Stage 1 cT1b-T1cN0M0Phase 2NCT06318897

Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer

A Phase 2 study testing Carboplatin, Paclitaxel and Pembrolizumab in people with Stage 1 cT1b-T1cN0M0 and Triple Negative Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stage 1 cT1b-T1cN0M0, Triple Negative Breast Cancer
What is being tested?: Carboplatin, Paclitaxel and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: 29 May 2024to 30 Sep 2027
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

Participants are eligible to be included in the study only if all of the following criteria apply:
Participants must have histologically confirmed ER negative, PR negative and HER2-negative (TNBC) defined as ER<10%, PR<10%, and HER2 negative (per 2018 ASCO CAP guidelines). All pathology will be confirmed at the MD Anderson Houston Campus. Participants with tumors designated as HER2 equivocal (per ASCO CAP guidelines) are eligible if in view of treating physician patient is not considered a candidate for HER2-targeted therapy. Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-9% by immunohistochemistry, are eligible if the treating physician considers the participants not eligible for adjuvant endocrine therapy.
AJCC 8 anatomic tumor Stage 1 T1b-T1c, N0, M0. All participants with clinically suspicious nodes must undergo core or fine needle biopsy per standard clinical practice to pathologically assess at least 1 suspicious index node. Participants with suspicious nodes that are biopsy negative will be eligible.
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage 1 T1b-T1cN0M0 TNBC will be enrolled in this study.
Male participants: A male participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab and/or any active comparator/combination) plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.
Female participants: A female participant is eligible to participate if she is not pregnant (see Appendix 2), not breastfeeding, and at least one of the following conditions applies:

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Not a woman of childbearing potential (WOCBP) as defined in Appendix 2 OR
A WOCBP who agrees to follow the contraceptive guidance in Appendix 2 during the treatment period and for at least 120 days (corresponding to time needed to eliminate any study treatment(s) (pembrolizumab and/or any active comparator/combination) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity after the last dose of study treatment.
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
The participant provides written informed consent for the trial.
Archival tumor tissue sample or newly obtained [core, incisional or excisional] biopsy of a tumor lesion not previously irradiated has been provided. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 (appendix 3). Evaluation of ECOG is to be performed within 7 days prior to the first dose of study intervention.
Have adequate organ function as defined in the following table (Table 3). Specimens must be collected within 10 days prior to the start of study intervention.
Non-English speaking participant can enroll in the study as long as they speak a language for which interpretation can be provided by a licensed interpreter either in person or virtually.
Criteria for known HIV positive participants.
Participants with HIV are eligible if they have well-controlled HIV with negative viral load on ART and must not have had any AIDS-defining opportunistic infections within the past 12 months from initiation of C1D1 study treatment.
HIV screening tests are not required unless:
Known history of HIV ii. As mandated by local health authority
Criteria for known Hepatitis B and C positive participants Hepatitis B and C screening tests are not required unless:
Known history of HBV or HCV infection
As mandated by local health authority 13.1 Hepatitis B positive Participants
Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization.
Participants should remain on anti-viral therapy throughout study intervention and follow local guidelines for HBV anti-viral therapy post completion of study intervention. 13.2 Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening.
Participants must have completed curative anti-viral therapy at least 4 weeks prior to randomization.
Table 3 Adequate Organ Function Laboratory Values System Laboratory Value Hematological Absolute neutrophil count (ANC) = ≥1500/µL Platelets = ≥100 000/µL Hemoglobin = ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculatedb creatinine clearance (GFR can also be used in place of creatinine or CrCl) = ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN Hepatic Total bilirubin = ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN AST (SGOT) and ALT (SGPT) = ≤2.5 × ULN (≤5 × ULN for participants with liver metastases) Coagulation International normalized ratio (INR) OR prothrombin time (PT) Activated partial thromboplastin time (aPTT) = ≤1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal. a Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks. b Creatinine clearance (CrCl) should be calculated per institutional standard. Note: This table includes eligibility-defining laboratory value requirements for treatment; laboratory value requirements should be adapted according to local regulations and guidelines for the administration of specific chemotherapies.

Who cannot join

Participants are excluded from the study if any of the following criteria apply:
Stage 2, 3 or 4 Triple negative breast cancer
Hormone Receptor positive and/or Human Epidermal Growth factor 2 (HER 2) positive breast cancer
A WOCBP who has a positive urine pregnancy test within 72 hours prior to dose of study drug (see Appendix 2). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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 (eg, CTLA-4, OX-40, CD137).
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to allocation of therapy.

