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Triple-negative Breast CancerPhase 2NeoPACTNCT03639948

Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer

A Phase 2 study testing Carboplatin, Docetaxel and Pembrolizumab in people with Triple-negative Breast Cancer, run by University of Kansas Medical Center at 9 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The standard treatment for women with stage I, II, and III triple-negative breast cancer (TNBC) includes chemotherapy and surgery, with or without radiation therapy. However, because TNBC is usually more aggressive, harder to treat, and more likely to come back, it is associated with poor long-term outcomes (survival… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
Carboplatin, Docetaxel and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
9 sitesUnited States
Study dates
4 Sep 2018to Nov 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Ability of participant to understand this study, and participant willingness to sign a written informed consent for this trial.
  • Histologically confirmed stage I , II or III TNBC (triple-negative breast cancer).
  • No previous definitive ipsilateral breast surgery for the current breast cancer.
  • No previous chemotherapy, endocrine therapy, or radiation therapy with therapeutic intent for this cancer.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function
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  • Adequate cardiac function
  • 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)
  • A WOCBP who agrees to follow contraceptive guidelines.

Who cannot join

  • Current or anticipated use of other investigational agents while participating in this study.
  • Participant has received chemotherapy, radiotherapy, or surgery for the treatment of breast cancer.
  • Participant has metastatic disease.
  • Participant has inflammatory breast cancer.
  • Participants with concomitant or previous malignancies within the last 5 years are excluded from the study.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ (DCIS), carcinoma in situ of the cervix) that have undergone potential curative therapy are not excluded.
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  • History of allergic reactions or hypersensitivity attributed to compounds of similar chemical or biologic composition to agents used in this study.
  • Participant has received prior therapy with an anti-programmed death (PD) -1, anti-PD-ligand (L)-1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory thymus lymphocyte (T-cell) receptor.
  • Subject has received a live vaccine within 30 days prior to the first dose of study drug.
  • Participant 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
  • Participant has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of Pembrolizumab.
  • Has active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has a history of (non-infectious) pneumonitis that required steroids, or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Has a known history of Human Immunodeficiency Virus (HIV).
  • Has a known history of Hepatitis B or known active Hepatitis C virus.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Texas Oncology- Baylor

    Dallas, Texas, 75246

  • The University of Kansas Cancer Center (KUCC)

    Fairway, Kansas, 66205

  • The University of Kansas Cancer Center, West Clinic

    Kansas City, Kansas, 66112

  • The University of Kansas Cancer Center, Westwood Campus

    Kansas City, Kansas, 66205

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66205

  • The University of Kansas Cancer Center, North Clinic

    Kansas City, Missouri, 64154

  • The University of Kansas Cancer Center, Lee's Summit Clinic

    Lee's Summit, Missouri, 64064

  • The University of Kansas Medical Center

    North Kansas City, Missouri, 64116

  • The University of Kansas Cancer Center, Overland Park Clinic

    Overland Park, Kansas, 66210

Other trials in United States

About this study

The standard treatment for women with stage I, II, and III triple-negative breast cancer (TNBC) includes chemotherapy and surgery, with or without radiation therapy. However, because TNBC is usually more aggressive, harder to treat, and more likely to come back, it is associated with poor long-term outcomes (survival rates) when compared to other types of breast cancer. Therefore, researchers are studying how new drugs and treatment combinations can improve the outcome of patients with TNBC. This study will test effectiveness of immune therapy (Pembrolizumab is an "immunotherapy" that is expected to work with the body's immune system to help fight cancer) in combination with chemotherapy given before surgery.

Keywords
Pembrolizumab, Carboplatin, Docetaxel, Pegfilgrastim, 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.

Study groups in NCT03639948
Study groupRoleWhat they receive
Experimental: Carboplatin & Docetaxel plus PembroluzimabExperimentalCarboplatin (Area under the curve [AUC] 6 intravenously [IV]) and Docetaxel (75 milligrams per meter squared [mg/m2], IV) plus Pembrolizumab (200 milligrams [mg], IV) every 21 days for 6 cycles. Pegfilgrastim 6 mg subcutaneous (SC) Day 2 of each cycle.
Receives: Drug: Carboplatin; Drug: Docetaxel; Drug: Pembrolizumab; Drug: Pegfilgrastim

What is being measured

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

  1. Pathological Complete Response (pCR) Rate

    Defined as the percentage of patients with PCR, as evidenced by absence of invasive disease in breast and axillary lymph nodes determined by histopathological examination.

    Measured: Up to 25 weeks

Secondary outcomes (2)

  1. Minimal Residual Disease (MRD) Rate

    Defined as the percentage of patients with MRD, as evidenced by residual cancer burden (RCB) score of 0/1. 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 25 weeks

  2. Percentage of Participants With Event-free Survival (EFS) as Assessed by Kaplan-Meier Method

    Percentage of patients with EFS as assessed by Kaplan-Meier method. EFS is defined as time from diagnosis to first invasive locoregional or distant recurrence, study treatment-related death, or breast cancer-related death

    Measured: Up to 3 years

Timeline

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

  1. First posted21 Aug 2018
  2. Study start4 Sep 2018
  3. Primary completion27 Jan 2022
  4. Study completionNov 2024 (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
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03639948
Sponsor's protocol ID
IIT-2017-NeoPACT
Acronym
NeoPACT
Status last verified
Apr 2024
First submitted
17 Aug 2018
Last updated
11 Apr 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharma P, Stecklein SR, Yoder R, Staley JM, Schwensen K, O'Dea A, Nye L, Satelli D, Crane G, Madan R, O'Neil MF, Wagner J, Larson KE, Balanoff C, Kilgore L, Phadnis MA, Godwin AK, Salgado R, Khan QJ, O'Shaughnessy J. Clinical and Biomarker Findings of Neoadjuvant Pembrolizumab and Carboplatin Plus Docetaxel in Triple-Negative Breast Cancer: NeoPACT Phase 2 Clinical Trial. JAMA Oncol. 2024 Feb 1;10(2):227-235. doi: 10.1001/jamaoncol.2023.5033.

    PubMed 37991778

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carboplatin, Docetaxel and Pembrolizumab in people with Triple-negative Breast Cancer, run by University of Kansas Medical Center at 9 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 10 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 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?

Yes. Results are posted in the registry (first posted 11 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (time frame: Up to 25 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 NCT03639948, which also lists 1 linked publication.

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 11 Apr 2024.

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