Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer
NCT ID: NCT03639948
Last Updated: 2024-04-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
120 participants
INTERVENTIONAL
2018-09-04
2024-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer
NCT02413320
Neoadjuvant Treatment of Triple Negative Breast Cancer Patients With Docetaxel and Carboplatin to Assess Anti-tumor Activity
NCT02124902
Neoadjuvant Carbo/Paclitaxel Followed by Doxorubicin/Cyclophosphamide in Breast Cancer
NCT03301350
Pegylated Liposomal Doxorubicin Hydrochloride and Carboplatin Followed by Surgery and Paclitaxel in Treating Patients With Triple Negative Stage II-III Breast Cancer
NCT02315196
Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
NCT02883062
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental: Carboplatin & Docetaxel plus Pembroluzimab
Carboplatin (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.
Carboplatin
Intravenous solution
Docetaxel
Intravenous solution
Pembrolizumab
Intravenous solution
Pegfilgrastim
Injectable product
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Carboplatin
Intravenous solution
Docetaxel
Intravenous solution
Pembrolizumab
Intravenous solution
Pegfilgrastim
Injectable product
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
70 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Sharp & Dohme LLC
INDUSTRY
University of Kansas Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Priyanka Sharma, MD
Role: PRINCIPAL_INVESTIGATOR
The University of Kansas Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, United States
The University of Kansas Cancer Center, West Clinic
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States
University of Kansas Cancer Center
Kansas City, Kansas, United States
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, United States
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, United States
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, United States
The University of Kansas Medical Center
North Kansas City, Missouri, United States
Texas Oncology- Baylor
Dallas, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIT-2017-NeoPACT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.