Clinical Trials Logo
  1. Home
  2. Triple Negative Breast Cancer
  3. NCT04230109

Sacituzumab Govitecan In TNBC — NeoSTAR  

Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial 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)

Clinical Trial Description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational drug to learn whether the drug works in treating a specific disease. "Investigational" means that the drug is being studied. This research study involves an experimental study treatment. The names of the study drugs involved in this study is: - Sacituzumab govitecan (SG) - Pembrolizumab (combination therapy with SG) The study is a umbrella study multi-arm phase II study of neoadjuvant SG-based therapy in patients with localized BC. The first cohort involves SG monotherapy. After the monotherapy cohort completes enrollment, the combination therapy cohort (SG with pembrolizumab) for patients with localized BC will open. Future planned arms include SG with/without pembrolizumab for patients with Hormone Receptor positive (HR+) breast cancer and inflammatory breast cancer (IBC). The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. - Eligible participants will receive Sacituzumab govitecan for up to 12 weeks. - This can be followed by standard chemotherapy at the discretion of the treating physician. - It is expected that about 50 people will take part in this research study. The U.S. Food and Drug Administration (FDA) has not approved Sacituzumab govitecan as a treatment for patients with metastatic TNBC. Sacituzumab govitecan (SG) is an antibody-drug conjugate which means it's made up of an antibody attached to an anticancer drug. An antibody is a protein normally made the immune system. Sacituzumab govitecan is believed to work by binding the antibody portion of the drug in the tumor(s) while the anticancer drug portion works to prevent cancer cells from growing/spreading. After the SG monotherapy cohort completes enrollment, the combination therapy cohort (SG with immunotherapy) will open. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04230109
Study type Interventional
Source Massachusetts General Hospital
Contact Laura Spring, MD
Phone 617-726-6500
Email LSPRING2@PARTNERS.ORG
Status Recruiting
Phase Phase 2
Start date July 14, 2020
Completion date October 2026
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05174832 - Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients Phase 2
Active, not recruiting NCT03667716 - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors. Phase 1
Withdrawn NCT03634150 - Safety and Efficacy of IV Nerofe™ Followed by Doxorubicin, In Metastatic Ovarian Cancer and Triple Negative Breast Cancer Phase 1/Phase 2
Recruiting NCT03348098 - Clinical Study of Neoadjuvant Therapy With Apatinib and Paclitaxel in Local Advanced Triple-negative Breast Cancer Phase 2
Completed NCT04032080 - LY3023414 and Prexasertib in Metastatic Triple-negative Breast Cancer Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Not yet recruiting NCT06318897 - Open-label, Single Center, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab in Combination With Carboplatin and Paclitaxel in Patients With Stage 1 cT1b-T1cN0M0 Triple Negative Breast Cancer Phase 2
Withdrawn NCT02427581 - Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy Phase 1
Recruiting NCT03165487 - Comparison of the Breast Tumor Microenvironment
Completed NCT02225470 - Eribulin Versus Vinorelbine in Subjects With Locally Recurrent or Metastatic Breast Cancer Previously Treated With Anthracyclines and Taxanes Phase 3
Recruiting NCT04452370 - Oral Etoposide Combined With Anlotinib in Advanced Triple Negative Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Recruiting NCT04758780 - Imaging Performance Assessment of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET-CT in Metastatic Triple Negative Breast Cancer Patients Phase 2
Not yet recruiting NCT06351332 - A Phase I/II Single-arm Trial of Azenosertib (ZN-c3) Combined With Carboplatin and Pembrolizumab in Patients With Metastatic Triple-negative Breast Cancer (ZAP-IT) Phase 1/Phase 2
Withdrawn NCT04268693 - Bisphenol and Phthalate Exposures in Triple Negative Breast Cancer
Withdrawn NCT03982173 - Basket Trial for Combination Therapy With Durvalumab (Anti-PDL1) (MEDI4736) and Tremelimumab (Anti-CTLA4) in Patients With Metastatic Solid Tumors Phase 2
Not yet recruiting NCT02685657 - Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer Phase 2
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT01276899 - Study to Identify Molecular Mechanisms of Clinical Resistance to Chemotherapy in Triple Negative Breast Cancer Patients
Completed NCT00998036 - Study of Temsirolimus, Erlotinib and Cisplatin in Solid Tumors Phase 1