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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Triple-negative Breast Cancer
• Intervention / Treatment: Drug: Carboplatin; Drug: Docetaxel; Drug: Pembrolizumab; Drug: Pegfilgrastim

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Fairway, Kansas, United States, 66205
      • The University of Kansas Cancer Center (KUCC)
    • Kansas City, Kansas, United States, 66205
      • The University of Kansas Cancer Center, Westwood Campus
    • Kansas City, Kansas, United States, 66112
      • The University of Kansas Cancer Center, West Clinic
    • Kansas City, Kansas, United States, 66205
      • University of Kansas Cancer Center
    • Overland Park, Kansas, United States, 66210
      • The University of Kansas Cancer Center, Overland Park Clinic
  • Missouri
    • Kansas City, Missouri, United States, 64154
      • The University of Kansas Cancer Center, North Clinic
    • Lee's Summit, Missouri, United States, 64064
      • The University of Kansas Cancer Center, Lee's Summit Clinic
    • North Kansas City, Missouri, United States, 64116
      • The University of Kansas Medical Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology- Baylor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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).
• Has a known history of Hepatitis B or known active Hepatitis C virus.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Carboplatin; Intravenous solution; Drug: Docetaxel; Intravenous solution; Drug: Pembrolizumab; Intravenous solution; Drug: Pegfilgrastim; Injectable product

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 25 weeks
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	Up to 3 years

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Priyanka Sharma, MD, The University of Kansas Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2018
• Primary Completion (Actual): January 27, 2022
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: August 17, 2018
• First Submitted That Met QC Criteria: August 17, 2018
• First Posted (Actual): August 21, 2018

Study Record Updates

• Last Update Posted (Actual): April 11, 2024
• Last Update Submitted That Met QC Criteria: April 5, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Docetaxel; breast cancer; Pembrolizumab; Carboplatin; Pegfilgrastim
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Docetaxel; Carboplatin; Pembrolizumab
• Other Study ID Numbers: IIT-2017-NeoPACT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No