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Has received prior radiotherapy within 2 weeks of start of study intervention or radiation-related toxicities requiring corticosteroids. Note: Two weeks or fewer of palliative radiotherapy for non-CNS disease, with a 1-week washout, is permitted.
Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
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.
Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.
Has known active CNS metastases and/or carcinomatous meningitis.
Has severe hypersensitivity (≥Grade 3) to any of the components or any of its excipients used in the study treatments.
Has active autoimmune disease that has required systemic treatment in the past 2 years except replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid)
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Has an active infection requiring systemic therapy for >14 days from initiation of C1D1 study treatment.
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection. Note: Hepatitis B and C screening tests are not required unless:
Known history of HBV and HCV infection
As mandated by local health authority
Has not adequately recovered from major surgery or has ongoing surgical complications.
Has a history or current evidence of any condition, therapy, or laboratory abnormality or other circumstance that might confound the results of the study, interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.
Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
Is pregnant or breastfeeding or 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 had an allogenic tissue/solid organ transplant.
Participants with the following contraindications to doxorubicin therapy: recent myocardial infarction; severe myocardial insufficiency; severe arrhythmias; previous treatment with complete cumulative doses of doxorubicin, daunorubicin, idarubicin, and/or other anthracyclines and anthracenedione.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Oluchi Oke, MD contact

(832) 729-8362

oukaegbu@mdanderson.org

United States1 site, 1 recruiting

MD Anderson Cancer Center
Houston, Texas, 77030
Oluchi Oke, MD, 832-729-8362, oukaegbu@mdanderson.org
Oluchi Oke, MD
Recruiting

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About this study

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.

Read the detailed description

Primary Objective To estimate the rate of pCR in patients with cT1b and T1cN0M0 TNBC after neoadjuvant therapy with 4 cycles of Pembrolizumab + Carboplatin + Paclitaxel.

Secondary Objective To assess the safety and toxicity profile of pembrolizumab plus chemotherapy in participants receiving an anthracycline-de-escalated regimen of carboplatin, paclitaxel and pembrolizumab by recording the incidence of treatment emergent adverse events.

Exploratory Objectives

To estimate the invasive disease-free survival (iDFS), and overall survival (OS) in participants with cT1b-T1cN0 TNBC that receive neoadjuvant pembrolizumab plus chemotherapy in the setting of an anthracycline de-escalation study.
To explore if there is a molecular signature associated with response or lack of response to therapy.
To evaluate patient reported outcomes of participants receiving this de-escalated regimen.

Conditions: Stage 1 cT1b-T1cN0M0, Triple Negative Breast Cancer
Being tested: Carboplatin, Paclitaxel, Pembrolizumab, Doxorubicin, Cyclophosphamide
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.

CarboplatinDrug
Also called Paraplatin®
Given by IV
PaclitaxelDrug
Also called PACLITAXEL PROTEIN BOUND
Given by IV
PembrolizumabDrug
Also called KEYTRUDA®
Given by IV
DoxorubicinDrug
Also called Doxorubicin Hydrochloride, Adriamycin PFS®, Adriamycin RDF™, Adriamycin®
Given by IV
CyclophosphamideDrug
Also called Cytoxan®, Neosar®
Given by IV

Study groups in NCT06318897
Study group	Role	What they receive
Pathologic Complete Response	Experimental	If a participant's tissue shows a pathological complete response to treatment, participants will receive up to 13 cycles of pembrolizumab alone. Pathological complete response means that the study team cannot find any evidence of cancer in the breast or lymph node tissue sample that was removed during the participants surgery, after the participant completes the 4 cycles of carboplatin, pembrolizumab and paclitaxel. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab
Non-Pathologic Complete Response	Experimental	If a participant's tissue does not show a pathological complete response, the participant will receive 4 cycles of pembrolizumab plus 2 other drugs (doxorubicin and cyclophosphamide), followed by 9 cycles of pembrolizumab alone. Receives: Drug: Carboplatin; Drug: Paclitaxel; Drug: Pembrolizumab; Drug: Doxorubicin; Drug: Cyclophosphamide

What is being measured

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

Safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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.

29 May 202430 Sep 2027

First posted19 Mar 2024
Study start29 May 2024
Primary completion30 Sep 2027 (estimated)
Study completion30 Sep 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Stage 1 cT1b-T1cN0M0Studies of the same condition, open and under way.
More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
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: Single group
Masking: None (open label)
Enrolment: 28 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06318897
Sponsor's protocol ID: 2023-0645
Other IDs: NCI-2024-02384
Status last verified: Mar 2026
First submitted: 13 Mar 2024
Last updated: 4 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT06318897
Acronym / sponsor ID: 2023-0645
Conditions: Stage 1 cT1b-T1cN0M0, Triple Negative Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 28 participants (estimated)
Lead sponsor: M.D. Anderson Cancer CenterUniversity, hospital or other
Study start: 29 May 2024 (actual)
Primary completion: 30 Sep 2027 (estimated)
Study completion: 30 Sep 2027 (estimated)
First posted: 19 Mar 2024 (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.

To look at the effectiveness of the combination of pembrolizumab, carboplatin, and paclitaxel in participants with stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer.

