Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer
NeoPACT
1 other identifier
interventional
120
1 country
9
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2018
Longer than P75 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
September 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2022
CompletedResults Posted
Study results publicly available
April 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedApril 11, 2024
April 1, 2024
3.4 years
August 17, 2018
February 9, 2024
April 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Up to 25 weeks
Secondary Outcomes (2)
Minimal Residual Disease (MRD) Rate
Up to 25 weeks
Percentage of Participants With Event-free Survival (EFS) as Assessed by Kaplan-Meier Method
Up to 3 years
Study Arms (1)
Experimental: Carboplatin & Docetaxel plus Pembroluzimab
EXPERIMENTALCarboplatin (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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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.
- 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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansas Medical Centerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (9)
The University of Kansas Cancer Center (KUCC)
Fairway, Kansas, 66205, United States
The University of Kansas Cancer Center, West Clinic
Kansas City, Kansas, 66112, United States
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, 66205, United States
University of Kansas Cancer Center
Kansas City, Kansas, 66205, United States
The University of Kansas Cancer Center, Overland Park Clinic
Overland Park, Kansas, 66210, United States
The University of Kansas Cancer Center, North Clinic
Kansas City, Missouri, 64154, United States
The University of Kansas Cancer Center, Lee's Summit Clinic
Lee's Summit, Missouri, 64064, United States
The University of Kansas Medical Center
North Kansas City, Missouri, 64116, United States
Texas Oncology- Baylor
Dallas, Texas, 75246, United States
Related Publications (1)
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.
PMID: 37991778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Priyanka Sharma
- Organization
- University of Kansas Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Priyanka Sharma, MD
The University of Kansas Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2018
First Posted
August 21, 2018
Study Start
September 4, 2018
Primary Completion
January 27, 2022
Study Completion
November 1, 2024
Last Updated
April 11, 2024
Results First Posted
April 11, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share