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

Triple-negative Breast Cancer Clinical Trial

— NeoPACT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03639948
• Other study ID #: IIT-2017-NeoPACT
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: September 4, 2018
• Est. completion date: November 2024

Study information

• Verified date: April 2024
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: November 2024
• Est. primary completion date: January 27, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Neoplasms
• Triple-negative Breast Cancer

Intervention

Drug:
• Carboplatin
Intravenous solution
• Docetaxel
Intravenous solution
• Pembrolizumab
Intravenous solution
• Pegfilgrastim
Injectable product

Locations

Country	Name	City	State
United States	Texas Oncology- Baylor	Dallas	Texas
United States	The University of Kansas Cancer Center (KUCC)	Fairway	Kansas
United States	The University of Kansas Cancer Center, North Clinic	Kansas City	Missouri
United States	The University of Kansas Cancer Center, West Clinic	Kansas City	Kansas
United States	The University of Kansas Cancer Center, Westwood Campus	Kansas City	Kansas
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	The University of Kansas Cancer Center, Lee's Summit Clinic	Lee's Summit	Missouri
United States	The University of Kansas Medical Center	North Kansas City	Missouri
United States	The University of Kansas Cancer Center, Overland Park Clinic	Overland Park	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
University of Kansas Medical Center	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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).	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	Up to 3 years