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

Primary Purpose

Triple-negative Breast Cancer

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Docetaxel
Pembrolizumab
Pegfilgrastim
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple-negative Breast Cancer focused on measuring Pembrolizumab, Carboplatin, Docetaxel, Pegfilgrastim, breast cancer

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Kansas Cancer Center (KUCC)
  • The University of Kansas Cancer Center, West Clinic
  • The University of Kansas Cancer Center, Westwood Campus
  • University of Kansas Cancer Center
  • The University of Kansas Cancer Center, Overland Park Clinic
  • The University of Kansas Cancer Center, North Clinic
  • The University of Kansas Cancer Center, Lee's Summit Clinic
  • The University of Kansas Medical Center
  • Texas Oncology- Baylor

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental: Carboplatin & Docetaxel plus Pembroluzimab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
Recurrence-free survival (RFS)
Defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause.

Full Information

First Posted
August 17, 2018
Last Updated
June 6, 2022
Sponsor
University of Kansas Medical Center
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03639948
Brief Title
Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer
Acronym
NeoPACT
Official Title
Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 4, 2018 (Actual)
Primary Completion Date
May 15, 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple-negative Breast Cancer
Keywords
Pembrolizumab, Carboplatin, Docetaxel, Pegfilgrastim, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
121 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental: Carboplatin & Docetaxel plus Pembroluzimab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Intravenous solution
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
Intravenous solution
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
Intravenous solution
Intervention Type
Drug
Intervention Name(s)
Pegfilgrastim
Intervention Description
Injectable product
Primary Outcome Measure Information:
Title
Pathological complete response (pCR) rate
Description
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.
Time Frame
Up to 25 weeks
Secondary Outcome Measure Information:
Title
Minimal residual disease (MRD) rate
Description
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).
Time Frame
Up to 25 weeks
Title
Recurrence-free survival (RFS)
Description
Defined as the time from diagnosis to first recurrence (invasive ipsilateral breast, invasive local/regional, or distant), or to death as a result of any cause.
Time Frame
Up to 3 years

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female subjects
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Priyanka Sharma, MD
Organizational Affiliation
The University of Kansas Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Kansas Cancer Center (KUCC)
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Cancer Center, West Clinic
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
The University of Kansas Cancer Center, Westwood Campus
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
The University of Kansas Cancer Center, Overland Park Clinic
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
The University of Kansas Cancer Center, North Clinic
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
The University of Kansas Cancer Center, Lee's Summit Clinic
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
The University of Kansas Medical Center
City
North Kansas City
State/Province
Missouri
ZIP/Postal Code
64116
Country
United States
Facility Name
Texas Oncology- Baylor
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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