A Phase 2 Study of Response-guided Neoadjuvant Sacituzumab Govitecan (IMMU-132) in Patients With Localized Triple-Negative Breast Cancer (NeoSTAR)

Who is this study for? Adult patients with localized triple negative breast cancer
What treatments are being studied? Sacituzumab Govitecan
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Female or male patients ≥ 18 years of age.

• Histologically confirmed diagnosis of invasive breast cancer, previously untreated.

• Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative (HER2-), invasive breast cancer. ER, PR, and HER2 positivity would be determined per ASCO/CAP guidelines by institutional (local) assessment. Patients with multi-focal and multicentric disease are eligible provided all histologically examined lesions are ER-/PR-/HER2- (local assessment). The need to biopsy additional lesions is at the discretion of the treating physician. Patients with bilateral invasive breast cancer are eligible provided all histologically examined lesions are ER-/PR-/HER2- (local assessment).

• Primary tumor (at least one lesion) 1 cm or greater measured by radiological imaging. Regional lymph node AJCC (v7) TNM stages N0-N2. If node positive, any primary tumor size is permissible. Absence of distant metastatic disease (AJCC TNM stage M0). Staging scans are not required and are per discretion of the treating physician.

• Pre- and postmenopausal women are eligible.

• ECOG performance status = 0, 1 (Karnofsky ≥60%, see Appendix A)

• Ability to understand and the willingness to sign a written informed consent form (ICF). Patient has signed the ICF prior to any screening procedures being performed and is able to comply with protocol requirements, including research biopsy.

• Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:

• Absolute neutrophil count (ANC) ≥ 1,500 per mm3

• Platelets ≥ 100,000 per mm3

• Hemoglobin ≥9.0 g/dL

• INR ≤1.5

• Serum creatinine \<1.5 mg/dL or creatinine clearance ≥50 mL/min

• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 x ULN.

• Total bilirubin ≤1.5 x ULN or in patients with well-documented Gilbert's Syndrome direct bilirubin ≤1.5 x ULN.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Massachusetts General Hospital - North Shore Cancer Center
RECRUITING
Danvers
Massachusetts General Hospital at Newton-Wellesley Hospital
RECRUITING
Newton
Contact Information
Primary
Laura Spring, MD
LSPRING2@PARTNERS.ORG
617-726-6500
Time Frame
Start Date: 2020-07-14
Estimated Completion Date: 2029-10
Participants
Target number of participants: 260
Treatments
Experimental: Sacituzumab Govitecan (monotherapy cohort)
\- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.~* Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles.~* This can be followed by standard chemotherapy at the discretion of treating physician.
Experimental: Sacituzumab Govitecan and Pembrolizumab (combination cohort)
\- The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits.~* Sacituzumab govitecan via iv, predetermined dosage per protocol, IV, 2 days per each 21-day cycle, for 4 cycles.~* Pembrolizumab via iv, predetermined dosage per protocol, IV, 1 day per each 21-day cycle, for 4 cycles.~* This can be followed by standard chemotherapy at the discretion of treating physician.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: Gilead Sciences

This content was sourced from clinicaltrials.gov