Detailed description

Primary Objective To estimate the rate of pCR in patients with cT1b and T1cN0M0 TNBC after neoadjuvant therapy with 4 cycles of Pembrolizumab + Carboplatin + Paclitaxel.

Exploratory Objectives

To estimate the invasive disease-free survival (iDFS), and overall survival (OS) in participants with cT1b-T1cN0 TNBC that receive neoadjuvant pembrolizumab plus chemotherapy in the setting of an anthracycline de-escalation study.
To explore if there is a molecular signature associated with response or lack of response to therapy.
To evaluate patient reported outcomes of participants receiving this de-escalated regimen.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Pathologic Complete Response	Experimental	Drug: Carboplatin, Drug: Paclitaxel, Drug: PembrolizumabIf a participant's tissue shows a pathological complete response to treatment, participants will receive up to 13 cycles of pembrolizumab alone. Pathological complete response means that the study team cannot find any evidence of cancer in the breast or lymph node tissue sample that was removed during the participants surgery, after the participant completes the 4 cycles of carboplatin, pembrolizumab and paclitaxel.
Non-Pathologic Complete Response	Experimental	Drug: Carboplatin, Drug: Paclitaxel, Drug: Pembrolizumab, Drug: Doxorubicin, Drug: CyclophosphamideIf a participant's tissue does not show a pathological complete response, the participant will receive 4 cycles of pembrolizumab plus 2 other drugs (doxorubicin and cyclophosphamide), followed by 9 cycles of pembrolizumab alone.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (25 listed)

Participants are eligible to be included in the study only if all of the following criteria apply:
Participants must have histologically confirmed ER negative, PR negative and HER2-negative (TNBC) defined as ER<10%, PR<10%, and HER2 negative (per 2018 ASCO CAP guidelines). All pathology will be confirmed at the MD Anderson Houston Campus. Participants with tumors designated as HER2 equivocal (per ASCO CAP guidelines) are eligible if in view of treating physician patient is not considered a candidate for HER2-targeted therapy. Participants with weakly ER or PR positive disease, defined as ER and/or PR between 1-9% by immunohistochemistry, are eligible if the treating physician considers the participants not eligible for adjuvant endocrine therapy.
AJCC 8 anatomic tumor Stage 1 T1b-T1c, N0, M0. All participants with clinically suspicious nodes must undergo core or fine needle biopsy per standard clinical practice to pathologically assess at least 1 suspicious index node. Participants with suspicious nodes that are biopsy negative will be eligible.
Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of Stage 1 T1b-T1cN0M0 TNBC will be enrolled in this study.
Male participants: A male participant must agree to use a contraception as detailed in Appendix 2 of this protocol during the treatment period and for at least 120 days, corresponding to time needed to eliminate any study treatment(s) (e.g. 5 terminal half-lives for pembrolizumab and/or any active comparator/combination) plus an additional 90 days (a spermatogenesis cycle) for study treatments with evidence of genotoxicity at any dose after the last dose of study treatment and refrain from donating sperm during this period.

Key exclusion criteria (25 listed)

Stage 2, 3 or 4 Triple negative breast cancer
Hormone Receptor positive and/or Human Epidermal Growth factor 2 (HER 2) positive breast cancer
A WOCBP who has a positive urine pregnancy test within 72 hours prior to dose of study drug (see Appendix 2). If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
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 (eg, CTLA-4, OX-40, CD137).
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks to allocation of therapy.

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
CarboplatinAlso: Paraplatin®Given by IV	Drug	Non-Pathologic Complete Response, Pathologic Complete Response
PaclitaxelAlso: PACLITAXEL PROTEIN BOUNDGiven by IV	Drug	Non-Pathologic Complete Response, Pathologic Complete Response
PembrolizumabAlso: KEYTRUDA®Given by IV	Drug	Non-Pathologic Complete Response, Pathologic Complete Response
DoxorubicinAlso: Doxorubicin Hydrochloride, Adriamycin PFS®, Adriamycin RDF™, Adriamycin®Given by IV	Drug	Non-Pathologic Complete Response
CyclophosphamideAlso: Cytoxan®, Neosar®Given by IV	Drug	Non-Pathologic Complete Response

Primary outcome

Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

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 4 Mar 2026.
MD Anderson Cancer CenterLink provided by the sponsor.

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.

Oluchi Oke, MD contact

(832) 729-8362

oukaegbu@mdanderson.org

Oluchi Oke, MD principal investigator

M.D. Anderson Cancer 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 Carboplatin, Paclitaxel and Pembrolizumab in people with Stage 1 cT1b-T1cN0M0 and Triple Negative Breast Cancer, run by M.D. Anderson Cancer 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 25 inclusion and 25 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 4 Mar 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 Oluchi Oke, MD ((832) 729-8362, oukaegbu@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). 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 NCT06318897.

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 4 Mar 2026.