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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carboplatin | Drug | Intravenous solution |
| |
| 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 |
| 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 |
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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:
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.
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.
Female subjects
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| Name | Affiliation | Role |
|---|---|---|
| Priyanka Sharma, MD | The University of Kansas Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Kansas Cancer Center (KUCC) | Fairway | Kansas | 66205 | United States | ||
| The University of Kansas Cancer Center, West Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37991778 | Derived | Sharma P, Stecklein SR, Yoder R, Staley JM, Schwensen K, O'Dea A, Nye L, Satelli D, Crane G, Madan R, O'Neil MF, Wagner J, Larson KE, Balanoff C, Kilgore L, Phadnis MA, Godwin AK, Salgado R, Khan QJ, O'Shaughnessy J. Clinical and Biomarker Findings of Neoadjuvant Pembrolizumab and Carboplatin Plus Docetaxel in Triple-Negative Breast Cancer: NeoPACT Phase 2 Clinical Trial. JAMA Oncol. 2024 Feb 1;10(2):227-235. doi: 10.1001/jamaoncol.2023.5033. |
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5 patients were found to be ineligible after enrollment and are not included in assessment for study outcomes.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Carboplatin & Docetaxel Plus Pembrolizumab | 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: Intravenous solution Docetaxel: Intravenous solution Pembrolizumab: Intravenous solution Pegfilgrastim: Injectable product |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 13, 2023 |
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| Docetaxel |
| Drug |
Intravenous solution |
|
| Pembrolizumab | Drug | Intravenous solution |
|
| Pegfilgrastim | Drug | Injectable product |
|
| 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 |
| Kansas City |
| Kansas |
| 66112 |
| United States |
| The University of Kansas Cancer Center, Westwood Campus | Kansas City | Kansas | 66205 | United States |
| University of Kansas Cancer Center | Kansas City | Kansas | 66205 | United States |
| The University of Kansas Cancer Center, Overland Park Clinic | Overland Park | Kansas | 66210 | United States |
| The University of Kansas Cancer Center, North Clinic | Kansas City | Missouri | 64154 | United States |
| The University of Kansas Cancer Center, Lee's Summit Clinic | Lee's Summit | Missouri | 64064 | United States |
| The University of Kansas Medical Center | North Kansas City | Missouri | 64116 | United States |
| Texas Oncology- Baylor | Dallas | Texas | 75246 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
Intention-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Carboplatin: Intravenous solution Docetaxel: Intravenous solution Pembrolizumab: Intravenous solution Pegfilgrastim: Injectable product |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
| ||||||||||||||||||
| Lymph node status | Count of Participants | Participants |
| ||||||||||||||||||
| T stage | Measure Description: Primary tumor stage, as defined by the 8th edition of the American Joint Committee on Cancer's staging manual. T stage indicates the size or extent of the primary tumor. T1: tumor ≤20 mm in greatest dimension; T2:tumor >20 mm but ≤50 mm in greatest dimension; T3: tumor >50 mm in greatest dimension; T4: tumor of any size with direct extension to the chest wall and/or to the skin (ulceration or skin nodules). | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Evaluable for pathologic response | Posted | Count of Participants | Participants | Up to 25 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | 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). | Residual cancer burden (RCB) class available | Posted | Count of Participants | Participants | Up to 25 weeks |
|
| |||||||||||||||||||||||||||
| Secondary | 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 | Intention-to-treat | Posted | Number | 95% Confidence Interval | Survival percentage by Kaplan-Meier | Up to 3 years |
|
|
20 weeks
Adverse events occurring in 5% or more of participants in the intent-to-treat population. Patients were systematically evaluated for toxicity at each visit. Per protocol, only adverse events determined to be definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03, are to be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Carboplatin: Intravenous solution Docetaxel: Intravenous solution Pembrolizumab: Intravenous solution Pegfilgrastim: Injectable product | 11 | 115 | 17 | 115 | 115 | 115 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Osteomyelitis | Infections and infestations | Systematic Assessment |
| ||
| Myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Cellulitis | Infections and infestations | Systematic Assessment |
| ||
| Encephalitis | Infections and infestations | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Flu-like symptoms | General disorders | Systematic Assessment |
| ||
| Bacteremia | Infections and infestations | Systematic Assessment |
| ||
| Systemic inflammatory response syndrome | General disorders | Systematic Assessment |
| ||
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Enteritis | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | Systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Peripheral sensory neuropathy | Nervous system disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Alopecia | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Mucositis oral | Gastrointestinal disorders | Systematic Assessment |
| ||
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Watering eyes | Eye disorders | Systematic Assessment |
| ||
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Edema limbs | General disorders | Systematic Assessment |
| ||
| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Bone pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Nail discoloration | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Fever | General disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Investigations | Systematic Assessment |
| ||
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypokalemia | Investigations | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Creatinine increased | Investigations | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Platelet count decreased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Priyanka Sharma | University of Kansas Medical Center | 913-588-6029 | psharma2@kumc.edu |
| Feb 9, 2024 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D016190 | Carboplatin |
| D000077143 | Docetaxel |
| C582435 | pembrolizumab |
| C455861 | pegfilgrastim |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| T3 |
|
| T4 |
|
|
|