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Trial Title:
A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)
NCT ID:
NCT05675579
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Pembrolizumab
Sacituzumab govitecan
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sacituzumab Govitecan
Description:
Given by IV (vein)
Arm group label:
Sacituzumab Govitecan and Pembrolizumab
Other name:
(IMMU-132) Immunomedics
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Given by IV (vein)
Arm group label:
Sacituzumab Govitecan and Pembrolizumab
Other name:
KEYTRUDA®
Summary:
To learn if sacituzumab govitecan and pembrolizumab, when given before surgery, can help
to control early-stage triple negative breast cancer that has not responded well to other
treatments.
Detailed description:
Primary Objective:
• To determine the efficacy of sacituzumab govitecan and pembrolizumab combination
treatment on pathological complete response (pCR)/residual cancer burden (RCB)-1 in the
patients with early-stage TNBC who showed a resistance to the combination of
immunochemotherapy.
Secondary Objectives:
- To determine the safety of the proposed combination treatment.
- To determine the objective overall response rate (ORR) of the proposed treatment.
- To determine the distant-recurrence-free survival (DRFS).
- To determine the 3-year event-free survival (EFS) rate.
- To determine the 3-year overall survival (OS) rate.
Exploratory Objective:
• To investigate the response biomarkers in the tumor tissues and peripheral blood.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Female or male patients 18 years of age or older.
2. Histologically or cytologically confirmed breast cancer
3. T1c N1-2 or T2-4 N0-2 early-stage disease
4. ER/PR negative (ER/PR <1%) or ER/PR low positive (1%≤ER/PR≤10%), and HER2 negative
as per institutional and ASCO-CAP guidelines)
5. Initiated the NAC with the first regimen of KN-522 regimen (i.e., pembrolizumab 200
mg Q3W, given with 4 cycles of paclitaxel + carboplatin).
6. ECOG performance score of 0 or 1.
7. The volumetric change of primary tumor = 0% or increase in volumetric size by US or
MRI after completing the first part of the KN-522 regimen.
8. Negative serum pregnancy test within 72 hours of receiving the first dose of the
study medication for women of childbearing potential as per institutional
guidelines. Postmenopausal women (defined as no menses for at least 1 year) and
surgically sterilized women are not required to undergo pregnancy tests.
9. Agreed with undergoing the image-guided core needle biopsy after completing the
first part of neoadjuvant treatment regimen.
10. Subjects of childbearing potential should be willing to use effective birth control
methods or be surgically sterile or abstain from heterosexual activity for the
course of the study through at least 4 months after the last dose of the study drug.
Subjects of childbearing potential are those who have not been surgically sterilized
or have not been free from menses for > 1 year. Effective methods of birth control
include:
- Use hormonal birth control methods: pills, shots/injections, implants (placed
under the skin by a health care provider), or patches (placed on the skin).
- Intrauterine devices (IUDs).
- Using 2 barrier methods (each partner must use 1 barrier method) with a
spermicide. Males must use the male condom (latex or other synthetic material)
with spermicide. Females must choose either a Diaphragm with spermicide,
cervical cap with spermicide, or a sponge.
11. The patient must have adequate organ function as determined by the following
laboratory values:
- Absolute neutrophil count* ≥ 1,500 /μL
- Platelets* ≥ 100,000 /μL
- Hemoglobin* ≥ 9 g/dL
- Creatinine clearance > 50 ml/min
- Total bilirubin ≤ 1.5 X ULN
- Alanine aminotransferase and aspartate aminotransferase < 2.5 X ULN
*Hematologic counts above should be without transfusion or growth factor
support within 2 weeks of study drug initiation.
Exclusion Criteria:
1. Stage IV disease
2. Any other previous antitumor therapies for the current cancer event.
3. Pregnant or planning to become pregnant during therapy.
4. Gastrointestinal tract disease or defect or previous history of colitis.
5. Has an active autoimmune disease that requires systemic therapy within two years of
treatment or a medical condition that requires immunosuppression.
6. Myocardial infarction within 6 months before starting therapy, symptomatic
congestive heart failure (New York Heart Association > class II), unstable angina,
or unstable cardiac arrhythmia requiring medication.
7. Has known human immunodeficiency virus (HIV) infection or active hepatitis B or C
infection (screen test is not required). Subjects positive for hepatitis C (HCV)
antibody are eligible only if the polymerase chain reaction is negative for HCV RNA.
8. Has a cognitive impairment.
9. Any other major comorbidities that can impact receiving immunotherapy or Sacituzumab
govitecan.
10. Have live vaccinations within 30 days prior to registration and receive study
treatment.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinton Yam, MD
Phone:
832-589-8343
Email:
cyam@mdanderson.org
Investigator:
Last name:
Clinton Yam, MD
Email:
Principal Investigator
Start date:
May 23, 2023
Completion date:
December 31, 2026
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Gilead Sciences
Agency class:
Industry
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05675579
http://www.mdanderson.org
