Clinical Trials /

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

NCT03639948

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer
  • Official Title: Neoadjuvant Phase II Study of Pembrolizumab And Carboplatin Plus Docetaxel in Triple Negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: IIT-2017-NeoPACT
  • NCT ID: NCT03639948

Conditions

  • Triple-negative Breast Cancer

Interventions

DrugSynonymsArms
CarboplatinExperimental: Carboplatin & Docetaxel plus Pembroluzimab
DocetaxelExperimental: Carboplatin & Docetaxel plus Pembroluzimab
PembrolizumabExperimental: Carboplatin & Docetaxel plus Pembroluzimab
PegfilgrastimExperimental: Carboplatin & Docetaxel plus Pembroluzimab

Purpose

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 Arms

NameTypeDescriptionInterventions
Experimental: Carboplatin & Docetaxel plus PembroluzimabExperimentalCarboplatin (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
  • Docetaxel
  • Pembrolizumab
  • Pegfilgrastim

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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Pathological complete response (pCR) rate
Time Frame:Up to 25 weeks
Safety Issue:
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.

Secondary Outcome Measures

Measure:Minimal residual disease (MRD) rate
Time Frame:Up to 25 weeks
Safety Issue:
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).
Measure:Recurrence-free survival (RFS)
Time Frame:Up to 3 years
Safety Issue:
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.

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:University of Kansas Medical Center

Trial Keywords

  • Pembrolizumab
  • Carboplatin
  • Docetaxel
  • Pegfilgrastim
  • breast cancer

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