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
|Condition or disease||Intervention/treatment||Phase|
|Triple-negative Breast Cancer||Drug: Carboplatin Drug: Docetaxel Drug: Pembrolizumab Drug: Pegfilgrastim||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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).
- 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.
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
|Contact: Kerry Hepleremail@example.com|
|United States, Kansas|
|University of Kansas Cancer Center||Recruiting|
|Kansas City, Kansas, United States, 66205|
|Contact: Kerry Hepler firstname.lastname@example.org|
|Principal Investigator: Priyanka Sharma, MD|
|Principal Investigator:||Priyanka Sharma, MD||The University of Kansas Cancer Center|