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

NCT05675579 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2022-0431NCI-2022-10926
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  through study completion; an average of 1 year.

Study Arms (1)

Sacituzumab Govitecan and Pembrolizumab

EXPERIMENTAL

Participants will receive drug on Days 1 and 8 of Cycles 1-4, Participants will receive sacituzumab govitecan by vein. Participants will receive drug on Days 1, 8, and 15 of each cycle, Participants will receive pembrolizumab by vein.

Drug: Sacituzumab Govitecan; Drug: Pembrolizumab

Interventions

Sacituzumab Govitecan DRUG

Given by IV (vein)

Also known as: (IMMU-132) Immunomedics

Sacituzumab Govitecan and Pembrolizumab

Pembrolizumab DRUG

Given by IV (vein)

Also known as: KEYTRUDA®

Sacituzumab Govitecan and Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients 18 years of age or older.
• Histologically or cytologically confirmed breast cancer
• T1c N1-2 or T2-4 N0-2 early-stage disease
• 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)
• Initiated the NAC with the first regimen of KN-522 regimen (i.e., pembrolizumab 200 mg Q3W, given with 4 cycles of paclitaxel + carboplatin).
• ECOG performance score of 0 or 1.
• 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.
• 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.
• Agreed with undergoing the image-guided core needle biopsy after completing the first part of neoadjuvant treatment regimen.
• 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.
• The patient must have adequate organ function as determined by the following laboratory values:
• Absolute neutrophil count\* ≥ 1,500 /μL

You may not qualify if:

• Stage IV disease
• Any other previous antitumor therapies for the current cancer event.
• Pregnant or planning to become pregnant during therapy.
• Gastrointestinal tract disease or defect or previous history of colitis.
• Has an active autoimmune disease that requires systemic therapy within two years of treatment or a medical condition that requires immunosuppression.
• 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.
• 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.
• Has a cognitive impairment.
• Any other major comorbidities that can impact receiving immunotherapy or Sacituzumab govitecan.
• Have live vaccinations within 30 days prior to registration and receive study treatment.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

sacituzumab govitecan; pembrolizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinton Yam, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: January 9, 2023
• Study Start: May 23, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Locations

US (1)