Neoadjuvant TIL- and Response-Adapted Chemoimmunotherapy for TNBC

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This study will assess if the presence of immune system cells in and around the tumor impacts tumor shrinkage in patients receiving neoadjuvant chemoimmunotherapy for triple-negative breast cancer.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:

• Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent

• Female subjects 18 years of age or older

• Histologically confirmed cT1c-T3N0, cT1-T3N1-N2, cTxN1-2 TNBC

‣ The invasive tumor must be hormone receptor poor, defined as both estrogen receptor (ER) and progesterone receptor staining in ≤ 10% of invasive cancer cells by IHC

⁃ The invasive tumor must be HER2-negative based on the current ASCO-CAP guidelines

• No previous ipsilateral breast surgery for the current breast cancer

• No previous chemotherapy, immunotherapy, endocrine therapy, or radiotherapy for the current breast cancer

• ECOG Performance Status 0 - 1 documented within 21 days prior to the start of study treatment

• Breast and axillary imaging (including ultrasound and MRI) within 42 days (6 weeks) prior to treatment initiation

• Subjects with clinically and/or radiographically abnormal axillary or internal mammary lymph nodes should have pathologic confirmation of disease status with image-guided biopsy or fine needle aspiration

• Archival breast tumor tissue has been obtained or has been requested for use

• No clinically apparent metastatic disease. Staging to rule out metastatic disease is suggested for patients with clinical TNM stage III disease

• Subjects with bilateral synchronous TNBC are eligible if they meet other eligibility criteria

• No baseline neuropathy greater than grade 2

• Patients are not pregnant, not breastfeeding, and either not a woman of childbearing potential or agrees to follow specific contraceptive guidelines during the treatment period and for at least 120 days after the last dose of study treatment

• Adequate hematologic, hepatic, and renal function assessed ≤ 21 days from treatment initiation

• Only if assigned to Regimen C, LVEF ≥ 50% by echocardiogram or MUGA scan, per standard of care (assessed within 120 days prior to receiving doxorubicin + cyclophosphamide)

Locations
United States
Kansas
The University of Kansas Cancer Center - Clinical Research Center
RECRUITING
Fairway
The University of Kansas Cancer Center - Main Hospital
RECRUITING
Kansas City
The University of Kansas Cancer Center - Westwood
RECRUITING
Kansas City
The University of Kansas Cancer Center - Overland Park
RECRUITING
Overland Park
Missouri
The University of Kansas Cancer Center - North
RECRUITING
Kansas City
The University of Kansas Cancer Center - Lee's Summit
RECRUITING
Lee's Summit
University of Kansas Cancer Center at North Kansas City Hospital
RECRUITING
North Kansas City
Contact Information
Primary
KUCC Navigation
kucc_navigation@kumc.edu
9135883671
Backup
Laura Mitchell
lmitchell11@kumc.edu
9135742854
Time Frame
Start Date: 2022-12-05
Estimated Completion Date: 2026-12
Participants
Target number of participants: 139
Treatments
Active_comparator: High sTILs (≥30%)
Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles.
Active_comparator: Intermediate sTILs (5-29%)
Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for six cycles.
Active_comparator: Low sTILs (<5%)
Carboplatin (AUC=6) + Docetaxel (75 mg/m2) + Pembrolizumab (200 mg) every 21 days for four cycles followed by Doxorubicin (60 mg/m2) + Cyclophosphamide (600 mg/m2) + Pembrolizumab (200 mg) every 14 or 21 days for four cycles.
Sponsors
Leads: University of Kansas Medical Center

This content was sourced from clinicaltrials.gov