy greater than grade 2
  • Patients are not pregnant, not breastfeeding, and either not a woman of childbearing potential or agrees to follow specific contraceptive guidelines during the treatment period and for at least 120 days after the last dose of study treatment
  • Adequate hematologic, hepatic, and renal function assessed ≤ 21 days from treatment initiation
  • Only if assigned to Regimen C, LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care (assessed within 120 days prior to receiving doxorubicin + cyclophosphamide)

Who cannot join

  • Current or anticipated use of other investigational agents while participating in this study
  • Subject has previously received chemotherapy, immunotherapy, endocrine therapy, radiotherapy, or surgery for this breast cancer
  • Subject has clinically or radiographically detected metastatic disease
  • Subject has inflammatory breast cancer
  • Subject has a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the treatment regimen. Note: Patients with squamous cell or basal cell carcinoma of the skin, ductal carcinoma in situ (DCIS) of the breast, or carcinoma in situ (CIS) of the uterine cervix who have undergone definitive therapy are not excluded from participation
  • History of allergic reactions attributed to doxorubicin, cyclophosphamide, carboplatin, or docetaxel
Show all 22Show fewer
  • History of severe (≥ grade 3) hypersensitivity to pembrolizumab or any of its excipients
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 inhibitor or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA4, OX40, CD137)
  • If participant has received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
  • Subject has received a live vaccine within 30 days prior to treatment initiation
  • Subject is currently receiving treatment or has received treatment with an investigational agent within four weeks prior to treatment initiation, or has used an investigational device within four weeks prior to treatment initiation
  • Has a diagnosis of immunodeficiency or is receiving chronic steroid therapy (in doses exceeding 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of pembrolizumab
  • Active autoimmune disease that has required systemic treatment (e.g., disease-modifying agents, corticosteroids, immunosuppressive drugs) in the past two years. Note: Patients using replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid therapy) are eligible
  • Currently has or has history of (within the past one year) non-infectious pneumonitis requiring steroids
  • Active infection requiring systemic therapy
  • Known history of human immunodeficiency virus (HIV) infection
  • Active hepatitis B (defined as HBsAg reactive) or hepatitis C (detectable HCV RNA)
  • History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of this study, interfere with the subject's participation for the full duration of the study, or it is not in the best interest of the subject to participate, in the opinion of the treating investigator
  • Subject has known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the study
  • Subject is pregnant or breastfeeding or expecting to conceive within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment
  • Inadequate hematologic, renal, hepatic, or cardiac function.
  • Myocardial infarction, unstable angina pectoris, an arterial thrombotic event, stroke, or transient ischemic attack within the past 12 months, uncontrolled hypertension (systolic BP > 160 mmHg, diastolic BP > 90 mmHg), uncontrolled or symptomatic arrhythmia, or greater than grade 2 peripheral vascular disease

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • The University of Kansas Cancer Center - Clinical Research Center

    Fairway, Kansas, 66205

  • The University of Kansas Cancer Center - Main Hospital

    Kansas City, Kansas, 66160

  • The University of Kansas Cancer Center - Westwood

    Kansas City, Kansas, 66205

  • The University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • The University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • University of Kansas Cancer Center at North Kansas City Hospital

    North Kansas City, Missouri, 64116

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

Other trials in United States

About this study

This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.

Read the detailed description

Triple negative breast cancers (TNBC) with enrichment of immune system cells in and around the tumor are more sensitive to chemoimmunotherapy and have better prognosis. Imaging is often used during the course of neoadjuvant chemoimmunotherapy to monitor how the disease is responding to treatment, and disappearance of a patient's tumor on imaging after chemoimmunotherapy usually means that the tumor will have completely disappeared when the patient goes for surgery. This study will test whether the presence of immune system cells in and around the tumor and the response of the tumor on MRI can be used to personalize the type and amount of neoadjuvant chemoimmunotherapy for patients with TNBC.

Keywords
Tumor infiltrating lymphocytes, Neoadjuvant chemotherapy, Neoadjuvant immunotherapy
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

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

Study groups in NCT05645380
Study groupRoleWhat they receive
High sTILs (≥30%)Active comparatorCarboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles.
Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Pembrolizumab
Intermediate sTILs (5-29%)Active comparatorCarboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for six cycles.
Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Pembrolizumab
Low sTILs (<5%)Active comparatorCarboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles followed by Doxorubicin (60 mg/m2) + Cyclophosphamide (600 mg/m2) + Pembrolizumab (200 mg) every 14 or 21 days for four cycles.
Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Doxorubicin; Drug: Cyclophosphamide; Drug: Pembrolizumab

What is being measured

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

  1. Pathological complete response (pCR) rate in high sTIL cohort with radiographic complete response

    Defined as percentage of participants who achieve pathological complete response in the breast and axilla. Pathological complete response is defined as no evidence of invasive disease in the breast (residual DCIS permitted) and axilla at the time of pathology review.

    Measured: Up to 26 weeks

Secondary outcomes (4)

  1. Residual cancer burden (RCB) 0+1 rate in high sTIL cohort with radiographic complete response

    Defined as summed percentage of participants with RCB=0 and RCB=1 in the breast and axilla. Residual cancer burden score for each patient is calculated using surgical pathology parameters using an online tool (http://www3.mdanderson.org/app/medcalc/index.cfm?pagename=jsconvert3).

    Measured: Up to 26 weeks

  2. pCR and RCB 0+1 in intermediate sTIL cohort

    Percentage of participants with intermediate sTILs who achieve pCR (RCB=0) and RCB=0+RCB=1.

    Measured: Up to 26 weeks

  3. pCR and RCB 0+1 in low sTIL cohort

    Percentage of participants with low sTILs who achieve pCR (RCB=0) and RCB=0+RCB=1.

    Measured: Up to 32 weeks

  4. Recurrence-free, event-free, and overall survival

    Recurrence-free survival is defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause., event-free survival is defined as time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to breast cancer related death, and overall survival is defined as time from diagnosis to death from any cause.

    Measured: Up to 5 years

Timeline

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

  1. First posted9 Dec 2022
  2. Study start5 Dec 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
139 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05645380
Sponsor's protocol ID
STUDY00149312
Acronym
NeoTRACT
Status last verified
Apr 2026
First submitted
1 Dec 2022
Last updated
28 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Docetaxel and Doxorubicin in people with Triple Negative Breast Cancer and Breast Cancer, run by University of Kansas Medical Center at 7 sites 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 17 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: under way, not looking for participants, as of the sponsor's last update on 28 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 7 sites 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?

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?

Pathological complete response (pCR) rate in high sTIL cohort with radiographic complete response (time frame: Up to 26 weeks). 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 NCT05645380.

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 28 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in