ACTIVE_NOT_RECRUITING

A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase II Study of Neoadjuvant Sacituzumab Govitecan and Pembrolizumab Therapy for Immunochemotherapy-resistant Early-stage Triple-negative Breast Cancer (TNBC)

Quick Facts

Study Start:2023-05-23

Study Completion:2026-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05675579

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Clinton Yam, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Clinton Yam, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-05-23

Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-05-23

Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer