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.
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
Drug | Synonyms | Arms |
---|
Carboplatin | | Experimental: Carboplatin & Docetaxel plus Pembroluzimab |
Docetaxel | | Experimental: Carboplatin & Docetaxel plus Pembroluzimab |
Pembrolizumab | | Experimental: Carboplatin & Docetaxel plus Pembroluzimab |
Pegfilgrastim | | Experimental: 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
Name | Type | Description | Interventions |
---|
Experimental: Carboplatin & Docetaxel plus Pembroluzimab | Experimental | 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. | - 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
Last Updated
May 3, 2021