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Triple Negative Breast CancerPhase 2NCT06407310

Neoadjuvant Pembrolizumab, Carboplatin and Paclitaxel in Triple-negative Breast Cancer

A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Triple Negative Breast Cancer, run by Tel Aviv Medical Center.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate of a non-anthracycline-based chemo-immunotherapy regimen. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
Pembrolizumab, Carboplatin and Paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
No sites listed yet
Study dates
1 Jul 2024to 1 Dec 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

  • Male/female participants who are at least 18 years of age on the day of signing informed consent with a histologically confirmed diagnosis of stage I or II TNBC.
  • Tumor size of above 1 cm.
  • The patient is willing to provide tissue from newly obtained core biopsies.
  • Male participants:
  • A male participant must agree to use contraception as detailed in Appendix 3 of this protocol during the treatment period and for at least 200 days after the last dose of study treatment and refrain from donating sperm during this period.
  • Female participants:
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  • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
  • Not a woman of childbearing potential (WOCBP). OR
  • A WOCBP who agrees to follow the contraceptive during the treatment period and for at least 180 days after the last dose of chemotherapy.
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days before the first dose of study intervention.
  • Have adequate organ function as defined in the following table (Table 4). Specimens must be collected within 10 days before the start of the study intervention.
  • Criteria for known Hepatitis B and C positive subjects
  • Hepatitis B (HBV) and C (HCV) screening tests are not required unless:
  • Known history of HBV or HCV infection
  • As mandated by the local health authority
  • 10.1 Hepatitis B positive subjects:
  • Participants who are HBsAg positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have an undetectable HBV viral load before randomization.
  • Participants should remain on anti-viral therapy throughout the study intervention and follow local guidelines for HBV anti-viral therapy post-completion of the study intervention.
  • 10.2 Participants with a history of HCV infection are eligible if the HCV viral load is undetectable at screening.
  • Participants must have completed curative anti-viral therapy at least 4 weeks before randomization.

Who cannot join

  • A WOCBP who has a positive urine pregnancy test within 72 hours prior of the first treatment dose (. 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-Programmed cell death-ligand-1 (PD-L1), anti-PD-1, or anti-PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, cytotoxic T-lymphocyte associated protein 4 (CTLA-4), OX 40, CD137).
  • Has received prior systemic anti-cancer therapy, including investigational agents, within 24 months of screening.
  • Has received prior radiotherapy within 24 months of screening.
  • 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.
  • Note: please refer to Section 5.5.2 for information on coronavirus disease 2019 (COVID-19) vaccines
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  • Has received an investigational agent or has used an investigational device within 4 weeks before 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 before the first dose of the 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 severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years except for 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.
  • Has a known history of Human Immunodeficiency Virus (HIV) infection. Note: No HIV testing is required unless mandated by local health authorities.
  • 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 the 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, 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 or 180 after the last dose of chemotherapy.
  • Has had an allogeneic tissue/solid organ transplant.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Yasmin Leshem, MD, P.hD contact

+972-3-6972061

yasminle@tlvmc.gov.il

About this study

Official title: Phase II Open-label, Single-arm Trial of Neoadjuvant Pembrolizumab With Carboplatin and Paclitaxel in Triple-negative Breast Cancer

This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting.

Read the detailed description

The cure rate of stage I and II triple-negative breast cancer treated with anthracycline-based chemotherapy is high but comes at the price of substantial toxicity. This is a phase II, single-centered, open-label, single-armed study in patients with early triple-negative breast cancer that will evaluate the pathological complete response (pCR) rate and immune effects of a non-anthracycline-based chemo-immunotherapy regimen. The trial includes a lead-in cycle of pembrolizumab, then a combination of paclitaxel, carboplatin, and pembrolizumab in the neoadjuvant setting.

Keywords
Immunotherapy, Pembrolizumab, Breast cancer, Triple-negative breast cancer
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.

  • PembrolizumabDrug

    I.V Pembrolizumab (keytruda) 200 mg every 3 weeks for 6 cycles

  • CarboplatinDrug

    I.V Carboplatin at AUC 1.5 weekly for a total of 12 weeks.

  • PaclitaxelDrug

    I.V Paclitaxel at 80 mg/m2 weekly for a total of 12 weeks.

Study groups in NCT06407310
Study groupRoleWhat they receive
neoadjuvant pembrolizumab with carboplatin and paclitaxel in triple-negative breast cancerExperimental6 cycles of Pembrolizumab (Keytruda) at a dose of 200 mg given every 3 weeks for 6 cycles. The first cycle of pembrolizumab is given as a lead-in without carboplatin and paclitaxel. Carboplatin area under the curve (AUC) 1.5 and Paclitaxel 80 mg/m2, starting with the second pembrolizumab cycle, will be given weekly for 12 weeks.
Receives: Drug: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel

What is being measured

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

  1. Pathological complete response rate (pCR= ypT0/Tis ypN0)

    The number of patients with pathological complete response (pCR) out of the total number of trial participants using a definition of ypT0/Tis ypN0 after treatment with neoadjuvant pembrolizumab, paclitaxel and carboplatin (PCb).

    Measured: 3 years

  2. Molecular dynamics of cells in the tumor microenvironment (TME)

    The molecular state of cells in the TME will be measured at a single-cell level using single-cell RNA sequencing (scRNA-seq) before and after one dose of pembrolizumab.

    Measured: 3 years

Secondary outcomes (2)

  1. 3-year overall survival (OS) rate

    The number of patients that are alive three years after entering the trial out of the total number of trial participants.

    Measured: 5 years

  2. 3-year event-free survival (EFS) rate

    The number of patients without disease recurrence three years after entering the trial out of the total number of trial participants.

    Measured: 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 May 2024
  2. Study start1 Jul 2024 (estimated)
  3. Primary completion1 Apr 2027 (estimated)
  4. Study completion1 Dec 2027 (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
Not applicable
Intervention model
Single group
Model description
Single Group Assignment
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06407310
Sponsor's protocol ID
0617-22 TLV
Status last verified
May 2024
First submitted
4 Mar 2024
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Carboplatin and Paclitaxel in people with Triple Negative Breast Cancer, run by Tel Aviv Medical Center.

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 21 inclusion and 23 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 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

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 Yasmin Leshem, MD, P.hD (+972-3-6972061, yasminle@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response rate (pCR= ypT0/Tis ypN0) (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT06407310.

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 9 May 2024.

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