Tailored Neoadjuvant Chemoimmunotherapy for Stage I TNBC

NCT07786428 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STU20261119
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Triple-Negative Breast Cancer (TNBC)

Keywords

Breast; DÉTENTE-1; neoadjuvant chemoimmunotherapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Enrollment to surgery at 12 weeks

Secondary Outcomes (5)

• Residual disease burden

  Enrollment to surgery at 12 weeks

• Rate of treatment discontinuation

  Enrollment to 6 weeks

• Assess 3-year invasive disease-free survival (IDFS)

  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

  Start of study treatment (cycle 1 day 1) until 30 days after the last dose of study treatment.

• 3-year overall survival (OS)

  From date of randomization until the date of death from any cause, whichever came first, assessed up to 36 months

Study Arms (3)

Pembrolizumab

EXPERIMENTAL

Pembrolizumab 200 mg fixed dose IV once every 3 weeks administered on Day 1 of each Cycle

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

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

Drug: Pembrolizumab; Drug: Paclitaxel (Chemotherapy); Drug: Carboplatin

Interventions

Pembrolizumab DRUG

Pembrolizumab 200 mg fixed dose IV once every 3 weeks

Also known as: Keytruda

Pembrolizumab; Pembrolizumab + Paclitaxel + Carboplatin

Paclitaxel (Chemotherapy) DRUG

Paclitaxel 80 mg/m2 IV once per day on Days 1, 8, 15 of each Cycle

Also known as: Taxol

Paclitaxel + Carboplatin; Pembrolizumab + Paclitaxel + Carboplatin

Carboplatin DRUG

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

Also known as: Paraplatin

Paclitaxel + Carboplatin; Pembrolizumab + Paclitaxel + Carboplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

pembrolizumab; Paclitaxel; Drug Therapy; Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Therapeutics; Coordination Complexes

Study Officials

• Joshua Gruber, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Meredith Carter, MS

CONTACT

214-648-7097; Meredith.Carter@UTSouthwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 26, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 31, 2029
• Study Completion (Estimated): October 31, 2030
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)