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

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ClinicalTrials.gov Identifier: NCT03639948
Recruitment Status : Recruiting
First Posted : August 21, 2018
Last Update Posted : September 5, 2018
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Triple-negative Breast Cancer Drug: Carboplatin Drug: Docetaxel Drug: Pembrolizumab Drug: Pegfilgrastim Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Pathological complete response (pCR) rate [ Time Frame: Up to 25 weeks ]
    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 :
  1. Minimal residual disease (MRD) rate [ Time Frame: Up to 25 weeks ]
    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).

  2. Recurrence-free survival (RFS) [ Time Frame: Up to 3 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female subjects
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03639948


Contacts
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Contact: Kerry Hepler 913-945-7552 ctnursenav@kumc.edu

Locations
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United States, Kansas
University of Kansas Cancer Center Recruiting
Kansas City, Kansas, United States, 66205
Contact: Kerry Hepler       ctnursenav@kumc.edu   
Principal Investigator: Priyanka Sharma, MD         
Sponsors and Collaborators
University of Kansas Medical Center
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Priyanka Sharma, MD The University of Kansas Cancer Center

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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT03639948     History of Changes
Other Study ID Numbers: IIT-2017-NeoPACT
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by University of Kansas Medical Center:
Pembrolizumab
Carboplatin
Docetaxel
Pegfilgrastim
breast cancer

Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Carboplatin
Docetaxel
Pembrolizumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological